Medicines and Medical Devices Act 2021

February 10, 2021

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<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="part-1"><num>PART 1</num><heading>The Commissioner for Patient Safety</heading><section eId="section-1"><num>1</num><heading>Establishment and core duties etc</heading><subsection eId="section-1-1"><num>(1)</num><content>T

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-1"><num>1</num><heading>Establishment and core duties etc</heading><subsection eId="section-1-1"><num>(1)</num><content>The Secretary of State must appoint a Commissioner for Patient Safety (referred to in this Part as

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-1-1"><num>(1)</num><content>The Secretary of State must appoint a Commissioner for Patient Safety (referred to in this Part as “<term refersTo="#term-the-commissioner" eId="term-the-commissioner">the Commissioner</

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-1-2"><num>(2)</num><intro>The Commissioner's core duties are to—</intro><level class="para1" eId="section-1-2-a"><num>(a)</num><content>promote the safety of patients with regard to the use of medicines and m

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-1-2-a"><num>(a)</num><content>promote the safety of patients with regard to the use of medicines and medical devices, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-1-2-b"><num>(b)</num><content>promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-1-3"><num>(3)</num><content>The Commissioner is not to be regarded as the servant or agent of the Crown or as enjoying any status, immunity or privilege of the Crown.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-1-4"><num>(4)</num><content>Schedule 1 makes further provision about the Commissioner.</content></subsection>

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="part-2"><num>PART 2</num><heading>Human medicines</heading><chapter eId="part-2-chapter-1"><num>CHAP

<chapter xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="part-2-chapter-1"><num>CHAPTER 1</num><heading><ins class="substitution first last" ukl:ChangeId="key-8c

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-2"><num>2</num><heading>Power to make regulations about human medicines</heading><subsection eId="section-2-1"><num>(1)</num><content>The appropriate authority may by regulations make provision specified in sections 3

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-2-1"><num>(1)</num><content>The appropriate authority may by regulations make provision specified in sections 3 to 7 amending or supplementing the law relating to human medicines.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-2-2"><num>(2)</num><content>In making regulations under subsection (1), the appropriate authority's overarching objective must be safeguarding public health.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-2-3"><num>(3)</num><intro>In considering whether regulations under subsection (1) would contribute to this objective, the appropriate authority must have regard to—</intro><level class="para1" eId="section-2-3-a

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-2-3-a"><num>(a)</num><content>the safety of human medicines;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-2-3-b"><num>(b)</num><content>the availability of human medicines;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-2-3-c"><num>(c)</num><intro>the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to—</intro><level class="para2" eId="section-2-3-c-i"><num>(i)</num><conte

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-2-3-c-i"><num>(i)</num><content>carry out research relating to human medicines,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-2-3-c-ii"><num>(ii)</num><content>conduct clinical trials, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-2-3-c-iii"><num>(iii)</num><content>manufacture or supply human medicines.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-2-4"><num>(4)</num><content>Where regulations under subsection (1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the ben

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-2-5"><num>(5)</num><intro>In subsection (3)(c), “<term refersTo="#term-relevant-part-of-the-united-kingdom" eId="term-relevant-part-of-the-united-kingdom">relevant part of the United Kingdom</term>” means—</int

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-2-5-a"><num>(a)</num><content>so far as the regulations relate to England and Wales and Scotland, those parts of the United Kingdom, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-2-5-b"><num>(b)</num><content>so far as the regulations relate to Northern Ireland, that part of the United Kingdom.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-2-6"><num>(6)</num><intro>In this Part, “<term refersTo="#term-appropriate-authority" eId="term-appropriate-authority">appropriate authority</term>” means—</intro><level class="para1" eId="section-2-6-a"><num>(

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-2-6-a"><num>(a)</num><content>in relation to England and Wales and Scotland, the Secretary of State, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-2-6-b"><num>(b)</num><intro>in relation to Northern Ireland—</intro><level class="para2" eId="section-2-6-b-i"><num>(i)</num><content>the Department of Health in Northern Ireland, or</content></l

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-2-6-b-i"><num>(i)</num><content>the Department of Health in Northern Ireland, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-2-6-b-ii"><num>(ii)</num><content>the Department of Health in Northern Ireland and the Secretary of State acting jointly.</content></level>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-3"><num>3</num><heading>Manufacture, marketing and supply</heading><subsection eId="section-3-1"><num>(1)</num><intro>Regulations under section 2(1) may make provision about—</intro><level class="para1" eId="sectio

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-3-1"><num>(1)</num><intro>Regulations under section 2(1) may make provision about—</intro><level class="para1" eId="section-3-1-a"><num>(a)</num><content>authorisations to manufacture human medicines,</co

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-a"><num>(a)</num><content>authorisations to manufacture human medicines,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-b"><num>(b)</num><content>authorisations to import human medicines,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-c"><num>(c)</num><content>authorisations to distribute human medicines by way of wholesale dealing,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-d"><num>(d)</num><content>marketing authorisations,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-e"><num>(e)</num><content>manufacturing, importing or distributing active substances,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-f"><num>(f)</num><content>brokering in relation to human medicines,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-g"><num>(g)</num><content>the registration of the premises of pharmacy businesses,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-h"><num>(h)</num><content>the recording of information about the supply of human medicines,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-i"><num>(i)</num><content>notification and reporting requirements in relation to human medicines that have been placed on the market,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-j"><num>(j)</num><content>the labelling and packaging of human medicines or the information that must be supplied with them or made available in relation to them,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-k"><num>(k)</num><content>advertising with regard to human medicines,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-l"><num>(l)</num><content>the registration of persons who supply or offer to supply human medicines by means of the internet,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-m"><num>(m)</num><content>the requirements that must be met in relation to a prescription,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-n"><num>(n)</num><content>prohibitions in the provisions mentioned in subsection (2), or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-1-o"><num>(o)</num><content>the use of tissues or cells (within the meanings given by regulation 5(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523)) in r

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-3-2"><num>(2)</num><intro>Subsection (1)(n) refers to the following provisions in the Human Medicines Regulations 2012 (S.I. 2012/1916)—</intro><level class="para1" eId="section-3-2-a"><num>(a)</num><content>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-2-a"><num>(a)</num><content>regulation 214 and Schedule 13 (sale or supply of prescription only medicines),</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-2-b"><num>(b)</num><content>regulation 215 and Schedule 14 (prescribing and administration by supplementary prescribers),</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-2-c"><num>(c)</num><content>regulation 220 (sale or supply of human medicines not subject to general sale),</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-2-d"><num>(d)</num><content>regulation 221 and Schedule 15 (sale or supply of medicinal products subject to general sale), and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-3-2-e"><num>(e)</num><content>regulation 249 and Schedule 22 (restrictions on persons to be supplied with medicinal products).</content></level>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-4"><num>4</num><heading>Falsified medicines</heading><subsection eId="section-4-1"><num>(1)</num><intro>Regulations under section 2(1) may make provision about—</intro><level class="para1" eId="section-4-1-a"><num>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-4-1"><num>(1)</num><intro>Regulations under section 2(1) may make provision about—</intro><level class="para1" eId="section-4-1-a"><num>(a)</num><content>the prevention of the supply of falsified human medici

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-4-1-a"><num>(a)</num><content>the prevention of the supply of falsified human medicines, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-4-1-b"><num>(b)</num><content>the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines.</

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-4-2"><num>(2)</num><intro>Provision made in reliance on subsection (1)(a) may (among other things) make provision—</intro><level class="para1" eId="section-4-2-a"><num>(a)</num><intro>for human medicines that

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-4-2-a"><num>(a)</num><intro>for human medicines that are subjects of a marketing authorisation to be supplied in packs that—</intro><level class="para2" eId="section-4-2-a-i"><num>(i)</num><content>c

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-4-2-a-i"><num>(i)</num><content>carry unique identifiers associated with the products, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-4-2-a-ii"><num>(ii)</num><content>are protected with anti-tamper devices,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-4-2-b"><num>(b)</num><content>for checks to be carried out in relation to packs that have or should have such a unique identifier,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-4-2-c"><num>(c)</num><intro>about the infrastructure, systems and processes required for the allocation and checking of unique identifiers, including provision about—</intro><level class="para2" eId="se

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-4-2-c-i"><num>(i)</num><content>who is to set up the infrastructure, systems and processes,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-4-2-c-ii"><num>(ii)</num><content>who is to maintain them, and</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-4-3"><num>(3)</num><content>In making regulations in reliance on subsection (1), the appropriate authority must have regard to the importance of ensuring that information is retained securely.</content></subsect

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-5"><num>5</num><heading>Clinical trials</heading><subsection eId="section-5-1"><num>(1)</num><intro>Regulations under section 2(1) may make provision—</intro><level class="para1" eId="section-5-1-a"><num>(a)</num><

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-5-1"><num>(1)</num><intro>Regulations under section 2(1) may make provision—</intro><level class="para1" eId="section-5-1-a"><num>(a)</num><content>corresponding or similar to provision in the EU Clinical Tri

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-5-1-a"><num>(a)</num><content>corresponding or similar to provision in the EU Clinical Trials Regulation,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-5-1-b"><num>(b)</num><content>about authorisations concerning clinical trials in the United Kingdom, including applications for an assessment of the ethics of a proposed clinical trial,</content></level

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-5-1-c"><num>(c)</num><content>about notification and reporting requirements in relation to clinical trials,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-5-1-d"><num>(d)</num><content>about requirements that must be met before a clinical trial may be carried out, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-5-1-e"><num>(e)</num><content>relating to the conduct of clinical trials.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-5-2"><num>(2)</num><content>In subsection (1)(a), “<term refersTo="#term-eu-clinical-trials-regulation" eId="term-eu-clinical-trials-regulation">EU Clinical Trials Regulation</term>” means Regulation (EU) No 536/20

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-6"><num>6</num><heading>Fees, offences, powers of inspectors</heading><subsection eId="section-6-1"><num>(1)</num><intro>Regulations under section 2(1) may make provision—</intro><level class="para1" eId="section-6

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-6-1"><num>(1)</num><intro>Regulations under section 2(1) may make provision—</intro><level class="para1" eId="section-6-1-a"><num>(a)</num><content>about the charging of fees in connection with the exercise o

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-6-1-a"><num>(a)</num><content>about the charging of fees in connection with the exercise of a function conferred by a human medicines provision,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-6-1-b"><num>(b)</num><content>creating a criminal offence of failing to comply with a provision made in the regulations, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-6-1-c"><num>(c)</num><content>applying relevant powers of entry or other powers of inspectors with or without modification in relation to a prohibition or requirement in provision made in the regulations.</

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-6-2"><num>(2)</num><content>Regulations under section 2(1) may not provide for an offence to be punishable with a sentence of imprisonment of more than two years.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-6-3"><num>(3)</num><intro>In subsection (1), “<term refersTo="#term-relevant-powers-of-entry-or-other-powers-of-inspectors" eId="term-relevant-powers-of-entry-or-other-powers-of-inspectors">relevant powers of entry

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-6-3-a"><num>(a)</num><content>Part 8 of the Medicines Act 1968;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-6-3-b"><num>(b)</num><content>the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031);</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-6-3-c"><num>(c)</num><content>Part 16 of the Human Medicines Regulations 2012 (S.I. 2012/1916).</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-6-4"><num>(4)</num><intro>In this Part, “<term refersTo="#term-human-medicines-provision" eId="term-human-medicines-provision">human medicines provision</term>” means a provision in—</intro><level class="para1"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-6-4-a"><num>(a)</num><content>regulations under section 2(1),</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-6-4-b"><num>(b)</num><content>the Human Medicines Regulations 2012, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-6-4-c"><num>(c)</num><content>the Medicines for Human Use (Clinical Trials) Regulations 2004.</content></level>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-7"><num>7</num><heading>Emergencies</heading><subsection eId="section-7-1"><num>(1)</num><content>Regulations under section 2(1) may make provision about the disapplication of a human medicines provision in circumstanc

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-7-1"><num>(1)</num><content>Regulations under section 2(1) may make provision about the disapplication of a human medicines provision in circumstances which give rise to a need to protect the public from a risk of s

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-7-2"><num>(2)</num><intro>Regulations made in reliance on subsection (1) may provide for the disapplication to be subject to—</intro><level class="para1" eId="section-7-2-a"><num>(a)</num><content>conditions

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-7-2-a"><num>(a)</num><content>conditions set out in the regulations;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-7-2-b"><num>(b)</num><content>conditions set out in a protocol published by the appropriate authority.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-7-3"><num>(3)</num><intro>Where regulations made in reliance on subsection (1) provide that the appropriate authority may publish a protocol setting out conditions, the regulations must provide—</intro><level cl

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-7-3-a"><num>(a)</num><content>that the appropriate authority may withdraw or amend the protocol, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-7-3-b"><num>(b)</num><content>that the protocol is to have effect only for a period of time specified in the protocol.</content></level>

<chapter xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="part-2-chapter-2"><num>CHAPTER 2</num><heading>International agreements: disclosure of information</heading><section eId="section-8"><num>8</num><heading>Disclosure

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-8"><num>8</num><heading>Disclosure of information in accordance with international agreements</heading><subsection eId="section-8-1"><num>(1)</num><content>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-8-1"><num>(1)</num><content>This section applies to information which a relevant authority holds in connection with human medicines.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-8-2"><num>(2)</num><intro>The relevant authority may disclose information to a relevant person outside the United Kingdom where—</intro><level class="para1" eId="section-8-2-a"><num>(a)</num><content>the disc

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-8-2-a"><num>(a)</num><content>the disclosure is required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicines, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-8-2-b"><num>(b)</num><content>the relevant authority considers that the disclosure is in the public interest.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-8-3"><num>(3)</num><intro>The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority—</intro><level class="para1" eId="section-8-3-a"><

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-8-3-a"><num>(a)</num><content>considers that it is necessary to do so for the purpose mentioned in that subsection, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-8-3-b"><num>(b)</num><content>is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-8-4"><num>(4)</num><intro>Except as provided by subsections (5) and (6), the disclosure of information in accordance with this section does not breach—</intro><level class="para1" eId="section-8-4-a"><num>(a)</n

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-8-4-a"><num>(a)</num><content>an obligation of confidence owed by the person making the disclosure, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-8-4-b"><num>(b)</num><content>any other restriction on the disclosure of the information (however imposed).</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-8-5"><num>(5)</num><content>Nothing in this section authorises a disclosure of patient information without the consent of the individual to whom that information relates.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-8-6"><num>(6)</num><intro>Nothing in this section authorises a disclosure of information which—</intro><level class="para1" eId="section-8-6-a"><num>(a)</num><content>contravenes the data protection legislati

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-8-6-a"><num>(a)</num><content>contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), or</content></lev

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-8-6-b"><num>(b)</num><content>is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-8-7"><num>(7)</num><content>This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-8-8"><num>(8)</num><intro>In this section—</intro><hcontainer name="definition"><content>“<term refersTo="#term-commercially-sensitive-informat

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content>“pharmacy business” means a business (other than a professional practice carried on by a doctor or dentist) which consists of or includes the sale of medicinal products that are not subject to general

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" name="schedule" eId="schedule-1"><num>SCHEDULE 1<authorialNote class="referenceNote"> Section 1</au

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-1-crossheading-principles-relating-to-core-duties"><heading>Principles relating to core duties</heading><pa

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-1-crossheading-involvement-of-patients"><heading>Involvement of patients</heading><paragraph eId="schedule-

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-1-crossheading-supplementary-functions-and-information"><heading>Supplementary functions and information</h

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-1-crossheading-individual-cases"><heading>Individual cases</heading><paragraph eId="schedule-1-paragraph-4"

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" name="crossheading" ukl:Name="Pblock" eId="schedule-1-crossheading-amendments-to-primary-legislation"><hea

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-1-crossheading-regulations-about-appointment-and-operation"><heading>Regulations about appointment and operatio

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" name="schedule" eId="schedule-2"><num>SCHEDULE 2<authorialNote class="referenceNote"> Section 31</a

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="schedule-2-part-1"><num>PART 1</num><heading>Monetary penalties</heading><hcontainer name="crosshead

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-1-crossheading-notices-representations-and-appeals-etc"><heading>Notices, representations and appeals et

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-1-crossheading-information-to-be-included-in-notices-under-paragraph-2"><heading>Information to be inclu

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-1-crossheading-monetary-penalties-criminal-proc

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="schedule-2-part-2"><num>PART 2</num><heading>Enforcement undertakings</heading><paragraph eId="sched

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="schedule-2-paragraph-5" class="schProv1"><num>5</num><subparagraph eId="schedule-2-paragraph-5-1"><num

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="schedule-2-part-3"><num>PART 3</num><heading>Enforcement costs recovery notices</heading><hcontainer name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-3-crossheading-imposition-of-enforcement-costs-recovery-notices"><heading>Imposition of enforcement cost

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content>“<term refersTo="#term-compliance-notice" eId="term-compliance-notice">compliance notice</term>” has the meaning given by section 21(2);</content></hcontainer>

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-7" class="schProv1"><num>7</num><subparagraph eId="schedule-2-paragraph-7-1"><num>(1)</num><intro>An enforcement costs recovery notice must specify the amount to be paid and must include information as t

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-10" class="schProv1"><num>10</num><subparagraph eId="schedule-2-paragraph-10-1"><num>(1)</num><intro>Supplementary regulations may make provision of any of the following sorts in relation to the power of

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content>“<term refersTo="#term-information-notice" eId="term-information-notice">information notice</term>” has the meaning given by section 24(2);</content></hcontainer>

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-3-crossheading-information-to-be-included-in-enforcement-costs-recovery-notices"><heading>Information to

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-3-crossheading-appeals"><heading>Appeals</heading><paragraph eId="schedule-2-paragraph-8" class="sch

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="schedule-2-part-4"><num>PART 4</num><heading>Power to make supplementary provision etc by regulations</heading><hcontainer name="crossheading" ukl:Name="Pblock"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1"><num>(b)</num><content>in relation to regulations made under section 2(1) <ins class="first l

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-9" class="schProv1"><num>9</num><subparagraph eId="schedule-2-paragraph-9-1"><num>(1)</num><intro>The Secretary of State may by regulations (“<term refersTo="#term-supplementary-regulations" eId="term-su

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-12" class="schProv1"><num>12</num><subparagraph eId="schedule-2-paragraph-12-1"><num>(1)</num><intro>Supplementary regulations may make provision of any of the following sorts in relation to an appeal in

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-4-crossheading-supplementary-regulations-general"><heading>Supplementary regulations: general</headi

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-4-crossheading-monetary-penalties-and-costs"><heading>Monetary penalties and costs</heading><paragra

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-4-crossheading-enforcement-undertakings"><heading>Enforcement undertakings</heading><paragraph eId="

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-4-crossheading-appeals"><heading>Appeals</heading><paragraph eId="schedule-2-paragraph-12" class="sc

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="schedule-2-part-5"><num>PART 5</num><heading>General and supplemental</heading><hcontainer name="cro

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-5-crossheading-guidance-as-to-enforcement"><hea

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-5-crossheading-precommencement-consultation"><heading>Pre-commencement consultation</heading><paragr

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-5-crossheading-reports-on-use-of-civil-sanctions"><heading>Reports on use of civil sanctions</headin

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="schedule-2-part-5-crossheading-disclosure-of-information"><heading>Disclosure of information</heading><paragraph eId

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-part-6"><num>PART 6</num><heading>Interpretation</heading><paragraph eId="schedule-2-paragraph-17" class="schProv1"><num>17</num><intro>In this Schedule—</intro><hcontainer name="definition"><content>“<te

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-17" class="schProv1"><num>17</num><intro>In this Schedule—</intro><hcontainer name="definition"><content>“<term refersTo="#term-enforcement-costs-recovery-notice" eId="term-enforcement-costs-recov

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1"><num>(a)</num><content>Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive <ref eId="c00005" href="http://www.legislation.gov.uk/id/eudr/2001/83"

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:default="http://www.w3.org/1999/xhtml" name="schedule" eId="schedule-3"><num>SCHEDULE 3<authorialNot

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="schedule-3-part-1"><num>PART 1</num><heading>Offence</heading><paragraph eId="schedule-3-paragraph-1

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="schedule-3-paragraph-1" class="schProv1"><num>1</num><content><mod>In the Medical Devices Regulatio

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:default="http://www.w3.org/1999/xhtml" eId="schedule-3-part-2"><num>PART 2</num><heading>Provisions

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:default="http://www.w3.org/1999/xhtml" eId="schedule-3-paragraph-2" class="schProv1"><num>2</num><con

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" name="definition"><intro> <ins class="substitution first" ukl:ChangeId="key-d459595a3ae02cf9b58c87f4fd1

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-14" class="schProv1"><num>14</num><content>If, before the day on which this Schedule comes into force, any consultation was undertaken which, had it been undertaken after that day, would to any extent ha

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1"><num>(a)</num><content>relates to—<blockList class="ordered roman parens" ukl:Name="OrderedList" ukl:Type="roman" ukl:Decoration="parens"><item><num>(

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1"><num>(b)</num><content>the Department of Agriculture, Environment and Rural Affairs in Northern Ireland;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1"><num>(b)</num><content>in Scotland, the Sheriff Appeal Court;</content></level>

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content>“<term refersTo="#term-clinical-trial" eId="term-clinical-trial">clinical trial</term>” has the meaning given by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I.

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-1-paragraph-1" class="schProv1"><num>1</num><subparagraph eId="schedule-1-paragraph-1-1"><num>(1)</num><content>The Commissioner must prepare and publish a set of principles to govern the way in which the Commission

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-1-paragraph-4" class="schProv1"><num>4</num><subparagraph eId="schedule-1-paragraph-4-1"><num>(1)</num><content>The Commissioner may not exercise functions in relation to an individual case.</content></subparagr

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-6" class="schProv1"><num>6</num><subparagraph eId="schedule-2-paragraph-6-1"><num>(1)</num><content>The Secretary of State may serve an enforcement costs recovery notice on a person on whom a monetary pe

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1"><num>(c)</num><content>in relation to regulations made under section 15(1) or 19(1), the Secretary of State.</content></level>

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="schedule-2-paragraph-1" class="schProv1"><num>1</num><subparagraph eId="schedule-2-paragraph-1-1"><num

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="schedule-2-paragraph-4" class="schProv1"><num>4</num><subparagraph eId="schedule-2-paragraph-4-1"><num

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="schedule-2-paragraph-13" class="schProv1"><num>13</num><subparagraph eId="schedule-2-paragraph-13-1"><

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-16" class="schProv1"><num>16</num><subparagraph eId="schedule-2-paragraph-16-1"><num>(1)</num><intro>Information may be disclosed to the Secretary of State for the purpose of the exercise by the Secretar

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1"><num>(a)</num><content>the government of a country or territory outside the United Kingdom;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1"><num>(a)</num><content>in relation to regulations made under section 2(1) <ins class="first l

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1"><num>(c)</num><content>any other person who exercises functions or provides services relating to veterinary medicines in a country or territory outside the United Kingdom;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1"><num>(c)</num><content>any other person who exercises functions or provides services relating to medical devices in a country or territory outside the United Kingdom;</content></level>

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content>“<term refersTo="#term-active-substance" eId="term-active-substance">active substance</term>” has the meaning given by regulation 8 of the Human Medicines Regulations 2012 (S.I. 2012/1916);</conten

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-3" class="schProv1"><num>3</num><subparagraph eId="schedule-2-paragraph-3-1"><num>(1)</num><intro>A notice under paragraph 2(1) must include information as to—</intro><level class="para1" eId="schedu

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-11" class="schProv1"><num>11</num><intro>Supplementary regulations may make provision of any of the following sorts in relation to an enforcement undertaking—</intro><level class="para1" eId="schedul

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="schedule-2-paragraph-11-a"><num>(a)</num><content>provision as to the procedure for entering into an undertaking;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="schedule-2-paragraph-11-b"><num>(b)</num><content>provision as to the terms of an undertaking;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="schedule-2-paragraph-11-c"><num>(c)</num><content>provision as to publication of an undertaking by the Secretary of State;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="schedule-2-paragraph-11-d"><num>(d)</num><content>provision as to variation of an undertaking;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="schedule-2-paragraph-11-e"><num>(e)</num><content>provision as to circumstances in which a person may be regarded as having complied with an undertaking;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="schedule-2-paragraph-11-f"><num>(f)</num><content>provision as to monitoring by the Secretary of State of compliance with an undertaking;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="schedule-2-paragraph-11-g"><num>(g)</num><content>provision as to certification by the Secretary of State that an undertaking has been complied with;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="schedule-2-paragraph-11-h"><num>(h)</num><content>provision for appeals against refusal to give such certification;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="schedule-2-paragraph-11-i"><num>(i)</num><content>in a case where a person has given inaccurate, misleading or incomplete information in relation to an undertaking, provision for the person to be regarded as not ha

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="schedule-2-paragraph-11-j"><num>(j)</num><content>in a case where a person has complied partly but not fully with an undertaking, provision for that part-compliance to be taken into account in the imposition of any

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1"><num>(d)</num><content>an international organisation that exercises functions or provides services relating to medical devices.</content></level>

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="definition"><content><ins class="substitution" ukl:ChangeId="key-d459595a3ae02cf9b58c87f4fd1dd150-1631884403759" ukl:CommentaryRef="key-d459595a3ae02cf9b58c8

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1"><num>(b)</num><content>a person who exercises functions on behalf of such a government;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1"><num>(c)</num><content>any other person who exercises functions or provides services relating to medical devices in a country or territory outside the United Kingdom;</content></level>

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content>“<term refersTo="#term-parliamentary-committee" eId="term-parliamentary-committee">Parliamentary Committee</term>” means a committee of the House of Commons or of the House of Lords or a joint committe

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-1-paragraph-2" class="schProv1"><num>2</num><subparagraph eId="schedule-1-paragraph-2-1"><num>(1)</num><content>The Commissioner must take reasonable steps to involve patients in the discharge of the Commissioner's

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="schedule-1-paragraph-5" class="schProv1"><num>5</num><subparagraph eId="schedule-1-paragraph-5-1"><num

<chapter xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="part-2-chapter-1A"><num><ins class="first" ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-7A"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRe

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-7A-1"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:Comment

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-1-a"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(a)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-1-b"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(b)

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-7A-2"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:Comment

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-2-a"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(a)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-7A-2-b"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-2-c"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(c)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-7A-2-d"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796"

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-7A-3"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:Comment

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-3-a"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(a)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-7A-3-b"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-3-c"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(c)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-3-d"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(d)

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-7A-4"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:Comment

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-7A-4-a"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-7A-4-b"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-7A-4-c"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-7A-4-d"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-4-e"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(e)

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-7A-5"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(5)</ins></num

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-5-a"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(a)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-5-b"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(b)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-5-c"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(c)

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-7A-6"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:Comment

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-7A-6-a"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-7A-6-b"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-6-c"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(c)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-6-d"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(d)

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-7A-7"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(7)</ins></num

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-7-a"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(a)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-7-b"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(b)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para2" eId="section-7A-7-b-i"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-7A-8"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:Comment

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-7A-9"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:Comment

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-7A-9-a"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-9-b"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(b)

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-7A-10"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:Commen

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-7A-11"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:Commen

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-7A-12"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(12)</ins></n

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-12-a"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(a

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7A-12-b"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(b

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-7A-13"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(13)</ins></n

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-7B"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">7B</ins></num><head

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-7B-1"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(1)</ins></num

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-7B-2"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(2)</ins></num

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7B-2-a"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(a)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-7B-2-b"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(b)

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-7B-3"><num><ins ukl:ChangeId="key-7252f90947939d63f25cb7b4d4dd7ce9-1664362957796" ukl:CommentaryRef="key-7252f90947939d63f25cb7b4d4dd7ce9">(3)</ins></num

<chapter xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="part-2-chapter-3"><num>CHAPTER 3</num><heading>Interpretation</heading><section eId="section-9"><num>9</num><heading>Interpretation of Part 2</heading><intro>In this Part—</intro><hcontainer name="definition"><content>“

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-9"><num>9</num><heading>Interpretation of Part 2</heading><intro>In this Part—</intro><hcontainer name="definition"><content>“<term refersTo="#term-active-substance" eId="term-active-substance">active substance<

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content>“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;</content></hcontainer>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1"><num>(a)</num><content>sections 10 and 15, and Part 4, and section 131 of the Medicines Act 1968 (which make provision relating to pharmacies),</content></level>

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="crossheading" class="schGroup7"><heading>Supplementary functions and information</heading><paragraph eId="schedule-1-paragraph-3" class="schProv1"><num>3</num><subparagraph eId="schedule-1-paragraph-3-1"><num>(1)</num><intro>

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-1-paragraph-3" class="schProv1"><num>3</num><subparagraph eId="schedule-1-paragraph-3-1"><num>(1)</num><intro>For the purposes of carrying out the core duties, the Commissioner may—</intro><level class="para1" e

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-1-paragraph-6" class="schProv1"><num>6</num><subparagraph eId="schedule-1-paragraph-6-1"><num>(1)</num><content>The Secretary of State may by regulations make such provision as the Secretary of State considers appro

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="definition"><intro>the “<term refersTo="#term-enforcement-authority" eId="term-enforcement-authority">enforcement authority</term>” means—</intro><level

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-2" class="schProv1"><num>2</num><subparagraph eId="schedule-2-paragraph-2-1"><num>(1)</num><content>Where the Secretary of State proposes to impose a monetary penalty on a person, the Secretary of State

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><intro>“<term refersTo="#term-law-relating-to-human-medicines" eId="term-law-relating-to-human-medicines">law relating to human medicines</term>” means—</intro><level class="para1"><num>(a)</num><content><p

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-8" class="schProv1"><num>8</num><subparagraph eId="schedule-2-paragraph-8-1"><num>(1)</num><intro>A person served with an enforcement costs recovery notice may appeal against the decision to serve it on

<paragraph xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="schedule-2-paragraph-15" class="schProv1"><num>15</num><subparagraph eId="schedule-2-paragraph-15-1"><num>(1)</num><content>The Secretary of State must from time to time publish reports about the use made by the Secretary of

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="part-3"><num>PART 3</num><heading>Veterinary medicines</heading><chapter eId="part-3-chapter-1"><num>CHAPTER 1</num><heading>Regulations</heading><section eId="section-10"><num>10</num><heading>Power to make regulations about

<chapter xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="part-3-chapter-1"><num>CHAPTER 1</num><heading>Regulations</heading><section eId="section-10"><num>10</num><heading>Power to make regulations about veterinary medicines</heading><subsection eId="section-10-1"><num>(1)</num><conte

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-10"><num>10</num><heading>Power to make regulations about veterinary medicines</heading><subsection eId="section-10-1"><num>(1)</num><content>The appropriate authority may by regulations make provision specified in sec

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-10-1"><num>(1)</num><content>The appropriate authority may by regulations make provision specified in sections 11 and 12 amending or supplementing the Veterinary Medicines Regulations 2013 (S.I. 2013/2033).</con

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-10-2"><num>(2)</num><intro>In making regulations under subsection (1), the appropriate authority's overarching objective must be to promote one or more of the following—</intro><level class="para1" eId="section-

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-10-2-a"><num>(a)</num><content>the health and welfare of animals;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-10-2-b"><num>(b)</num><content>the health and safety of the public;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-10-2-c"><num>(c)</num><content>the protection of the environment.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-10-3"><num>(3)</num><intro>In considering whether regulations under subsection (1) would contribute to this objective, the appropriate authority must have regard to—</intro><level class="para1" eId="section-10-3

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-10-3-a"><num>(a)</num><content>the safety of veterinary medicines;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-10-3-b"><num>(b)</num><content>the availability of veterinary medicines;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-10-3-c"><num>(c)</num><intro>the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to—</intro><level class="para2" eId="section-10-3-c-i"><num>(i)</num><con

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-10-3-c-i"><num>(i)</num><content>develop veterinary medicines, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-10-3-c-ii"><num>(ii)</num><content>manufacture or supply veterinary medicines.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-10-4"><num>(4)</num><content>Where regulations under subsection (1) may have an impact on the safety of veterinary medicines, the appropriate authority may make the regulations only if the authority considers that t

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-10-5"><num>(5)</num><intro>In subsection (3)(c), “<term refersTo="#term-relevant-part-of-the-united-kingdom" eId="term-relevant-part-of-the-united-kingdom">relevant part of the United Kingdom</term>” means—</in

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-10-5-a"><num>(a)</num><content>so far as the regulations relate to England and Wales and Scotland, those parts of the United Kingdom, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-10-5-b"><num>(b)</num><content>so far as the regulations relate to Northern Ireland, that part of the United Kingdom.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-10-6"><num>(6)</num><intro>In this Part, “<term refersTo="#term-appropriate-authority" eId="term-appropriate-authority">appropriate authority</term>” means—</intro><level class="para1" eId="section-10-6-a"><num

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-10-6-a"><num>(a)</num><content>in relation to England and Wales and Scotland, the Secretary of State, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-10-6-b"><num>(b)</num><intro>in relation to Northern Ireland—</intro><level class="para2" eId="section-10-6-b-i"><num>(i)</num><content>the Department of Agriculture, Environment and Rural Affairs in

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-10-6-b-i"><num>(i)</num><content>the Department of Agriculture, Environment and Rural Affairs in Northern Ireland, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-10-6-b-ii"><num>(ii)</num><content>the Department of Agriculture, Environment and Rural Affairs in Northern Ireland and the Secretary of State acting jointly.</content></level>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-11"><num>11</num><heading>Manufacture, marketing, supply and field trials</heading><subsection eId="section-11-1"><num>(1)</num><intro>Regulations under section 10(1) may make provision about—</intro><level class="

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-11-1"><num>(1)</num><intro>Regulations under section 10(1) may make provision about—</intro><level class="para1" eId="section-11-1-a"><num>(a)</num><content>authorisations to manufacture veterinary medicines,

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-a"><num>(a)</num><content>authorisations to manufacture veterinary medicines,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-b"><num>(b)</num><content>authorisations to import veterinary medicines,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-c"><num>(c)</num><content>authorisations to distribute veterinary medicines by way of wholesale dealing,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-d"><num>(d)</num><content>marketing authorisations,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-e"><num>(e)</num><content>marketing, importing or distributing active substances,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-f"><num>(f)</num><content>the categories of person who may supply veterinary medicines,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-g"><num>(g)</num><content>requirements that must be met in relation to the supply of veterinary medicines,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-h"><num>(h)</num><content>the registration of persons who supply or offer to supply veterinary medicines by means of the internet,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-i"><num>(i)</num><content>the circumstances in which veterinary medicines may be administered,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-j"><num>(j)</num><content>notification and reporting requirements in relation to veterinary medicines (or things purporting to be veterinary medicines) that have been placed on the market,</content

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-k"><num>(k)</num><content>the labelling and packaging of veterinary medicines or the information that must be supplied with them or made available in relation to them,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-l"><num>(l)</num><content>advertising with regard to veterinary medicines, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-1-m"><num>(m)</num><content>animal test certificates granted under the Veterinary Medicines Regulations 2013 (S.I. 2013/2033) for research purposes.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-11-2"><num>(2)</num><intro>Regulations under section 10(1) may make provision corresponding or similar to provision in the following EU Regulations—</intro><level class="para1" eId="section-11-2-a"><num>(a)</num

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-2-a"><num>(a)</num><content>Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulati

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-11-2-b"><num>(b)</num><content>Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive <ref eId="c00004" href="http:

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-12"><num>12</num><heading>Fees, offences, powers of inspectors, costs</heading><subsection eId="section-12-1"><num>(1)</num><intro>Regulations under section 10(1) may make provision—</intro><level class="para1" eId

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-12-1"><num>(1)</num><intro>Regulations under section 10(1) may make provision—</intro><level class="para1" eId="section-12-1-a"><num>(a)</num><content>about the charging of fees in connection with the exercis

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-12-1-a"><num>(a)</num><content>about the charging of fees in connection with the exercise of a function conferred by a veterinary medicines provision,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-12-1-b"><num>(b)</num><content>creating a criminal offence of failing to comply with a provision made in the regulations,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-12-1-c"><num>(c)</num><content>applying powers of entry or other powers of an inspector in the Veterinary Medicines Regulations 2013 (S.I. 2013/2033) with or without modification in relation to a prohibitio

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-12-1-d"><num>(d)</num><content>about the recovery of costs incurred in the administration of improvement notices or seizure notices under the Veterinary Medicines Regulations 2013 (see regulations 38 and 41

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-12-2"><num>(2)</num><content>Regulations under section 10(1) may not provide for an offence to be punishable with a sentence of imprisonment of more than two years.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-12-3"><num>(3)</num><content>Regulations applying powers of entry in reliance on subsection (1)(c) may not confer a power of entry in respect of premises used wholly or mainly as a private dwelling unless those prem

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-12-4"><num>(4)</num><intro>In this section, “<term refersTo="#term-veterinary-medicines-provision" eId="term-veterinary-medicines-provision">veterinary medicines provision</term>” means a provision in—</intro><

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-12-4-a"><num>(a)</num><content>regulations under section 10(1), or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-12-4-b"><num>(b)</num><content>the Veterinary Medicines Regulations 2013.</content></level>

<chapter xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="part-3-chapter-2"><num>CHAPTER 2</num><heading>International agreements: disclosure of information</heading><section eId="section-13"><num>13</num><heading>Disclosure of information in accordance with international agreements</he

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-13"><num>13</num><heading>Disclosure of information in accordance with international agreements</heading><subsection eId="section-13-1"><num>(1)</num><content>This section applies to information which a relevant author

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-13-1"><num>(1)</num><content>This section applies to information which a relevant authority holds in connection with veterinary medicines.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-13-2"><num>(2)</num><intro>The relevant authority may disclose information to a relevant person outside the United Kingdom where—</intro><level class="para1" eId="section-13-2-a"><num>(a)</num><content>the di

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-13-2-a"><num>(a)</num><content>the disclosure is required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of veterinary medicines, and</content></

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-13-2-b"><num>(b)</num><content>the relevant authority considers that the disclosure is in the public interest.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-13-3"><num>(3)</num><intro>The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority—</intro><level class="para1" eId="section-13-3-a"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-13-3-a"><num>(a)</num><content>considers that it is necessary to do so for the purpose mentioned in that subsection, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-13-3-b"><num>(b)</num><content>is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-13-4"><num>(4)</num><intro>Except as provided by subsection (5), the disclosure of information in accordance with this section does not breach—</intro><level class="para1" eId="section-13-4-a"><num>(a)</num><con

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-13-4-a"><num>(a)</num><content>an obligation of confidence owed by the person making the disclosure, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-13-4-b"><num>(b)</num><content>any other restriction on the disclosure of the information (however imposed).</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-13-5"><num>(5)</num><intro>Nothing in this section authorises a disclosure of information which—</intro><level class="para1" eId="section-13-5-a"><num>(a)</num><content>contravenes the data protection legisla

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-13-5-a"><num>(a)</num><content>contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), or</content></le

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-13-5-b"><num>(b)</num><content>is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-13-6"><num>(6)</num><content>This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-13-7"><num>(7)</num><intro>In this section—</intro><hcontainer name="definition"><content>“<term refersTo="#term-commercially-sensitive-information" eId="term-commercially-sensitive-information">commercially

<chapter xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="part-3-chapter-3"><num>CHAPTER 3</num><heading>Interpretation etc</heading><section eId="section-14"><num>14</num><heading>Interpretation of Part 3 and supplementary provision</heading><subsection eId="section-14-1"><num>(1)</num

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-14"><num>14</num><heading>Interpretation of Part 3 and supplementary provision</heading><subsection eId="section-14-1"><num>(1)</num><intro>In this Part—</intro><hcontainer name="definition"><content>“<term refe

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-14-1"><num>(1)</num><intro>In this Part—</intro><hcontainer name="definition"><content>“<term refersTo="#term-active-substance" eId="term-active-substance">active substance</term>” means any substance or mixt

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content>“<term refersTo="#term-forfeiture-order" eId="term-forfeiture-order">forfeiture order</term>” has the meaning given by section 32(1);</content></hcontainer>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-14-2"><num>(2)</num><content><mod>In the Animals (Scientific Procedures) Act 1986, in section 2 (regulated procedures), in subsection (8)(d), after “the Veterinary Medicines Regulations 2011” insert <quotedText>“

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:default="http://www.w3.org/1999/xhtml" eId="part-4"><num>PART 4</num><heading>Medical devices</head

<chapter xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="part-4-chapter-1"><num>CHAPTER 1</num><heading>Regulations: general</heading><section eId="section-15"><

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-15"><num>15</num><heading>Power to make regulations about medical devices</heading><subsection eId="section-15-1"><num>(1)</num><content>The Secretary of State may by regulations make provision specified in sections 16

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-15-1"><num>(1)</num><content>The Secretary of State may by regulations make provision specified in sections 16 to 18 amending or supplementing the Medical Devices Regulations 2002 (S.I. 2002/618).</content></sub

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-15-2"><num>(2)</num><content>In making regulations under subsection (1), the Secretary of State's overarching objective must be safeguarding public health.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-15-3"><num>(3)</num><intro>In considering whether regulations under subsection (1) would contribute to this objective, the Secretary of State must have regard to—</intro><level class="para1" eId="section-15-3-a"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-15-3-a"><num>(a)</num><content>the safety of medical devices;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-15-3-b"><num>(b)</num><content>the availability of medical devices;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-15-3-c"><num>(c)</num><intro>the likelihood of the United Kingdom being seen as a favourable place in which to—</intro><level class="para2" eId="section-15-3-c-i"><num>(i)</num><content>carry out res

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-15-3-c-i"><num>(i)</num><content>carry out research relating to medical devices,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-15-3-c-ii"><num>(ii)</num><content>develop medical devices, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-15-3-c-iii"><num>(iii)</num><content>manufacture or supply medical devices.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-15-4"><num>(4)</num><content>Where regulations under subsection (1) may have an impact on the safety of medical devices, the Secretary of State may make the regulations only if the Secretary of State considers that

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-16"><num>16</num><heading>Manufacture, marketing and supply</heading><subsection eId="section-16-1"><num>(1)</num><intro>Regulations under section 15(1) may make provision about—</intro><level class="para1" eId="se

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-16-1"><num>(1)</num><intro>Regulations under section 15(1) may make provision about—</intro><level class="para1" eId="section-16-1-a"><num>(a)</num><intro>requirements that must be met in relation to medical

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-16-1-a"><num>(a)</num><intro>requirements that must be met in relation to medical devices in order for them to be marketed, put into service or otherwise supplied (“relevant requirements”), including—</

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-16-1-a-i"><num>(i)</num><content>requirements in terms of design, manufacture, composition or other characteristics of the devices, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-16-1-a-ii"><num>(ii)</num><content>requirements imposed on persons involved in marketing or supplying the devices,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-16-1-b"><num>(b)</num><content>assessments of whether relevant requirements are met in relation to medical devices,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-16-1-c"><num>(c)</num><intro>who may carry out such assessments, including provision about the appointment of one or more persons (whether or not established in the United Kingdom) who meet criteria set out

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-16-1-c-i"><num>(i)</num><content>to assess whether relevant requirements are met, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-16-1-c-ii"><num>(ii)</num><content>if appropriate, to confirm that they are,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-16-1-d"><num>(d)</num><content>treating confirmation that relevant requirements are met given by one or more persons who are not appointed under provision made in reliance on paragraph (c) in the same way a

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-16-1-e"><num>(e)</num><content>the making of declarations confirming that relevant requirements are met,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-16-1-f"><num>(f)</num><content>requirements that medical devices carry evidence that relevant requirements are met, including evidence that confirmation has been given as mentioned in paragraph (c) or (d),<

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-16-1-g"><num>(g)</num><content>the packaging of medical devices, and information, labelling or instructions to be supplied on, with or in relation to them,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-16-1-h"><num>(h)</num><intro>one or more registers of medical devices, their manufacturers or their suppliers, including provision—</intro><level class="para2" eId="section-16-1-h-i"><num>(i)</num><cont

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-16-1-h-i"><num>(i)</num><content>conferring functions relating to establishing and maintaining a register,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-16-1-h-ii"><num>(ii)</num><content>requiring information in relation to a medical device to be entered in a register, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-16-1-h-iii"><num>(iii)</num><content>permitting or requiring some or all of the information entered in a register to be made publicly available,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-16-1-i"><num>(i)</num><content>investigations into or evaluations of the safety or performance, including the clinical effectiveness, of medical devices, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-16-1-j"><num>(j)</num><content>surveillance of the market in medical devices.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-16-2"><num>(2)</num><content>Provision made in reliance on subsection (1)(a) may (among other things) identify relevant requirements by reference to international agreements or standards relating to the marketing or

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-17"><num>17</num><heading>Fees, information, offences</heading><subsection eId="section-17-1"><n

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-17-1"><num>(1)</num><intro>Regulations under section 15(1) may make provision—</intro><level class="para1" eId="section-17-1-a"><num>(a)</num><content>about the charging of fees in connection with the exercis

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-17-1-a"><num>(a)</num><content>about the charging of fees in connection with the exercise of a function conferred by a medical devices provision, including the charging of fees by a person appointed under p

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-17-1-b"><num>(b)</num><content>about the recording of information regarding the safety and performance, including the clinical effectiveness, of medical devices, including the extent to which relevant requi

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-17-1-c"><num>(c)</num><content>permitting or requiring such information to be disclosed to the Secretary of State or to a person appointed under provision made in reliance on section 16(1)(c), or</conte

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-17-1-d"><num>(d)</num><content>amending the Schedule to the Medical Devices Regulations 2002 (S.I. 2002/618) inserted by Schedule 3 to this Act (list of regulations breach of which is an offence under regul

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-17-2"><num>(2)</num><intro>In <ins class="substitution first last" ukl:ChangeId="key-20c1

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-17-2-a"><num>(a)</num><content>regulations under section 15(1), or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-17-2-b"><num>(b)</num><content>the Medical Devices Regulations 2002.</content></level>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-18"><num>18</num><heading>Emergencies</heading><subsection eId="section-18-1"><num>(1)</num><content>Regulations under section 15(1) may make provision about the disapplication of a medical devices provision in circums

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-18-1"><num>(1)</num><content>Regulations under section 15(1) may make provision about the disapplication of a medical devices provision in circumstances which give rise to a need to protect the public from a risk of

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-18-2"><num>(2)</num><intro>Regulations made in reliance on subsection (1) may provide for the disapplication to be subject to—</intro><level class="para1" eId="section-18-2-a"><num>(a)</num><content>condition

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-18-2-a"><num>(a)</num><content>conditions set out in the regulations;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-18-2-b"><num>(b)</num><content>conditions set out in a protocol published by the Secretary of State.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-18-3"><num>(3)</num><intro>Where regulations made in reliance on subsection (1) provide that the Secretary of State may publish a protocol setting out conditions, the regulations must provide—</intro><level clas

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-18-3-a"><num>(a)</num><content>that the Secretary of State may withdraw or amend the protocol, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-18-3-b"><num>(b)</num><content>that the protocol is to have effect only for a period of time specified in the protocol.</content></level>

<chapter xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="part-4-chapter-2"><num>CHAPTER 2</num><heading>Regulations: information systems, advisory committee</hea

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-19"><num>19</num><heading>Information systems</heading><subsection eId="section-19-1"><num>(1)</

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-19-1"><num>(1)</num><intro>The Secretary of State may by regulations make provision about

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-19-1-a"><num>(a)</num><content>the safety and performance, including the clinical effectiveness, of medical devices that are placed on the market;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-19-1-b"><num>(b)</num><content>the safety of individuals who receive or are treated with a medical device, or into whom a medical device is implanted;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-19-1-c"><num>(c)</num><content>the improvement of medical device safety and performance through advances in technology.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-19-2"><num>(2)</num><intro>The regulations may (among other things) make provision—</i

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-19-2-a"><num>(a)</num><content>specifying descriptions of information in relation to medical devices which may or must be entered or retained in an information system established under subsection (1);</

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-19-2-b"><num>(b)</num><content>requiring information to be provided to <ins clas

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-19-2-c"><num>(c)</num><content>about the use or disclosure of information contained in an information system established under subsection (1);</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-19-2-d"><num>(d)</num><content>requiring <ins class="substitution first last" uk

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-19-3"><num>(3)</num><intro>The provision mentioned in subsection (2)(b) may include provis

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-19-3-a"><num>(a)</num><content>requiring specified persons or descriptions of per

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-19-3-b"><num>(b)</num><content>about the manner in which, and the time at which, those persons must provide that information;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-19-3-c"><num>(c)</num><intro>enabling <ins class="substitution first last" ukl:C

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-19-3-c-i"><num>(i)</num><content>information of a specified description;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-19-3-c-ii"><num>(ii)</num><content>information for specified purposes;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para2" eId="section-19-3-c-iii"><num>(iii)</num><content>any other information that <ins class="subs

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-19-3-d"><num>(d)</num><content>about any procedural steps <ins class="substituti

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-19-3-e"><num>(e)</num><content>requiring specified persons or descriptions of per

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-19-3-f"><num>(f)</num><content>in relation to the enforcement of any requirement imposed by or under the regulations.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-19-4"><num>(4)</num><content>This subsection applies to any person who provides services, or exercises any powers or duties, relating to medical devices.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-19-5"><num>(5)</num><intro>The descriptions of information specified in the provision mentioned in subsections (2)(a), (3)(a) and (3)(c)(i) may include—</intro><level class="para1" eId="section-19-5-a"><num>(a)<

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-19-5-a"><num>(a)</num><content>unique identifiers associated with medical devices;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-19-5-b"><num>(b)</num><content>information in relation to individuals mentioned in subsection (1)(b);</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-19-5-c"><num>(c)</num><content>information about any procedure carried out in relation to a medical device (including information about any person involved in carrying out the procedure).</content></lev

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-19-6"><num>(6)</num><intro>The provision mentioned in subsection (2)(c) may include provis

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-19-6-a"><num>(a)</num><content>the analysis by <ins class="substitution first la

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-19-6-b"><num>(b)</num><content>the publication by <ins class="substitution first

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-19-6-c"><num>(c)</num><content>the disclosure (other than by way of publication)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-19-6-d"><num>(d)</num><content>the use or further disclosure by any person of information disclosed to them under the regulations.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-19-7"><num>(7)</num><content>The provision mentioned in subsection (3)(f) may include provision applying any provision of Chapter 3 of this Part (enforcement), with or without modifications, in relation to a require

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-19-8"><num>(8)</num><content>In this section, “<term refersTo="#term-specified" eId="term-specified">specified</term>” means specified in regulations under subsection (1).</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-19-7A"><num><ins class="first" ukl:ChangeId="key-9d50bda95ccb77617c468fa7021149ee-16643631970

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-19-7A-a"><num><ins ukl:ChangeId="key-9d50bda95ccb77617c468fa7021149ee-1664363197076" ukl:CommentaryRef="key-9d50bda95ccb77617c468fa7021149ee">(a

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-19-7A-b"><num><ins ukl:ChangeId="key-9d50bda95ccb77617c468fa7021149ee-1664363197076" ukl:CommentaryRef="key-9d50bda95ccb77617c468fa7021149ee">(b

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-20"><num>20</num><heading>Advisory committee</heading><subsection eId="section-20-1"><num>(1)</num><content>The Secretary of State may by regulations establish, and make other provision about, a committee to advise the

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-20-1"><num>(1)</num><content>The Secretary of State may by regulations establish, and make other provision about, a committee to advise the Secretary of State on such matters relating to medical devices as the regul

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-20-2"><num>(2)</num><intro>The regulations may (among other things) make provision about—</intro><level class="para1" eId="section-20-2-a"><num>(a)</num><content>the membership of the committee;</content>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-20-2-a"><num>(a)</num><content>the membership of the committee;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-20-2-b"><num>(b)</num><content>the establishment by the committee of sub-committees;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-20-2-c"><num>(c)</num><content>matters to which the committee may, or must, have regard;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-20-2-d"><num>(d)</num><content>cooperation between the committee and the Commission on Human Medicines, and other bodies with expertise in relation to medical devices.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-20-3"><num>(3)</num><intro>The provision mentioned in subsection (2)(a) may include—</intro><level class="para1" eId="section-20-3-a"><num>(a)</num><content>provision about the number of members, their appoin

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-20-3-a"><num>(a)</num><content>provision about the number of members, their appointment, and the circumstances in which a person ceases to be a member;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-20-3-b"><num>(b)</num><content>requirements as to the independence of members from the Secretary of State;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-20-3-c"><num>(c)</num><content>provision about the payment of remuneration and allowances to members.</content></level>

<chapter xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="part-4-chapter-3"><num>CHAPTER 3</num><heading>Enforcement</heading><hcontainer name="crossheading" ukl:

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-21"><num>21</num><heading>Compliance notices</heading><subsection eId="section-21-1"><num>(1)</n

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-21-1"><num>(1)</num><content>This section applies where the enforcement authority has reasonable grounds to suspect that a person involved in marketing or supplying a medical device is not complying with a medical d

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-21-2"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(2)</ins></num

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-21-2-a"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(a)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-21-2-b"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(b)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-21-2-c"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(c)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-21-2-d"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(d)

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-21-2-e"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(e)

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-21-1A"><num><ins class="first" ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-16318737738

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-21-1A-a"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(a

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-21-1A-b"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(b

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-21-1A-c"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(c

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-21-1A-d"><num><ins class="substitution first" ukl:ChangeId="key-e0165180624c7b0dbdbb

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-21-3"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(3)</ins></num

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-21-4"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(4)</ins></num

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-21-5"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(5)</ins></num

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-21-6"><num><ins ukl:ChangeId="key-9fad5804e85e980cab776bc6cf66efd9-1631873773873" ukl:CommentaryRef="key-9fad5804e85e980cab776bc6cf66efd9">(6)</ins></num

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-22"><num>22</num><heading>Suspension notices</heading><subsection eId="section-22-1"><num>(1)</num><content>This section applies where the enforcement authority considers that it may be necessary to restrict the availa

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-22-1"><num>(1)</num><content>This section applies where the enforcement authority considers that it may be necessary to restrict the availability of a medical device in order to protect health or safety.</conten

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-22-2"><num>(2)</num><intro>The enforcement authority may serve on a person a notice (“a suspension notice”) prohibiting the person from doing the following except with the consent of the enforcement authority—</

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-22-2-a"><num>(a)</num><content>supplying the medical device;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-22-2-b"><num>(b)</num><content>offering to supply it;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-22-2-c"><num>(c)</num><content>agreeing to supply it;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-22-2-d"><num>(d)</num><content>exposing it for supply;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-22-2-e"><num>(e)</num><content>possessing it for supply.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-22-3"><num>(3)</num><intro>A suspension notice must—</intro><level class="para1" eId="section-22-3-a"><num>(a)</num><content>set out the enforcement authority's grounds for considering that it may be necessar

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-22-3-a"><num>(a)</num><content>set out the enforcement authority's grounds for considering that it may be necessary to restrict the availability of the medical device to which the notice relates, and</c

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-22-3-b"><num>(b)</num><content>specify the period for which the notice has effect.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-22-4"><num>(4)</num><content>The period may not end more than 6 months after the day on which the suspension notice is served.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-22-5"><num>(5)</num><intro>The enforcement authority may—</intro><level class="para1" eId="section-22-5-a"><num>(a)</num><content>reduce the period for which a suspension notice has effect, or</content></

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-22-5-a"><num>(a)</num><content>reduce the period for which a suspension notice has effect, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-22-5-b"><num>(b)</num><content>revoke a suspension notice.</content></level>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-23"><num>23</num><heading>Safety notices</heading><subsection eId="section-23-1"><num>(1)</num><content>The enforcement authority may serve on a person a notice (“a safety notice”) imposing on the person prohibitions o

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-23-1"><num>(1)</num><content>The enforcement authority may serve on a person a notice (“a safety notice”) imposing on the person prohibitions or requirements that the enforcement authority considers necessary to res

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-23-2"><num>(2)</num><intro>The prohibitions that may be imposed include prohibitions on doing any of the following except with the consent of the enforcement authority—</intro><level class="para1" eId="section-2

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-23-2-a"><num>(a)</num><content>supplying the medical device;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-23-2-b"><num>(b)</num><content>offering to supply it;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-23-2-c"><num>(c)</num><content>agreeing to supply it;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-23-2-d"><num>(d)</num><content>exposing it for supply;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-23-2-e"><num>(e)</num><content>possessing it for supply.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-23-3"><num>(3)</num><intro>The requirements that may be imposed include requirements to—</intro><level class="para1" eId="section-23-3-a"><num>(a)</num><content>publish, at the person's expense, one or more w

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-23-3-a"><num>(a)</num><content>publish, at the person's expense, one or more warnings, in such form and manner and on such occasions as may be specified in the notice, about a medical device which the perso

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-23-3-b"><num>(b)</num><content>organise or cooperate with the enforcement authority in organising in such manner as may be specified in the notice, so far as reasonably practicable, the recall of the device

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-23-4"><num>(4)</num><content>But a requirement to organise or cooperate in the recall of a device may be imposed on a person in reliance on subsection (3)(b) only if the enforcement authority is satisfied that no al

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-23-5"><num>(5)</num><content>A safety notice must set out the grounds on which the enforcement authority considers it necessary to restrict the availability of the medical device to which the notice relates.</co

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-23-6"><num>(6)</num><content>The enforcement authority may vary or revoke a safety notice.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-23-7"><num>(7)</num><content>Subject to subsection (8), the enforcement authority may not serve a safety notice on a person or vary a safety notice unless the enforcement authority has given the person a reasonable

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-23-8"><num>(8)</num><content>Subsection (7) does not apply where the enforcement authority considers that there is an urgent need to make the proposed safety notice or variation in order to restrict the availability

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-24"><num>24</num><heading>Information notices</heading><subsection eId="section-24-1"><num>(1)</num><intro>This section applies where the enforcement authority considers that a person has information which the enforcem

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-24-1"><num>(1)</num><intro>This section applies where the enforcement authority considers that a person has information which the enforcement authority needs for the purpose of deciding whether to—</intro><level

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-24-1-a"><num>(a)</num><content>serve or revoke a compliance notice,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-24-1-b"><num>(b)</num><content>serve or revoke a suspension notice, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-24-1-c"><num>(c)</num><content>serve, vary or revoke a safety notice.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-24-2"><num>(2)</num><intro>The enforcement authority may serve on the person a notice (an “information notice”) requiring the person—</intro><level class="para1" eId="section-24-2-a"><num>(a)</num><content>t

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-24-2-a"><num>(a)</num><content>to disclose to the enforcement authority information specified in the notice, within a period specified in the notice, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-24-2-b"><num>(b)</num><content>to produce records specified in the notice at a time and place specified in the notice, and to permit a person appointed by the enforcement authority to take copies of the rec

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-24-3"><num>(3)</num><content>A period specified in reliance on subsection (2)(a) must be a period of at least 28 days beginning with the day on which the notice is served.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-24-4"><num>(4)</num><content>A time specified in reliance on subsection (2)(b) must be at least 28 days after the notice is served.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-24-5"><num>(5)</num><content>The enforcement authority may vary or revoke an information notice.</content></subsection>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-25"><num>25</num><heading>Applications to set notices aside etc</heading><subsection eId="section-25-1"><num>(1)</num><intro>A person affected by a compliance, suspension or safety notice may apply to the appropriate l

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-25-1"><num>(1)</num><intro>A person affected by a compliance, suspension or safety notice may apply to the appropriate lower court (see section 42)—</intro><level class="para1" eId="section-25-1-a"><num>(a)</num

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-25-1-a"><num>(a)</num><content>to set the notice aside, or</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-25-2"><num>(2)</num><intro>A person on whom an information notice has been served may apply to the appropriate lower court—</intro><level class="para1" eId="section-25-2-a"><num>(a)</num><content>to set the n

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-25-2-a"><num>(a)</num><content>to set the notice aside, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-25-2-b"><num>(b)</num><content>to vary it as mentioned in subsection (8).</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-25-3"><num>(3)</num><intro>An application under subsection (1) or (2) must be made within the period of 28 days beginning with the day on which the notice to which it relates is—</intro><level class="para1" eId=

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-25-3-a"><num>(a)</num><content>served, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-25-3-b"><num>(b)</num><content>varied by the enforcement authority.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-25-4"><num>(4)</num><intro>The appropriate lower court may set aside a compliance, suspension, safety or information notice only if satisfied—</intro><level class="para1" eId="section-25-4-a"><num>(a)</num><cont

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-25-4-a"><num>(a)</num><content>in respect of a compliance notice, that the person on whom the notice was served is complying with each medical devices provision with which the person was suspected not to be

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-25-4-b"><num>(b)</num><content>in respect of a suspension notice, that the notice is not necessary to protect health or safety,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-25-4-c"><num>(c)</num><content>in respect of a safety notice, that the prohibitions or requirements in the notice are not necessary to protect health or safety, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-25-4-d"><num>(d)</num><content>in respect of an information notice, that the person on whom it has been served does not have the information or records specified in the notice.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-25-5"><num>(5)</num><content>The appropriate lower court may vary a compliance notice so that it does not apply in relation to a medical devices provision specified in the notice if satisfied that the person on whom

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-25-6"><num>(6)</num><content>The appropriate lower court may vary a suspension notice by reducing the period for which it is to have effect if satisfied that the period for which it would otherwise have had effect w

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-25-7"><num>(7)</num><content>The appropriate lower court may vary a safety notice by removing a prohibition or requirement if satisfied that the prohibition or requirement is not necessary to protect health or safet

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-25-8"><num>(8)</num><content>The appropriate lower court may vary an information notice so that it does not apply in relation to some of the information or records specified in the notice if satisfied that the perso

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-25-9"><num>(9)</num><content>An order of the appropriate lower court varying or setting aside a compliance, suspension, safety or information notice may contain provision delaying the coming into force of the order

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-26"><num>26</num><heading>Compensation</heading><subsection eId="section-26-1"><num>(1)</num><content>A person affected by a compliance, suspension or safety notice which the appropriate lower court varies or sets asid

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-26-1"><num>(1)</num><content>A person affected by a compliance, suspension or safety notice which the appropriate lower court varies or sets aside may apply to the appropriate lower court for an order requiring the

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-26-2"><num>(2)</num><content>An application under subsection (1) may be made at the same time as an application under section 25(1).</content></subsection>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-27"><num>27</num><heading>Further appeals</heading><subsection eId="section-27-1"><num>(1)</num><content>A person aggrieved by a decision of the appropriate lower court on an application under section 25(1) or (2) or s

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-27-1"><num>(1)</num><content>A person aggrieved by a decision of the appropriate lower court on an application under section 25(1) or (2) or section 26(1) may appeal against that decision to the appropriate appeals

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-27-2"><num>(2)</num><content>An appeal under subsection (1) must be made before the end of the period of 28 days beginning with the day on which the decision to which it relates is made.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-27-3"><num>(3)</num><content>The appropriate appeals court may make any order the court thinks appropriate.</content></subsection>

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="part-4-chapter-3-crossheading-offences"><heading>Offences</heading><section eId="section-28"><num>28</num><heading>O

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-28"><num>28</num><heading>Offences</heading><subsection eId="section-28-1"><num>(1)</num><intro>A person commits an offence if the person breaches—</intro><level class="para1" eId="section-28-1-a"><num>(a)</num><co

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-28-1"><num>(1)</num><intro>A person commits an offence if the person breaches—</intro><level class="para1" eId="section-28-1-a"><num>(a)</num><content>a compliance notice,</content></level><level class="p

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-28-1-a"><num>(a)</num><content>a compliance notice,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-28-1-b"><num>(b)</num><content>a suspension notice,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-28-1-c"><num>(c)</num><content>a safety notice, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-28-1-d"><num>(d)</num><content>an information notice.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-28-2"><num>(2)</num><intro>A person guilty of an offence under subsection (1) is liable—</intro><level class="para1" eId="section-28-2-a"><num>(a)</num><content>on summary conviction in England and Wales, to

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-28-2-a"><num>(a)</num><content>on summary conviction in England and Wales, to imprisonment for a term not exceeding 51 weeks, to a fine or to both;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-28-2-b"><num>(b)</num><content>on summary conviction in Scotland or Northern Ireland, to imprisonment for a term not exceeding 6 months, to a fine not exceeding level 5 on the standard scale or to both.

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-28-3"><num>(3)</num><content>In relation to an offence committed before the coming into force of section 281(5) of the Criminal Justice Act 2003, the reference in subsection (2)(a) to 51 weeks is to be read as a ref

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-29"><num>29</num><heading>Defence of due diligence</heading><subsection eId="section-29-1"><num>(1)</num><content>It is a defence for a person charged with an offence under section 28(1) to show that the person took al

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-29-1"><num>(1)</num><content>It is a defence for a person charged with an offence under section 28(1) to show that the person took all reasonable steps and exercised all due diligence to avoid commission of the offe

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-29-2"><num>(2)</num><intro>If in any proceedings for such an offence the defence provided by subsection (1) involves an allegation that the commission of the offence was due to—</intro><level class="para1" eId="

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-29-2-a"><num>(a)</num><content>an act or default of another person, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-29-2-b"><num>(b)</num><content>reliance on information given by another person,</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-29-3"><num>(3)</num><content>The requirement is that at least 7 clear days before the hearing of the proceedings the defendant has served on the prosecutor a notice giving such information identifying or assisting i

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-29-4"><num>(4)</num><intro>A defendant is not entitled to rely on the defence provided by subsection (1) by reason of the defendant's reliance on information supplied by another person unless the defendant shows tha

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-29-4-a"><num>(a)</num><content>the steps which the defendant took or might reasonably have taken to verify the information, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-29-4-b"><num>(b)</num><content>whether the defendant had any reason to disbelieve the information.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-29-5"><num>(5)</num><intro>In the application of this section to Scotland—</intro><level class="para1" eId="section-29-5-a"><num>(a)</num><content>references to the defendant are to be read as references to t

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-29-5-a"><num>(a)</num><content>references to the defendant are to be read as references to the accused, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-29-5-b"><num>(b)</num><content>the reference in subsection (3) to “the hearing of the proceedings” is to be read as a reference to “the trial diet”.</content></level>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-30"><num>30</num><heading>Offences by bodies corporate</heading><subsection eId="section-30-1"><num>(1)</num><content>Where an offence under section 28 committed by a body corporate or a Scottish partnership is proved

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-30-1"><num>(1)</num><content>Where an offence under section 28 committed by a body corporate or a Scottish partnership is proved to have been committed with the consent or connivance of, or to be attributable to any

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-30-2"><num>(2)</num><intro>In relation to a body corporate, “<term refersTo="#term-officer" eId="term-officer">officer</term>” means—</intro><level class="para1" eId="section-30-2-a"><num>(a)</num><content>a

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-30-2-a"><num>(a)</num><content>a director, manager, secretary or other similar officer of the body, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-30-2-b"><num>(b)</num><content>a person purporting to act in any such capacity.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-30-3"><num>(3)</num><content>In subsection (2)(a), “<term refersTo="#term-director" eId="term-director">director</term>”, in relation to a body corporate whose affairs are managed by its members, means a member of

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-30-4"><num>(4)</num><intro>In relation to a Scottish partnership, “<term refersTo="#term-officer" eId="term-officer">officer</term>” means—</intro><level class="para1" eId="section-30-4-a"><num>(a)</num><conten

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-30-4-a"><num>(a)</num><content>a partner, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-30-4-b"><num>(b)</num><content>a person purporting to act as a partner.</content></level>

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="part-4-chapter-3-crossheading-civil-sanctions"><heading>Civil sanctions</heading><section eId="section-31"><num>31</

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-31"><num>31</num><heading>Civil sanctions</heading><content>Schedule 2 makes provision for and relating to civil sanctions in relation to the commission of offences to do with medical devices.</content></section>

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="part-4-chapter-3-crossheading-forfeiture"><heading>Forfeiture</heading><section eId="section-32"><num>32</num><headi

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-32"><num>32</num><heading>Forfeiture of medical devices</heading><subsection eId="section-32-1"><num>(1)</num><content>The enforcement authority may apply to the appropriate lower court (see section 42) for an order fo

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-32-1"><num>(1)</num><content>The enforcement authority may apply to the appropriate lower court (see section 42) for an order for the forfeiture of a medical device (a “forfeiture order”) on the grounds that there

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-32-2"><num>(2)</num><content>The appropriate lower court may make a forfeiture order if satisfied that there has been such a contravention.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-32-3"><num>(3)</num><content>The enforcement authority must make reasonable efforts to give notice of the application to every person who the enforcement authority thinks is or may be entitled to the device to which

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-32-4"><num>(4)</num><intro>Each person claiming to be entitled to the device may—</intro><level class="para1" eId="section-32-4-a"><num>(a)</num><content>appear at the hearing of the application, or</cont

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-32-4-a"><num>(a)</num><content>appear at the hearing of the application, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-32-4-b"><num>(b)</num><content>make written representations to the appropriate lower court in relation to the application.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-32-5"><num>(5)</num><content>If the appropriate lower court decides to make a forfeiture order, the court may include in the order provision that the device to which the order relates is not to be forfeited before t

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-32-6"><num>(6)</num><content>The enforcement authority may dispose of a forfeited device in whatever way the enforcement authority thinks appropriate.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-32-7"><num>(7)</num><content>But the enforcement authority may not dispose of a forfeited device before the appropriate time.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-32-8"><num>(8)</num><intro>In this section, the “appropriate time” is—</intro><level class="para1" eId="section-32-8-a"><num>(a)</num><content>the end of the period within which an appeal under section 33 ma

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-32-8-a"><num>(a)</num><content>the end of the period within which an appeal under section 33 may be made against the order, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-32-8-b"><num>(b)</num><content>if such an appeal is made, the end of the day on which the appeal is finally determined or otherwise disposed of.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-32-9"><num>(9)</num><intro>In this section, persons “entitled to a device” are—</intro><level class="para1" eId="section-32-9-a"><num>(a)</num><content>if the device has not been seized by the enforcement au

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-32-9-a"><num>(a)</num><content>if the device has not been seized by the enforcement authority, the person in possession of the device,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-32-9-b"><num>(b)</num><content>if the device has been seized, the person from whom it was seized, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-32-9-c"><num>(c)</num><content>if different, any person to whom it belongs.</content></level>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-33"><num>33</num><heading>Appeals against forfeiture decisions</heading><subsection eId="section-33-1"><num>(1)</num><content>A person claiming to be entitled to a medical device which is subject to a forfeiture order

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-33-1"><num>(1)</num><content>A person claiming to be entitled to a medical device which is subject to a forfeiture order may appeal against the decision to make the order.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-33-2"><num>(2)</num><content>The enforcement authority may appeal against a decision of the appropriate lower court to refuse an application for a forfeiture order.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-33-3"><num>(3)</num><content>An appeal under this section is to the appropriate appeals court (see section 42).</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-33-4"><num>(4)</num><intro>An appeal under this section must be made before the end of the period of 28 days beginning with the day on which—</intro><level class="para1" eId="section-33-4-a"><num>(a)</num><conte

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-33-4-a"><num>(a)</num><content>the forfeiture order is made, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-33-4-b"><num>(b)</num><content>the application for a forfeiture order is refused.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-33-5"><num>(5)</num><content>Subject to subsection (6), the court hearing the appeal may make any order the court thinks appropriate.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-33-6"><num>(6)</num><content>If an appeal against a decision to make a forfeiture order is allowed, the court must, if the device to which the order relates has already been forfeited, order it to be returned to a p

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-33-7"><num>(7)</num><intro>In this section, persons “entitled to a device” are—</intro><level class="para1" eId="section-33-7-a"><num>(a)</num><content>if the device has not been seized by the enforcement au

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-33-7-a"><num>(a)</num><content>if the device has not been seized by the enforcement authority, the person in possession of the device,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-33-7-b"><num>(b)</num><content>if the device has been seized, the person from whom it was seized, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-33-7-c"><num>(c)</num><content>if different, any person to whom it belongs.</content></level>

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" name="crossheading" ukl:Name="Pblock" eId="part-4-chapter-3-crossheading-recovery-of-expenses-of-enforceme

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-34"><num>34</num><heading>Recovery of expenses of enforcement</heading><subsection eId="section-

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-34-1"><num>(1)</num><intro>This section applies where a court—</intro><level class="pa

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-34-1-a"><num>(a)</num><intro>convicts a person of an <ins class="substitution fi

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para2" eId="section-34-1-a-i"><num><ins class="substitution" ukl:ChangeId="key-bec2110c253fa67f56c2c2958f5b78d5-1631873855111" ukl:CommentaryRef="key-bec2110c253fa6

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para2" eId="section-34-1-a-ii"><num><ins class="substitution" ukl:ChangeId="key-bec2110c253fa67f56c2c2958f5b78d5-1631873855111" ukl:CommentaryRef="key-bec2110c253fa

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para2" eId="section-34-1-a-iii"><num><ins class="substitution" ukl:ChangeId="key-bec2110c253fa67f56c2c2958f5b78d5-1631873855111" ukl:CommentaryRef="key-bec2110c253f

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-34-1-b"><num>(b)</num><content>makes a forfeiture order under section 32 or 33(5) in relation to a medical device.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-34-2"><num>(2)</num><intro>The court may (in addition to any other order it may make as to costs or expenses) order the person convicted or, as the case may be, a person from whom a device is seized or to whom it be

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-34-2-a"><num>(a)</num><content>in connection with any seizure or detention of the device by or on behalf of the authority, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-34-2-b"><num>(b)</num><content>in connection with giving effect to the forfeiture order.</content></level>

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="part-4-chapter-3-crossheading-recall-of-medical-device-by-enforcement-authority"><heading>Recall of medical device by en

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-35"><num>35</num><heading>Recall of medical device by enforcement authority</heading><subsection eId="section-35-1"><num>(1)</num><intro>This section applies where the enforcement authority considers that—</intro><

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-35-1"><num>(1)</num><intro>This section applies where the enforcement authority considers that—</intro><level class="para1" eId="section-35-1-a"><num>(a)</num><content>it is necessary to restrict the availabi

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-35-1-a"><num>(a)</num><content>it is necessary to restrict the availability of a medical device in order to protect health or safety, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-35-1-b"><num>(b)</num><content>the device has already been supplied or made available to members of the public.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-35-2"><num>(2)</num><content>The authority may take such steps as it considers necessary to organise the return of the device to the authority or to another person (whether or not it issues a safety notice under sec

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-35-3"><num>(3)</num><content>The authority may take steps in reliance on subsection (2) only if satisfied that no alternative steps that did not involve recalling the device would sufficiently protect health or safe

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="part-4-chapter-3-crossheading-power-of-officer-of-revenue-and-customs-to-detain-medical-device"><heading>Power of office

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-36"><num>36</num><heading>Power of officer of Revenue and Customs to detain medical device</heading><subsection eId="section-36-1"><num>(1)</num><intro>An officer of Revenue and Customs may seize an imported medical de

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-36-1"><num>(1)</num><intro>An officer of Revenue and Customs may seize an imported medical device and detain it for not more than two working days in order to facilitate the exercise by an enforcement authority or a

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-36-1-b"><num>(b)</num><content>a medical devices provision, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-36-1-c"><num>(c)</num><content>Schedule 5 to the Consumer Rights Act 2015.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-36-2"><num>(2)</num><content>A device seized and detained under this section must be dealt with during the period of its detention in such manner as the Commissioners for Her Majesty's Revenue and Customs may direct

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-36-3"><num>(3)</num><content>In subsection (1), the reference to two working days is a reference to a period of 48 hours calculated from the time when the device in question is seized but disregarding so much of any

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-37"><num>37</num><heading>Offence of obstructing an officer of Revenue and Customs</heading><subsection eId="section-37-1"><num>(1)</num><content>A person commits an offence if the person intentionally obstructs an off

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-37-1"><num>(1)</num><content>A person commits an offence if the person intentionally obstructs an officer of Revenue and Customs who is acting under section 36.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-37-2"><num>(2)</num><intro>A person guilty of an offence under subsection (1) is liable—</intro><level class="para1" eId="section-37-2-a"><num>(a)</num><content>on summary conviction in England and Wales, to

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-37-2-a"><num>(a)</num><content>on summary conviction in England and Wales, to imprisonment for a term not exceeding 51 weeks, to a fine or to both;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-37-2-b"><num>(b)</num><content>on summary conviction in Scotland or Northern Ireland, to imprisonment for a term not exceeding 6 months, to a fine not exceeding level 5 on the standard scale or to both.

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-37-3"><num>(3)</num><content>In relation to an offence committed before the coming into force of section 281(5) of the Criminal Justice Act 2003, the reference in subsection (2)(a) to 51 weeks is to be read as a ref

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" name="crossheading" ukl:Name="Pblock" eId="part-4-chapter-3-crossheading-civil-proceedings"><heading>Civil proceedings</heading><section eId="section-38"><num>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-38"><num>38</num><heading>Civil proceedings</heading><subsection eId="section-38-1"><num>(1)</num><content>An obligation imposed by a medical devices provision is to be treated as a duty owed to any person who may be a

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-38-1"><num>(1)</num><content>An obligation imposed by a medical devices provision is to be treated as a duty owed to any person who may be affected by a breach of the obligation.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-38-2"><num>(2)</num><content>Accordingly, a breach of such an obligation gives rise to a right of action for breach of statutory duty.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-38-3"><num>(3)</num><intro>Subsections (1) and (2) are subject to—</intro><level class="para1" eId="section-38-3-a"><num>(a)</num><content>a provision to the contrary in a medical devices provision, and</

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-38-3-a"><num>(a)</num><content>a provision to the contrary in a medical devices provision, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-38-3-b"><num>(b)</num><content>the defences and other incidents applying to actions for breach of statutory duty.</content></level>

<chapter xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:default="http://www.w3.org/1999/xhtml" eId="part-4-chapter-4"><num>CHAPTER 4</num><heading>Disclosure o

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" name="crossheading" ukl:Name="Pblock" eId="part-4-chapter-4-crossheading-disclosure-of-information"><headi

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-39"><num>39</num><heading>Disclosure of information</heading><subsection eId="section-39-1"><num

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-39-1"><num>(1)</num><content>This section applies in relation to information which the Secretary of State holds in connection with medical devices.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-39-2"><num>(2)</num><content>The Secretary of State may disclose information for the purpose of warning members of the public about concerns that the Secretary of State has in relation to the safety of a medical dev

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-39-3"><num>(3)</num><intro>The Secretary of State may disclose information to a person who provides services or exercises functions relating to medical devices for the purposes of—</intro><level class="para1" eI

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-3-a"><num>(a)</num><content>enabling or facilitating the exercise by the Secretary of State of a function relating to medical devices;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-3-b"><num>(b)</num><content>enabling or facilitating the exercise by another person of a function relating to medical devices;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-3-c"><num>(c)</num><content>enabling or facilitating the provision of a service relating to medical devices by another person.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-39-4"><num>(4)</num><intro>The Secretary of State may disclose information for the purposes of—</intro><level class="para1" eId="section-39-4-a"><num>(a)</num><content>civil proceedings;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-4-a"><num>(a)</num><content>civil proceedings;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-4-b"><num>(b)</num><content>criminal investigations or proceedings.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-39-5"><num>(5)</num><intro>The Secretary of State may disclose information to a relevant person outside the United Kingdom where—</intro><level class="para1" eId="section-39-5-a"><num>(a)</num><content>the di

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-5-a"><num>(a)</num><content>the disclosure is required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of medical devices, and</content></level

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-5-b"><num>(b)</num><content>the Secretary of State considers that the disclosure is in the public interest.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-39-6"><num>(6)</num><content>But subsection (5) does not authorise a disclosure of patient information without the consent of the individual to whom that information relates.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-39-7"><num>(7)</num><intro>The Secretary of State may not disclose commercially sensitive information in reliance on subsection (2), (3), (4) or (5) unless the Secretary of State—</intro><level class="para1" eId

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-7-a"><num>(a)</num><content>considers that it is necessary to do so for one or more of the purposes mentioned in subsection (2), (3), (4) or (5), and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-7-b"><num>(b)</num><content>is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-39-8"><num>(8)</num><intro>Where information to which this section applies is disclosed to a person in reliance on subsection (3) or (4), the person may not use or further disclose the information except—</intro

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-8-a"><num>(a)</num><content>with the agreement of the Secretary of State and for a purpose mentioned in subsection (3) or (4), or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-8-b"><num>(b)</num><content>in accordance with an enactment or order of a court or tribunal.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-39-9"><num>(9)</num><intro>Except as provided by subsection (10), the disclosure of information in accordance with this section does not breach—</intro><level class="para1" eId="section-39-9-a"><num>(a)</num><co

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-9-a"><num>(a)</num><content>an obligation of confidence owed by the person making the disclosure, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-39-9-b"><num>(b)</num><content>any other restriction on the disclosure of the information (however imposed).</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-39-10"><num>(10)</num><intro>Nothing in this section authorises a disclosure of informatio

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-39-10-a"><num>(a)</num><content>contravenes the data protection legislation (but

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-39-10-b"><num>(b)</num><content>is prohibited by any of Parts 1 to 7 or Chapter 1

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-39-10-c"><num><ins class="first" ukl:ChangeId="key-b3dcbfa485ba06a64adcccf2dfc15585-

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-39-11"><num>(11)</num><content>This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-39-12"><num>(12)</num><intro>In this section—</intro><hcontainer name="definition"><content>“<term refersTo="#term-commercially-sensitive-infor

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-40"><num>40</num><heading>Offences relating to information</heading><subsection eId="section-40-1"><num>(1)</num><content>A person to whom information is disclosed under section 39 commits an offence if the person uses

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-40-1"><num>(1)</num><content>A person to whom information is disclosed under section 39 commits an offence if the person uses or discloses that information in contravention of subsection (8) of that section.</co

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-40-2"><num>(2)</num><content>A person to whom information is disclosed under regulations under section 19 (information systems) commits an offence if the person uses or discloses that information in contravention of

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-40-3"><num>(3)</num><intro>A person guilty of an offence under subsection (1) or (2) is liable—</intro><level class="para1" eId="section-40-3-a"><num>(a)</num><content>on summary conviction in England and Wal

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-40-3-a"><num>(a)</num><content>on summary conviction in England and Wales, to imprisonment for a term not exceeding 51 weeks, to a fine or to both;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-40-3-b"><num>(b)</num><content>on summary conviction in Scotland or Northern Ireland, to imprisonment for a term not exceeding 6 months, to a fine not exceeding level 5 on the standard scale or to both.

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-40-4"><num>(4)</num><content>In relation to an offence committed before the coming into force of section 281(5) of the Criminal Justice Act 2003, the reference in subsection (3)(a) to 51 weeks is to be read as a ref

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:default="http://www.w3.org/1999/xhtml" name="crossheading" ukl:Name="Pblock" eId="part-4-chapter-4-c

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:default="http://www.w3.org/1999/xhtml" eId="section-41"><num>41</num><heading>Consequential and supplem

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-41-1"><num>(1)</num><intro>In the Consumer Protection Act 1987—</intro><level class="p

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-41-1-a"><num>(a)</num><content><mod>in section 11 (safety regulations), in subsec

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-41-1-b"><num>(b)</num><content><mod>in section 19 (interpretation of Part 2), in

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:default="http://www.w3.org/1999/xhtml" eId="section-41-2"><num>(2)</num><intro>In the Consumer Ri

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-41-2-a"><num>(a)</num><content><mod>in paragraph 10 (enforcer's legislation: duties and powers mentioned in paragraph 9(1)(a)), at the appropriate place insert <quotedText>“ regula

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-41-2-c"><num>(c)</num><content><mod>in paragraph 19 (exercise of powers in Part 4

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-41-2-d"><num>(d)</num><content><mod>after paragraph 30 insert—<quotedStructure st

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-41-2-e"><num>(e)</num><intro>in paragraph 31 (power to break open container etc)—</intro><level class="para2" eId="section-41-2-e-i"><num>(i)</num><content><mod>in sub-paragraph (1), for “30” substi

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-41-2-e-i"><num>(i)</num><content><mod>in sub-paragraph (1), for “30” substitute <quotedText>“ 30A ”</quotedText>;</mod></content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-41-2-e-ii"><num>(ii)</num><content><mod>in sub-paragraph (2), for “30” substitute <quotedText>“ 30A ”</quotedText>.</mod></content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-41-3"><num>(3)</num><content>The Medical Devices Regulations 2002 (S.I. 2002/618) are amended in accordance with subsections (4) to (7).</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-41-4"><num>(4)</num><content>In regulation 2 (interpretation), in paragraph (1) omit the definition of “the 1987 Act”.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-41-5"><num>(5)</num><content>Omit regulation 3B (confidentiality).</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-41-6"><num>(6)</num><content><mod>In regulation 61 (enforcement and the Consumer Protectio

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-41-7"><num>(7)</num><intro>Omit—</intro><level class="para1" eId="section-41-7-a"><num>(a)</num><content>regulation 62 (compliance notices),</content></level><level class="para1" eId="section-41-7-b"><num

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-41-7-a"><num>(a)</num><content>regulation 62 (compliance notices),</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-41-7-b"><num>(b)</num><content>regulation 63 (restriction notices), and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-41-7-c"><num>(c)</num><content>regulation 64 (notification of decisions etc).</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-41-8"><num>(8)</num><content>As a result of the amendments made by subsections (1), (4), (6) and (7), the Medical Devices Regulations 2002 are not to be recognised as safety regulations for the purposes of the Consu

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-41-9"><num>(9)</num><content>Schedule 3 makes it an offence to breach various provisions in the Medical Devices Regulations 2002.</content></subsection>

<chapter xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="part-4-chapter-5"><num>CHAPTER 5</num><heading>Interpretation of Part 4</heading><section eId="section-4

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-42"><num>42</num><heading>Interpretation of Part 4</heading><subsection eId="section-42-1"><num>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-42-1"><num>(1)</num><content>In this Part, apart from in sections 32, 33 and 34 (provisions relating to forfeiture or seizure of medical devices), references to a medical device include references to a type of medic

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-42-2"><num>(2)</num><intro>In this Part—</intro><hcontainer name="definition"><intro><

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:xhtml="http://www.w3.org/1999/xhtml" eId="part-5"><num>PART 5</num><heading>Regulations under Parts

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-43"><num>43</num><heading>Power to make consequential etc provision</heading><subsection eId="se

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-43-1"><num>(1)</num><content> <ins class="substitution first last" ukl:ChangeId="key-9f51c

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-43-2"><num>(2)</num><intro>The regulations may—</intro><level class="para1" eId="section-43-2-a"><num>(a)</num><content>make consequential, supplementary, incidental, transitional, transitory or saving provis

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-43-2-a"><num>(a)</num><content>make consequential, supplementary, incidental, transitional, transitory or saving provision;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-43-2-b"><num>(b)</num><content>make different provision for different purposes;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-43-2-c"><num>(c)</num><content>make different provision for different areas;</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-43-2-d"><num>(d)</num><content>make provision for all cases to which the power applies or for those cases subject to specified exceptions or for any specified cases or descriptions of case.</content></l

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-43-3"><num><ins class="first" ukl:ChangeId="key-796ebf58025096ae6df01c21892d6a8c-166436328607

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-43-3-a"><num><ins ukl:ChangeId="key-796ebf58025096ae6df01c21892d6a8c-1664363286073"

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-43-3-b"><num><ins ukl:ChangeId="key-796ebf58025096ae6df01c21892d6a8c-1664363286073" ukl:CommentaryRef="key-796ebf58025096ae6df01c21892d6a8c">(b)

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-44"><num>44</num><heading>Scope of powers of Northern Ireland departments</heading><intro>No

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-44-a"><num>(a)</num><content>would be within the legislative competence of the Assembly, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-44-b"><num>(b)</num><content>would not require the consent of the Secretary of State.</content></level>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-45"><num>45</num><heading>Consultation</heading><subsection eId="section-45-1"><num>(1)</num><co

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-45-1"><num>(1)</num><content>Before making regulations under a provision of Part 1, 2, 3 or 4, the relevant authority must carry out a public consultation.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-45-2"><num>(2)</num><intro>In relation to proposed regulations under section 19(1), the Secretary of State must specifically consult—</intro><level class="para1" eId="section-45-2-a"><num>(a)</num><content>th

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-45-2-a"><num>(a)</num><content>the Welsh Ministers,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-45-2-b"><num>(b)</num><content>the Scottish Ministers, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-45-2-c"><num>(c)</num><content>the Department of Health in Northern Ireland.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-45-1A"><num><ins class="first" ukl:ChangeId="key-82655a6d2f1bde4e65368c4933618a4c-16643635289

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-45-1A-a"><num><ins ukl:ChangeId="key-82655a6d2f1bde4e65368c4933618a4c-1664363528920" ukl:CommentaryRef="key-82655a6d2f1bde4e65368c4933618a4c">(a

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-45-1A-b"><num><ins ukl:ChangeId="key-82655a6d2f1bde4e65368c4933618a4c-1664363528920" ukl:CommentaryRef="key-82655a6d2f1bde4e65368c4933618a4c">(b

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-45-3"><num>(3)</num><content>In relation to proposed regulations under section 2(1), 10(1) or 15(1), the consultation document must include a summary of the relevant authority's assessment of the matters mentioned i

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-45-4"><num>(4)</num><intro>The duty to consult imposed by subsection (1) does not apply in relation to regulations that contain only provision made in reliance on—</intro><level class="para1" eId="section-45-4-a

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-45-4-a"><num>(a)</num><content>section 7 (disapplication of provisions relating to human medicines where there is a risk of serious harm to health), or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-45-4-b"><num>(b)</num><content>section 18 (disapplication of provisions relating to medical devices where there is a risk of serious harm to health),</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-45-5"><num>(5)</num><content>The duty to consult imposed by subsection (1) may be satisfied by consultation carried out before this Act was passed.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-45-6"><num>(6)</num><intro>In this section, “<term refersTo="#term-the-relevant-authority

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-45-6-a"><num><ins class="substitution first" ukl:ChangeId="key-9589fbbcf90852e0f9883

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-45-6-b"><num>(b)</num><content>in relation to any other regulations, the Secretary of State.</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-45-6-aa"><num><ins class="substitution" ukl:ChangeId="key-9589fbbcf90852e0f9883f4472e52440-1664363549052" ukl:CommentaryRef="key-9589fbbcf90852e

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-46"><num>46</num><heading>Reporting requirements</heading><subsection eId="section-46-1"><num>(1

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-46-1"><num>(1)</num><content>As soon as reasonably practicable after the end of each repor

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-46-2"><num>(2)</num><content>In preparing a report, the relevant authority must consult such persons as the relevant authority considers appropriate.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-46-3"><num>(3)</num><intro>A report must include a summary of—</intro><level class="pa

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-46-3-a"><num>(a)</num><content>any concerns raised, or proposals for change made, by a person consulted in accordance with subsection (2), and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-46-3-b"><num>(b)</num><content>the relevant authority's response to those concern

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-46-4"><num>(4)</num><intro>The reporting periods are—</intro><level class="para1" eId=

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" class="para1" eId="section-46-4-a"><num>(a)</num><content>the period of 24 months beginning with the day on

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-46-4-b"><num>(b)</num><content>each successive period of 24 months.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-46-5"><num>(5)</num><intro>In this section—</intro><hcontainer name="definition"><intr

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1"><num>(b)</num><content>a person who exercises functions on behalf of such a government;</content></level>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:xhtml="http://www.w3.org/1999/xhtml" eId="section-47"><num>47</num><heading>Procedure</heading><subsect

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-47-1"><num>(1)</num><content>Any power to make regulations under a provision of Part 1, 2, 3 or 4 so far as exercisable by the Secretary of State, or by the Secretary of State acting jointly with a Northern Ireland

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" eId="section-47-2"><num>(2)</num><content>Any power to make regulations under section 2(1) <ins class=

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:xhtml="http://www.w3.org/1999/xhtml" eId="section-47-3"><num>(3)</num><content>The procedure for making regulations under Part 1, 2, 3 or 4 is to be determin

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-47-4"><num>(4)</num><content>Provision that may be made by regulations subject to the negative procedure may be made by regulations subject to the draft affirmative procedure.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-47-5"><num>(5)</num><intro>Where regulations are subject to “the negative procedure”—</intro><level class="para1" eId="section-47-5-a"><num>(a)</num><content>in the case of regulations made by the Secretary

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-5-a"><num>(a)</num><content>in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations is subject to annulment in pursuance of a resolutio

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-5-b"><num>(b)</num><content>in the case of regulations made by a Northern Ireland department acting alone, they are subject to negative resolution within the meaning given by section 41(6) of the Interpr

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-5-c"><num>(c)</num><intro>in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations is subject to—</p

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-47-5-c-i"><num>(i)</num><content>annulment in pursuance of a resolution of either House of Parliament, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-47-5-c-ii"><num>(ii)</num><content>negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 1954.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-47-6"><num>(6)</num><intro>Where regulations are subject to the “draft affirmative procedure”—</intro><level class="para1" eId="section-47-6-a"><num>(a)</num><content>in the case of regulations made by the S

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-6-a"><num>(a)</num><content>in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations may not be made unless a draft of the instrument ha

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-6-b"><num>(b)</num><content>in the case of regulations made by a Northern Ireland department acting alone, they may not be made unless a draft of the regulations has been laid before and approved by a re

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-6-c"><num>(c)</num><intro>in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations may not be made u

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-47-6-c-i"><num>(i)</num><content>each House of Parliament, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-47-6-c-ii"><num>(ii)</num><content>the Northern Ireland Assembly.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-47-7"><num>(7)</num><intro>Where regulations are subject to the “made affirmative procedure”—</intro><level class="para1" eId="section-47-7-a"><num>(a)</num><intro>in the case of regulations made by the Secr

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-7-a"><num>(a)</num><intro>in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations—</intro><level class="para2" eId="section-47-7-a-

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-47-7-a-i"><num>(i)</num><content>must be laid before Parliament after being made, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-47-7-a-ii"><num>(ii)</num><content>ceases to have effect at the end of the period of 40 days beginning with the day on which the instrument is made unless, during that period, the instrument is approved by

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-7-b"><num>(b)</num><intro>in the case of regulations made by a Northern Ireland department acting alone, they—</intro><level class="para2" eId="section-47-7-b-i"><num>(i)</num><content>must be lai

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-47-7-b-i"><num>(i)</num><content>must be laid before the Northern Ireland Assembly after being made, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-47-7-b-ii"><num>(ii)</num><content>cease to have effect at the end of the period of 40 days beginning with the day on which they are made unless, during that period, the regulations are approved by a resolu

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-7-c"><num>(c)</num><intro>in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations—</intro><leve

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-47-7-c-i"><num>(i)</num><content>must be laid before Parliament and the Northern Ireland Assembly after being made, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para2" eId="section-47-7-c-ii"><num>(ii)</num><content>ceases to have effect at the end of the period of 40 days beginning with the day on which the instrument is made unless, during that period, the instrument is approved by

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-47-8"><num>(8)</num><intro>In calculating the period of 40 days for the purposes of subsection (7)(a)(ii) or (c)(ii) in relation to Parliament, no account is to be taken of any time during which—</intro><level c

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-8-a"><num>(a)</num><content>Parliament is dissolved or prorogued, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-8-b"><num>(b)</num><content>either House of Parliament is adjourned for more than 4 days.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-47-9"><num>(9)</num><intro>In calculating the period of 40 days for the purposes of subsection (7)(b)(ii) or (c)(ii) in relation to the Northern Ireland Assembly, no account is to be taken of any time during which t

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-9-a"><num>(a)</num><content>dissolved,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-9-b"><num>(b)</num><content>in recess for more than 4 days, or</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-9-c"><num>(c)</num><content>adjourned for more than 6 days.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-47-10"><num>(10)</num><intro>If regulations cease to have effect as a result of subsection (7) that—</intro><level class="para1" eId="section-47-10-a"><num>(a)</num><content>does not affect the validity of an

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-10-a"><num>(a)</num><content>does not affect the validity of anything previously done under the regulations, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-47-10-b"><num>(b)</num><content>does not prevent the making of new regulations.</content></level>

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="part-6"><num>PART 6</num><heading>Report on operation of medicines and medical devices legislation</heading><section eId="section-48"><num>48</num><heading>Report on operation of medicines and medical devices legislation</hea

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-48"><num>48</num><heading>Report on operation of medicines and medical devices legislation</heading><subsection eId="section-48-1"><num>(1)</num><content>The Secretary of State must, before the end of the relevant peri

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-48-1"><num>(1)</num><content>The Secretary of State must, before the end of the relevant period, publish a report on the operation of medicines and medical devices legislation.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-48-2"><num>(2)</num><intro>The report must, in particular, include an assessment of whether—</intro><level class="para1" eId="section-48-2-a"><num>(a)</num><content>some or all medicines and medical devices l

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-48-2-a"><num>(a)</num><content>some or all medicines and medical devices legislation should be consolidated or otherwise restructured,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-48-2-b"><num>(b)</num><content>provisions of medicines and medical devices legislation should be included in regulations or Acts of Parliament, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-48-2-c"><num>(c)</num><content>powers to make regulations should be modified or repealed.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-48-3"><num>(3)</num><content>In preparing the report, the Secretary of State must take into account any report relating to the operation of medicines and medical devices legislation made by a Parliamentary Committee

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-48-4"><num>(4)</num><content>The Secretary of State must lay a copy of the report before Parliament.</content></subsection>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-48-5"><num>(5)</num><intro>In this section—</intro><hcontainer name="definition"><intro>“<term refersTo="#term-medicines-and-medical-devices-legislation" eId="term-medicines-and-medical-devices-legislation">m

<part xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="part-7"><num>PART 7</num><heading>Extent, commencement and short title</heading><section eId="section-49"><num>49</num><heading>Extent</heading><content>This Act extends to England and Wales, Scotland and Northern Ireland.

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-49"><num>49</num><heading>Extent</heading><content>This Act extends to England and Wales, Scotland and Northern Ireland.</content></section>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-50"><num>50</num><heading>Commencement</heading><subsection eId="section-50-1"><num>(1)</num><intro>The following come into force on the day on which this Act is passed—</intro><level class="para1" eId="section-50-

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-50-1"><num>(1)</num><intro>The following come into force on the day on which this Act is passed—</intro><level class="para1" eId="section-50-1-a"><num>(a)</num><content>this Part,</content></level><level

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-50-1-b"><num>(b)</num><content>section 2,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-50-1-c"><num>(c)</num><content>section 6(4),</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-50-1-d"><num>(d)</num><content>section 7,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-50-1-e"><num>(e)</num><content>section 9,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-50-1-f"><num>(f)</num><content>section 15,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-50-1-g"><num>(g)</num><content>section 17(2),</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-50-1-h"><num>(h)</num><content>section 18,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-50-1-i"><num>(i)</num><content>section 42,</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-50-2"><num>(2)</num><intro>The following come into force at the end of the period of two months beginning with the day on which this Act is passed—</intro><level class="para1" eId="section-50-2-a"><num>(a)</num>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-50-2-b"><num>(b)</num><content>the remaining provisions of Part 2,</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-50-2-d"><num>(d)</num><content>the remaining provisions of Chapter 1 of Part 4, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-50-2-e"><num>(e)</num><content>Chapter 2 of Part 4.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-50-3"><num>(3)</num><content>Chapters 3 and 4 of Part 4 (medical devices: enforcement and disclosure of information) come into force on such day or days as the Secretary of State may by regulations made by statutory

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-50-4"><num>(4)</num><content>Regulations may not be made in reliance on section 7 or 18 that come into force before the end of the period of two months beginning with the day on which this Act is passed unless they

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-51"><num>51</num><heading>Transitional etc provision in connection with commencement</heading><subsection eId="section-51-1"><num>(1)</num><content>The Secretary of State may by regulations made by statutory instrument

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-51-1"><num>(1)</num><content>The Secretary of State may by regulations made by statutory instrument make transitional, transitory or saving provision in connection with the coming into force of any provision of this

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-51-2"><num>(2)</num><content>The relevant Northern Ireland department may by regulations make transitional, transitory or saving provision in connection with the coming into force of Part 2 or, as the case may be, P

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-51-3"><num>(3)</num><intro>No provision may be made by the relevant Northern Ireland department in regulations under subsection (2) unless the provision, if it were contained in an Act of the Northern Ireland Assemb

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-51-3-a"><num>(a)</num><content>would be within the legislative competence of the Assembly, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-51-3-b"><num>(b)</num><content>would not require the consent of the Secretary of State.</content></level>

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-51-4"><num>(4)</num><content>Regulations of the Secretary of State under this section may not contain provision that could be made by regulations of the relevant Northern Ireland department under this section.</

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-51-5"><num>(5)</num><content>The power to make regulations under subsection (2) is exercisable by statutory rule for the purposes of the Statutory Rules (Northern Ireland) Order 1979 (S.I. 1979/1573 (N.I. 12)).<

<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-51-6"><num>(6)</num><intro>In this section, the “<term refersTo="#term-relevant-northern-ireland-department" eId="term-relevant-northern-ireland-department">relevant Northern Ireland department</term>” means—</

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-51-6-a"><num>(a)</num><content>in relation to Part 2, the Department of Health in Northern Ireland, and</content></level>

<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-51-6-b"><num>(b)</num><content>in relation to Part 3, the Department of Agriculture, Environment and Rural Affairs in Northern Ireland.</content></level>

<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-52"><num>52</num><heading>Short title</heading><content>This Act may be cited as the Medicines and Medical Devices Act 2021.</content></section>

<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:default="http://www.w3.org/1999/xhtml" name="schedules" eId="schedules"><heading>SCHEDULES</heading>