LINDER v. SWEDEN

For the purposes of this Part of this Act the authority responsible for the grant, renewal, variation, suspension and revocation of licences and certificates shall be a body of Ministers consisting of all the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act.

Any function conferred on the licensing authority by or under this Act may be performed by any one of those Ministers acting alone or by any two or more of them acting jointly.

In accordance with the preceding provisions of this section, in this Act " the licensing authority " means any one or more of those Ministers, and, in the case of anything falling to be done by the licensing authority, means any one or more of those Ministers acting as mentioned in subsection (2) of this section.

The following provisions of this section shall have effect subject to—

Except in accordance with a licence granted for the purposes of this section (in this Act referred to as a " product licence ") no person shall, in the course of a business carried on by him, and in circumstances to which this subsection applies.—

No person shall import any medicinal product except in accordance with a product licence.

In relation to an imported medicinal product, subsection (2) of this section applies to circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or exportation or the manufacture or assembly for sale, supply or exportation of that product, has himself imported the product or procured its importation.

In relation to any medicinal product which has not been imported, subsection (2) of this section applies to any circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or exportation or the manufacture or assembly for sale, supply or exportation of that product, is responsible for the composition of the product.

For the purposes of subsection (5) of this section a person shall be taken to be responsible for the composition of a medicinal product if (but only if) in the course of a business carried on by him—

The following provisions of this section shall have effect without prejudice to the operation of section 7 of this Act, but subject to the exemptions and provisions referred to in paragraphs (a) to (c) of subsection (1) of that section.

No person shall, in the course of a business carried on by him, manufacture or assemble any medicinal product except in accordance with a licence granted for the purposes of this subsection (in this Act referred to as a " manufacturer's licence ").

No person shall, in the course of a business carried on by him, sell, or offer for sale, any medicinal product by way of wholesale dealing except in accordance with a licence granted for the purposes of this subsection (in this Act referred to as a " wholesale dealer's licence ").

The restrictions imposed by sections 7 and 8 of this Act do not apply to anything done by a doctor or dentist which—

Subject to subsection (3) of this section, the restrictions imposed by sections 7 and 8 of this Act do not apply to anything done by a veterinary surgeon or veterinary practitioner which—

The last preceding subsection shall not have effect so as to exempt from the restrictions imposed by sections 7 and 8 of this Act anything done by a veterinary surgeon or veterinary practitioner—

... The restrictions imposed by regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations do not apply to anything which is done in a registered pharmacy, a hospital , a care home service or a health centre and is done there by or under the supervision of a pharmacist and consists of—

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Those restrictions do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where—

Without prejudice to the preceding subsections, the restrictions imposed by regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of— and those restrictions do not apply to anything which is done in a hospital or a health centre by or under the supervision of a pharmacist and consists of preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) of this section.

Without prejudice to the preceding subsections, the restrictions imposed by regulation 46 of the 2012 Regulations do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist where—

Without prejudice to the preceding subsections, the restrictions imposed by regulation 17(1) of the 2012 Regulations do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of preparing a medicinal product with a view to retail sale or to supply in circumstances corresponding to retail sale at or from that registered pharmacy.

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The ... Ministers may make regulations prescribing conditions which must be complied with if a thing is to be considered for the purposes of this section as done under the supervision of a pharmacist.

Conditions prescribed under subsection (7A) may relate to supervision in the case where the pharmacist is not at the place where the thing is being done, and in that case the thing is not to be so considered if no such conditions are prescribed.

In any case, compliance with any applicable conditions is sufficient for the thing to be so considered.

For the purposes of this section “advertisement" shall have the meaning assigned to it by regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations.

In subsection (1) of this section, “care home service" has the meaning given by paragraph 2 of schedule 12 to the Public Services Reform (Scotland) Act 2010 (asp 8) .

The restrictions imposed by section 8 of this Act do not apply to the assembly of any medicinal products by a person in the course of that person's profession as a registered nurse or as a certified midwife or, in relation to England and Wales, as an exempted midwife.

In this section—

The restrictions imposed by sections 7 and 8 of this Act do not apply to the sale, supply, manufacture or assembly of any herbal remedy in the course of a business where—

Those restrictions also do not apply to the sale, supply, manufacture or assembly of any herbal remedy where the process to which the plant or plants are subjected in producing the remedy consists only of drying, crushing or comminuting, and the remedy is, or is to be, sold or supplied—

The restriction imposed by section 7(3) of this Act does not apply to the importation of a medicinal product by any person for administration to himself or to any person or persons who are members of his household, and does not apply to the importation of a medicinal product where it is specially imported by or to the order of a doctor or dentist for administration to a particular patient of his.

Without prejudice to the preceding subsection, the restriction imposed by section 7(3) of this Act shall not apply to the importation of a medicinal product in such circumstances as may be specified in an order made by the Ministers for the purposes of this section.

Any exemption conferred by an order under this section may be conferred either in relation to medicinal products generally or in relation to a class of medicinal products specified in the order, and (in either case) may be so conferred subject to such conditions or limitations as may be so specified.

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The ... Ministers may by order provide that any of the provisions of section 10 of this Act specified in the order shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be so specified.

No order shall be made under subsection (3) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

The restrictions imposed by sections 7 and 8 of this Act do not apply to anything done before such day as the Ministers may by order appoint for the purposes of this subsection (in this Act referred to as " the first appointed day"); and, except as otherwise provided by any order made under section 17 of this Act, the following provisions of this section shall have effect in relation to things done on or after that day.

Section 7(2) of this Act shall not have effect in relation to a person in respect of his selling or supplying, or procuring the sale, supply, manufacture or assembly of, medicinal products of any description if, in the course of a business carried on by him, any medicinal products of that description were sold or supplied, or procured to be sold, supplied, manufactured or assembled, at any time before the first appointed day and medicinal products of that description were effectively on the market in the United Kingdom immediately before the first appointed day, and either—

Section 7(3) of this Act shall not have effect in relation to a person in respect of his importing medicinal products of any description in the course of a business carried on by him if, in the course of that business, medicinal products of that description were imported within the period of twenty-four months ending with the first appointed day.

Section 8(2) of this Act shall not have effect in relation to a person in respect of his manufacturing or assembling medicinal products of any description in the course of a business carried on by him if in the course of that business— Provided that this subsection shall not have effect in relation to any particular operations carried out in the course of a business on or after the first appointed day unless the manufacture or assembly of the products as mentioned in paragraph (a) or paragraph (b) of this subsection, as the case may be, included those operations.

Section 8(3) of this Act shall not have effect in relation to a person in respect of his selling or offering for sale any medicinal products by way of wholesale dealing in the course of a business carried on by him if, in the course of that business, medicinal products were being sold or offered for sale by way of wholesale dealing within the period of twelve months ending with the first appointed day.

Any application for the grant of a licence under this Part of this Act shall be made to the licensing authority and shall be made in such form and manner, and shall contain, or be accompanied by, such information, documents, samples and other material, as may be prescribed.

Any such application shall indicate the descriptions of medicinal products in respect of which the licence is required, either by specifying the descriptions of medicinal products in question or by way of an appropriate general classification.

Subject to the following provisions of this Part of this Act, in dealing with an application for a product licence the licensing authority shall in particular take into consideration—

In taking into consideration the efficacy for a particular purpose of medicinal products of a description to which such an application relates, the licensing authority shall leave out of account any question whether medicinal products of another description would or might be equally or more efficacious for that purpose: Provided that nothing in this subsection shall be construed as requiring the licensing authority, in considering the safety of medicinal products of a particular description, in relation to a purpose for which they are proposed to be administered, to leave out of account any question whether medicinal products of another description, being equally or more efficacious for that purpose, would or might be safer in relation to that purpose.

Where any such application indicates that the purposes for which the licence is required relate (wholly or partly) to medicinal products which have been or are to be imported, then in dealing with the application, in so far as it relates to such products, the licensing authority shall also take into consideration in particular the methods, standards and conditions of manufacture of those products and may, if they think fit, require the production by the applicant of any one or more of the following, that is to say—

Where any such application indicates that the purposes for which the licence is required relate exclusively to the exportation of medicinal products, the licensing authority shall leave out of account considerations of safety and efficacy (as mentioned in paragraphs (a) and (b) of subsection (1) of this section) if satisfied that in the circumstances it is reasonable to do so.

In dealing with an application for a manufacturer's licence the licensing authority shall in particular take into consideration—

In dealing with an application for a wholesale dealer's licence the licensing authority shall in particular take into consideration—

The preceding provisions of this section shall have effect subject to the provisions of this Part of this Act relating to licences of right.

Subject to the last preceding section, and to the following provisions of this Act, on any application to the licensing authority for a licence under this Part of this Act the licensing authority—

The licensing authority shall not refuse to grant such a licence on any grounds relating to the price of any product, and shall not insert in any such licence any provisions as to the price at which any product may be sold, supplied, imported or exported.

The licensing authority shall not refuse to grant such a licence on any grounds relating to the safety, quality or efficacy of medicinal products of any description, except after consultation with the appropriate committee or, if for the time being there is no such committee, with the Commission.

Where the licensing authority grant a licence under this Part of this Act, they shall send a copy of the licence to every committee established under section 4 of this Act whose functions consist of or ,include the giving, in relation to medicinal products of any description to which the licence relates, of advice with respect to safety, quality or efficacy, or, if for the time being there is no such committee, the licensing authority shall send a copy of the licence to the Commission.

Where on an application for a licence under this Part of this Act— the licensing authority shall serve on the applicant a notice stating the reasons for their decision.

Where the appropriate committee or the Commission are consulted under subsection (3) of section 20 of this Act with respect to an application for the grant of a licence, and on any such grounds as are specified in that subsection they have reason to think that they may be unable to advise the licensing authority to grant the licence, or may be unable to advise the licensing authority to grant it unless it contains provisions otherwise than in accordance with the application, the committee or Commission shall notify the applicant accordingly, and, before giving their advice to the licensing authority, shall afford to him an opportunity of appearing before and being heard by them, or of making representations in writing to them with respect to those grounds.

Where the applicant has availed himself of the opportunity of being heard under the preceding subsection, or after considering any representations made by him under that subsection, the appropriate committee or the Commission, as the case may be, shall report to the licensing authority their findings and advice and the reasons for their advice and the licensing authority shall take that report into account in determining the application.

Whether the applicant has been heard or has made representations under subsection (1) of this section or not, if the appropriate committee or the Commission advise the licensing authority that the licence ought on any such grounds as are referred to in that subsection to be refused, or ought, if granted, to contain provisions specified in their advice, the licensing authority shall serve notice on the applicant stating the advice so given to the authority and the reasons stated by the appropriate committee or the Commission for giving that advice.

If, within the time allowed after the service of a notice under subsection (3) of this section, in a case where the applicant has not been heard by, or made representations to, the Commission under subsection (1) of this section, he gives notice to the licensing authority of his desire to be heard with respect to the advice given to the authority, or makes representations in writing to the licensing authority with respect to that advice, then, before determining the application.— and, where the applicant has availed himself of the opportunity of being heard, or after considering the representations, as the case may be, the Commission shall report to the licensing authority their findings and advice and the reasons for their advice, and the licensing authority shall take that report into account in determining the application.

If the licensing authority— the licensing authority shall notify the applicant accordingly, and, before determining the application, shall afford to the applicant an opportunity of appearing before, and being heard by, a person appointed for the purpose by the licensing authority, or of making representations in writing to the licensing authority with respect to that proposal.

Any notification given to the applicant under subsection (5) of this section— and in a case falling within paragraph (d) of that subsection (whether it also falls within any of the other paragraphs of that subsection or not) the notification shall include a statement of the proposals of the licensing authority and of the reasons for them.

Where under subsection (5) of this section the applicant avails himself of the opportunity of appearing before, and being heard by, a person appointed for the purpose by the licensing authority—

In this Part of this Act " the time allowed " means the period of twenty-eight days or such extended period as the licensing authority may in any particular case allow.

The provisions of this section shall have effect where an application is made for the grant of a licence under this Part of this Act and the provisions of section 21 of this Act do not apply.

If the licensing authority propose to refuse to grant the licence, or propose to grant a licence otherwise than in accordance with the application, they shall serve notice on the applicant stating their proposals and the reasons for them.

If, within the time allowed after the service of a notice under subsection (2) of this section, the applicant gives notice to the licensing authority of his desire to be heard under this subsection, or makes representations in writing to the licensing authority with respect to their proposals, then, before determining the application, the licensing authority shall afford to him an opportunity of appearing before, and being heard by, a person appointed for the purpose by the licensing authority, or shall take those representations into account, as the case may be.

Subsection (7) of section 21 of this Act shall have effect in relation to a person appointed under subsection (3) of this section as it has effect in relation to a person appointed under subsection (5) of that section.

Subject to the provisions of this Part of this Act relating to clinical trials and medicinal tests on animals and to the following provisions of this section, a manufacturer's licence shall not have effect so as to authorise the manufacture or assembly of medicinal products of any description for sale or supply to any other person, or for exportation, unless either— and (in either case) the products are manufactured or assembled in accordance with that product licence.

Subject to the next following subsection, the preceding subsection shall not have effect in relation to the manufacture or assembly of any medicinal product to the order of a practitioner, where the practitioner— and shall not have effect in relation to the manufacture or assembly of any medicinal product to the order of a pharmacist in accordance with a prescription given by a practitioner.

The exemption conferred by the last preceding subsection— does not apply to a vaccine specially prepared for administration to poultry.

If by virtue of an order made under section 15 of this Act an exemption is conferred in respect of the restrictions imposed by section 7 of this Act, but no corresponding exemption is conferred in respect of the restrictions imposed by section 8(2) of this Act, the order may provide that subsection (1) of this section shall have effect subject to such exceptions or modifications as the Ministers consider appropriate in the circumstances.

Where subsection (1) of this section has effect in relation to medicinal products of any description, and the conditions specified in that subsection are not fulfilled, the manufacture or assembly of medicinal products of that description for sale or supply to another person, or for exportation, notwithstanding that it complies with the provisions contained in the manufacturer's licence, shall for the purposes of this Act be deemed to be not in accordance with that licence.

Subject to the following provisions of this section, every licence granted under this Part of this Act, unless previously renewed or revoked, shall expire at the end of the period of five years from the date on which it was granted or the date as from which it was last renewed, as the case may be, or at the end of such shorter period from that date as may be specified in the licence as granted or last renewed.

Any such licence, if it has not been revoked, may, on the application of the holder of the licence, be renewed by the licensing authority for a further period of five years from the date on which it would otherwise expire or such shorter period from that date as the licensing authority may determine.

On an application to the licensing authority for the renewal of a licence under this Part of this Act, the licensing authority—

In relation to any such application the provisions of sections 18 and 19, subsections (2) to (5) of section 20 and sections 21 and 22 of this Act shall have effect as if in those provisions any reference to refusing a licence included a reference to refusing to renew a licence and any reference to granting a licence included a reference to renewing it.

Every application for the grant or renewal of a licence under this Part of this Act shall, unless it otherwise expressly provides, be taken to be an application for the grant or renewal of the licence for the full period of five years mentioned in subsection (1) or subsection (2) of this section, as the case may be; and in this Part of this Act any reference (including a reference implied by virtue of the last preceding subsection) to the grant or renewal of a licence otherwise than in accordance with the application shall be construed accordingly.

Where an application for the renewal of a licence under this Act has been duly made—

Where any of the provisions of subsections (2) to (5) of section 16 of this Act has effect in relation to a person, he may, before such date as may be appointed for the purposes of this section by an order made by the Ministers, make an application in accordance with section 18 of this Act, stating that it is an application for a licence of right.

On any such application made as mentioned in the preceding subsection the applicant, on proving that any of the provisions of subsections (2) to (5) of section 16 of this Act has effect in relation to him, shall be entitled to the grant of a licence under this Part of this Act in accordance with the next following section.

In this section and in sections 26 and 27 of this Act any reference to proof is a reference to proof to the reasonable satisfaction of the licensing authority

In this Act " licence of right" means a licence to which a person is entitled by virtue of this section, including such a licence which has been renewed (with or without modifications) but not a licence granted instead of the renewal of such a licence.

Where a person is entitled to the grant of a licence of right by reason that subsection (2) or subsection (3) of section 16 of this Act has effect in relation to him, he shall be entitled to the grant of a product licence ; but, subject to the following provisions of this section.—

Where a person is entitled to the grant of a licence of right by reason that subsection (4) of section 16 of this Act has effect in relation to him, he shall be entitled to the grant of a manufacturer's licence; but, subject to the following provisions of this section, the licence shall be granted so as not to extend—

Where a person is entitled to the grant of a licence of right by reason that subsection (5) of section 16 of this Act has effect in relation to him, he shall be entitled to the grant of a wholesale dealer's licence.

A licence of right granted in accordance with subsection (1) or subsection (2) of this section shall (without prejudice to either of those subsections) be granted subject to such provisions as appear to the licensing authority to be requisite for securing that the specification of medicinal products of any description to which the licence relates, and the purposes for which any such products are authorised by the licence to be sold, supplied, exported, imported, manufactured or assembled, will be in accordance with those stated in the application for the licence.

Where a licence of right— the provisions of the licence so issued, and the provisions of any regulations made under Part I of the Therapeutic Substances Act 1956 or (as the case may be) of any order made under Part II of the said Act of 1950 or of the said Act of 1958, in so far as immediately before that day they were applicable to medicinal products of that description, shall be deemed to be incorporated in the licence of right granted under this Act, in its application to medicinal products of that description, and shall have effect accordingly as provisions of the licence of right until it expires or is renewed.

A breach of any requirement imposed by this section in respect of the grant of a licence shall not invalidate the licence ; and, except as provided by section 107 of this Act, the duty of the licensing authority to comply with any such requirement shall not be enforceable by any legal proceedings.

Sections 19 to 22 of this Act shall not have effect in relation to any application for a licence of right.

If on any such application the licensing authority— the licensing authority shall, before the end of the period of three months from the date on which the application is received by them, serve on the applicant a notice stating their proposals and the reasons for them and, in a case falling within paragraph (b) of this subsection, the matters specified in the application to which it is proposed that the licence should not extend.

If, within the time allowed after the service of a notice under subsection (2) of this section, the applicant gives notice to the licensing authority of his desire to be heard under this subsection or makes representations in writing to the licensing authority with respect to their proposals, then, before determining the application, the licensing authority shall afford to him an opportunity of appearing before, and being heard by, a person appointed for the purpose by the licensing authority, or shall take those representations into account, as the case may be.

Where the applicant avails himself of the opportunity afforded to him in pursuance of subsection (3) of this section or makes representations in writing as mentioned in that subsection, then if— the licensing authority shall serve on the applicant a notice stating the reasons for their decision.

If, in a case where the licensing authority have served a notice under subsection (2) of this section, the application is not finally disposed of before the date which, in relation to any matters specified in the application, is the relevant date, then on and after that date, and until the application has been finally disposed of, the provisions of this Act shall have effect in relation to those matters as if the licensing authority had granted a licence of right in accordance with the application.

Where, on an application for a licence of right, the licensing authority do not serve a notice under subsection (2) of this section before the end of the period mentioned in that subsection, the licensing authority shall be required to grant a licence in accordance with sections 25 and 26 of this Act as if all the matters specified in the application had been proved; and if such a licence has not been granted before the date which, in relation to any of those matters, is the relevant date, the provisions of this Act shall have effect on and after that date in relation to those matters as if the licensing authority had granted a licence of right in accordance with the application.

For the purposes of this section the relevant date, in relation to any matters specified in an application, is the date on which, in accordance with one or more orders made under section 17 of this Act, that subsection of section 16 of this Act which has effect in relation to those matters ceases to have effect in relation to them ; and an application shall for the purposes of this section be taken to be finally disposed of on (but not before) the occurrence of whichever of the following events last occurs, that is to say—

Subsection (7) of section 21 of this Act shall have effect in relation to a person appointed under subsection (3) of this section as it has effect in relation to a person appointed under subsection (5) of that section.

Subject to the following provisions of this Part of this Act, the licensing authority may suspend a licence under this Part of this Act for such period as the authority may determine, or may revoke, or vary the provisions of, any such licence.

The suspension or revocation of a licence under this section may be total or may be limited to medicinal products of one or more descriptions or to medicinal products manufactured, assembled or stored on any particular premises or in a particular part of any premises.

The powers conferred by this section shall not be exercisable by the licensing authority in relation to a product licence except on one or more of the following grounds, that is to say—

Subject to the following provisions of this section, the powers conferred by this section shall not be exercisable in relation to a manufacturer's licence or a wholesale dealer's licence except on one or more of the following grounds, that is to say—

In relation to a manufacturer's licence, the powers conferred by this section shall be exercisable on either of the following grounds, in addition to those specified in subsection (4) of this section, that is to say—

In relation to a wholesale dealer's licence, the powers conferred by this section shall be exercisable on the following grounds, in addition to those specified in subsection (4) of this section, that is to say, that the equipment and facilities for storing or distributing medicinal products which are available to the holder of the licence are inadequate to maintain the quality of medicinal products of one or more descriptions to which the application for the licence related.

The preceding provisions of this section shall have effect subject to the next following section.

The provisions of Schedule 2 to this Act shall have effect where the licensing authority propose to exercise any power conferred by section 28 of this Act.

Without prejudice to any requirement of that Schedule as to the service of notices, where in the exercise of any such power the licensing authority suspend, revoke or vary a licence, they shall serve on the holder of the licence a notice giving particulars of the suspension, revocation or variation and of the reasons for their decision to suspend, revoke or vary the licence.

In this Act " clinical trial " means an investigation or series of investigations consisting of the administration of one or more medicinal products of a particular description— where (in any such case) there is evidence that medicinal products of that description have effects which may be beneficial to the patient or patients in question and the administration of the product or products is for the purpose of ascertaining whether, or to what extent, the product has, or the products have, those or any other effects, whether beneficial or harmful.

Subject to the following provisions of this Act, no person shall, in the course of a business carried on by him.— unless one or other of the conditions specified in the next following subsection is fulfilled.

Those conditions, in relation to a person doing any of the things specified in the preceding subsection, are—

Subject to the following provisions of this Act, no person shall import any medicinal product for the purposes of a clinical trial unless either—

Subject to the next following subsection, the restrictions imposed by the preceding provisions of this section do not apply to a doctor or dentist in respect of his selling or supplying, or procuring the sale or supply of, a medicinal product, or procuring the manufacture or assembly of a medicinal product specially prepared to his order, or specially importing a medicinal product, where (in any such case) he is, or acts at the request of, the doctor or dentist by whom, or under whose direction, the product is to be administered.

The exemptions conferred by the last preceding subsection do not apply in a case where the clinical trial in question is to be carried out under arrangements made by, or at the request of, a third party (that is to say, a person who is not the doctor or dentist, or one of the doctors or dentists, by whom, or under whose direction, one or more medicinal products are to be administered in that trial).

The restrictions imposed by subsection (2) of this section do not apply to anything which is done in a registered pharmacy, a hospital or a health centre and is done there by or under the supervision of a pharmacist in accordance with a prescription given by a doctor or dentist; and those restrictions do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a doctor or dentist, or of procuring the assembly of a medicinal product.

The restrictions imposed by subsection (2) of this section also do not apply to anything done in relation to a medicinal product where—

For the purposes of this section a product licence shall be taken to be a licence which authorises a particular clinical trial if—

A clinical trial certificate may certify as mentioned in subsection (3)(b) of this section without specifying the doctor or dentist (or, if there is to be more than one, any of the doctors or dentists) by whom, or under whose direction, any medicinal product is to be administered, or the patient or patients to whom any medicinal product is to be administered.

Subject to the following provisions of this Act, no person shall, in the course of a business carried on by him.— unless one or other of the conditions specified in the next following subsection is fulfilled.

Those conditions, in relation to a person doing any of the things specified in the preceding subsection, are—

Subject to the following provisions of this Act, no person shall import any medicinal product for the purposes of a medicinal test on animals unless either—

Subject to the following provisions of this Act, no person shall, in the course of a business carried on by him, administer any substance or article to an animal by way of a medicinal test on animals, or procure any substance or article to be so administered, unless either—

For the purposes of this section a product licence shall be taken to be a licence which authorises a particular medicinal test on animals if—

In this Act" medicinal test on animals " means an investigation or series of investigations consisting of any of the following, that is to say—

The restrictions imposed by subsections (1) and (4) of section 32 of this Act do not apply to anything done in relation to a substance or article for the purposes or by way of a medicinal test on animals if—

Subject to the next following subsection, the restrictions imposed by subsections (1) and (4) of that section do not apply to a veterinary surgeon or veterinary practitioner in respect of his—

Subsection (2) of this section shall not have effect in relation to a veterinary surgeon or veterinary practitioner where the medicinal test in question is to be carried out under arrangements made by, or at the request of, another person, and (where the arrangements are made by the veterinary surgeon or veterinary practitioner and not at the request of any other person) shall not have effect so as to exempt from the restrictions in question anything done—

Subject to subsection (6) of this section, the restrictions imposed by subsection (1) of that section do not apply to anything which is done in a registered pharmacy and is done there by or under the supervision of a pharmacist and consists of dispensing a medicinal product in accordance with a prescription given by a veterinary surgeon or veterinary practitioner; and those restrictions do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a veterinary surgeon or veterinary practitioner or of procuring the assembly of a medicinal product.

Subject to subsection (6) of this section, the restrictions imposed by subsection (1) of that section also do not apply to anything done in relation to a medicinal product where—

The exemptions conferred by subsections (4) and (5) of this section do not apply to a vaccine specially prepared for administration to poultry, and do not apply to any other vaccine or any plasma or serum prepared or dispensed for administration to an animal or herd unless—

Subject to the following provisions of this Act, no person shall in the course of a business carried on by him sell or supply for human consumption an animal to which in the course of that business a substance or article has been administered by way of a test to which this section applies, or the carcase or any part of the carcase or any produce of such an animal, unless—

This section applies to any medicinal test on animals which is carried out in the course of the business of the person who has manufactured the substance or article administered in the test, or is carried out on his behalf in the course of the business of a laboratory or research establishment carried on by another person, and (in either case) is so carried out on one or more animals kept in the course of the business of the person carrying out the test.

The restrictions imposed by section 7 of this Act do not apply to anything done in accordance with a clinical trial certificate or an animal test certificate.

The restrictions imposed by section 8(2) of this Act—

No class of medicinal products shall be specified in an order for the purposes of paragraph (b) of subsection (2) of this section unless it appears to the Agriculture Ministers to be requisite to do so for securing that the exemption conferred by that paragraph does not apply to medicinal products consisting wholly or partly of substances the purity or potency of which cannot, in their opinion, be adequately tested by chemical means.

Neither the restrictions imposed by section 7 of this Act nor those imposed by section 31(2) of this Act apply to anything done exclusively for the purpose of a clinical trial which is to be carried out wholly outside the United Kingdom; and neither the restrictions imposed by section 7 of this Act nor those imposed by section 32(1) of this Act apply to anything done in relation to a medicinal product for the purposes of a medicinal test on animals which is to be carried out wholly outside the United Kingdom, unless the product falls within a class specified in an order made for the purposes of subsection (2)(b) of this section.

Where the holder of a manufacturer's licence manufactures or assembles any medicinal product for sale or supply for the purposes of a clinical trial or a medicinal test on animals, and— then, if the conditions specified in subsection (1) of section 23 of this Act are not fulfilled in relation to the product, that section shall have effect in relation to it as if those conditions were fulfilled.

Without prejudice to subsection (5) of this section, section 23(1) of this Act shall not have effect in relation to the manufacture or assembly of any medicinal product for sale or supply for the purposes of a medicinal test on animals, where the product falls within a class specified in an order made for the purposes of subsection (2)(b) of this section.

For the purposes of sections 31 and 32 of this Act a person shall not be treated as doing anything, or procuring anything to be done, for the purposes of a clinical trial or of a medicinal test on animals if—

The appropriate Ministers may by order provide—

Any exemption conferred by an order under subsection (8) of this section may be conferred subject to such conditions or limitations as may be specified in the order.

The appropriate Ministers may by order provide that any of the provisions of subsections (5) to (8) of section 31 of this Act, or any of the provisions of section 33 of this Act, or subsection (4) of this section, shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be specified in the order.

No order shall be made under subsection (10) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

Any application for a clinical trial certificate or an animal test certificate shall be made to the licensing authority and shall be made in such form and manner, and shall contain, or be accompanied by, such information, documents, samples and other material, as may be prescribed.

In dealing with any such application, the licensing authority shall have regard in particular to any evidence available to them as to any risks involved in the proposed clinical trial or medicinal test on animals.

Subject to the next following section, the provisions of sections 20 to 22 of this Act shall have effect in relation to applications for clinical trial certificates or animal test certificates, as if in those sections any reference to a licence under this Part of this Act were a reference to such a certificate.

The provisions of sections 31, 32, 34 and 36 of this Act shall have effect subject to the following provisions of this section.

The restrictions imposed by sections 31 and 32 of this Act do not apply to anything done before the first appointed day, and the restrictions imposed by section 34 of this Act do not apply where the substance or article in question was administered before that day.

Where, in the course of a series of investigations carried out during a period ending on the first appointed day.— the restrictions imposed by section 31 or section 32 of this Act do not apply to anything done in relation to medicinal products of that description or (as the case may be) in relation to similar substances or articles for the purpose of continuing that series of investigations, if it is done on or after the first appointed day but before such date as may be appointed for the purposes of this section by an order made by the Ministers.

If, on an application for a clinical trial certificate or an animal test certificate which is made before the date appointed for the purposes of this section, it is proved to the reasonable satisfaction of the licensing authority that— the applicant shall be entitled to the issue of a certificate such as will enable the series to be continued and completed within a reasonable time after the date appointed for the purposes of this section.

Section 36(3) of this Act shall not have effect in relation to any application for a certificate as being a certificate to which the applicant is entitled by virtue of subsection (4) of this section; but the provisions of section 27 of this Act shall have effect in relation to any such application, as if— and for the purposes of the application of those provisions in accordance with this subsection the relevant date, in relation to any matters specified in the application, shall be the date appointed for the purposes of this section.

Subject to the following provisions of this section, every clinical trial certificate or animal test certificate, unless previously renewed or revoked, shall expire at the end of the period of two years from the date on which it was issued or the date as from which it was last renewed, as the case may be, or at the end of such shorter period from that date as may be specified in the certificate as issued or last renewed.

Any such certificate, if it has not been revoked, may, on the application of the holder of the certificate, be renewed by the licensing authority for a further period of two years from the date on which it would otherwise expire or such shorter period from that date as the licensing authority may determine.

Subsections (1) and (2) of section 36 of this Act shall have effect in relation to applications for the renewal of such certificates as they have effect in relation to applications for the issue of such certificates.

On an application for the renewal of such a certificate the licensing authority—

In relation to any such application the provisions of subsections (2) to (5) of section 20, and of sections 21 and 22, of this Act shall have effect as if in those provisions any reference to refusing a licence under this Part of this Act included a reference to refusing to renew a clinical trial certificate or animal test certificate and any reference to granting such a licence included a reference to renewing such a certificate.

Every application for the grant or renewal of a clinical trial certificate or animal test certificate shall, unless it otherwise expressly provides, be taken to be an application for the grant or renewal of the certificate for the full period of two years mentioned in subsection (1) or subsection (2) of this section, as the case may be ; and in any provisions of section 21 or section 22 of this Act as applied by the last preceding subsection any reference to the grant or renewal of a certificate otherwise than in accordance with the application shall be construed accordingly.

Where an application for the renewal of such a certificate has been duly made—

Subject to the following provisions of this section, the licensing authority may suspend, for such period as the authority may determine, a clinical trial certificate or animal test certificate, or may revoke, or vary the provisions of, any such certificate.

The powers conferred by this section shall not be exercisable by the licensing authority except on one or more of the following grounds, that is to say—

The provisions of section 29 of, and Schedule 2 to, this Act shall have effect in relation to a clinical trial certificate or animal test certificate as they have effect in relation to a product licence, as if in paragraph 1 of that Schedule the reference to paragraph (g) or paragraph (h) of section 28(3) of this Act were a reference to paragraph (e) or paragraph (f) of subsection (2) of this section.

Without prejudice to any power exercisable by virtue of the preceding provisions of this section, the licensing authority may, on the application of the holder of a clinical trial certificate or animal test certificate, vary the provisions of the certificate in accordance with any proposals contained in the application, if they are satisfied that the variation will not adversely affect the safety, quality or efficacy of medicinal products of any description to which the certificate relates.

No person shall, in the course of a business carried on by him, sell, offer for sale, supply or export, or procure the sale, supply or exportation or the manufacture for sale, supply or exportation of, any animal feeding stuff in which a medicinal product has been incorporated, unless—

No person shall import any animal feeding stuff in which a medicinal product has been incorporated unless the conditions specified in paragraph (a) or paragraph (b) of the preceding subsection are fulfilled.

No person shall, in the course of a business carried on by him, incorporate a medicinal product of any description in any animal feeding stuff unless—

The provisions of section 40 of this Act shall have effect subject to the following provisions of this section.

The restrictions imposed by that section do not apply to anything done before the first appointed day.

The restrictions imposed by subsection (1) of that section do not apply to anything done on or after the first appointed day in relation to any animal feeding stuff in which a medicinal product of any description has been incorporated, and the restrictions imposed by subsection (3) of that section do not apply to anything done on or after that day which consists of incorporating a medicinal product of any description in any animal feeding stuff, if (in either case) it is done—

The restriction imposed by section 40(2) of this Act does not apply to the importation on or after the first appointed day of any animal feeding stuff in which a medicinal product of any description has been incorporated if it is imported—

Where in the course of a business carried on by him a person incorporates a substance or article, other than a medicinal product, in any animal feeding stuff with a view to— and the substance or article is so incorporated by him for a medicinal purpose, sections 40(3) and 41 of this Act shall have effect in relation to the incorporation of that substance or article as if it were a medicinal product.

Where in the course of a business carried on by him a person proposes— he may, if he so desires, apply for a product licence in respect of that substance or article, and the licensing authority (subject to the provisions of sections 19 to 22 of this Act) may grant to him a product licence in respect of it, as if it were a medicinal product and he were proposing to sell or supply it in circumstances to which section 7(2) of this Act applies; and a product licence so granted may be renewed, suspended, revoked or varied accordingly.

Where a person proposes to sell, supply or manufacture a substance or article, other than a medicinal product, in the circumstances specified in paragraph (a) or paragraph (b) of subsection (2) of this section, any person who proposes, by purchase or otherwise, to obtain from him a supply of the substance or article with a view to incorporating it for a medicinal purpose in any animal feeding stuff may, if he so desires, apply for a product licence in respect of that substance or article, and the licensing authority (subject to the provisions of sections 19 to 22 of this Act) may grant to him a product licence in respect of it, as if it were a medicinal product and he were proposing to procure the sale or supply, or the manufacture for sale or supply, of that product in circumstances to which section 7(2) of this Act applies; and a product licence so granted may be renewed, suspended revoked or varied accordingly.

On the grant, renewal or variation (whether by virtue of subsection (2) or subsection (3) of this section or otherwise) of a product licence, in so far as it relates to any substance or article which is to be incorporated in animal feeding stuffs, the licence may (without prejudice to the generality of section 20(1) of this Act) include provisions as to the manner in which the substance or article in question may be so incorporated, whether by the holder of the licence or by any other person to whom those provisions of the licence have been communicated.

Without prejudice to the operation of section 130(7) of this Act, a substance manufactured, sold, supplied or exported as an animal feeding stuff shall not be taken to be a medicinal product for the purposes of this Act by reason only that any of the preceding provisions of this section has effect in relation to a substance or article incorporated in it.

The appropriate Ministers may by order provide that any of the provisions of section 40 of this Act or of subsections (1) to (5) of this section shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be specified in the order.

No order shall be made under subsection (6) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

Where in the course of a business carried on by him a person sells, supplies or exports a substance or article for use wholly or mainly in either or both of the ways specified in section 130(1) of this Act, and the substance or article, not having been— does not constitute a medicinal product before that person so sells, supplies or exports it, then (subject to subsection (2) of this section) subsection (2) of section 7 of this Act, if apart from this subsection it would not so have effect, shall have effect in relation to the sale, supply or exportation of the substance or article as if he were selling, supplying or exporting it in circumstances to which that subsection applies.

Subsection (1) of this section shall not have effect in relation to a transaction whereby a person, in the course of a business carried on by him, sells a substance or article by retail or supplies a substance or article in circumstances corresponding to retail sale unless in the course of that business the substance or article has been assembled for the purpose of being sold or supplied by him.

In any reference in this Part of this Act to the provisions of, or the restrictions imposed by, section 7 of this Act, the reference to that section shall be construed as including a reference to subsection (2) of that section as extended by the preceding subsections.

Where in the course of a business carried on by him a person proposes to sell, supply or export a substance or article for use as mentioned in subsection (1) of this section, where the substance or article will not constitute a medicinal product before he so sells, supplies or exports it and he will not be selling, supplying or exporting it in circumstances to which section 7(2) of this Act applies, he may, if he so desires, apply for a product licence in respect of that substance or article, and the licensing authority (subject to the provisions of sections 19 to 22 of this Act) may grant to him a product licence in respect of it, as if he were proposing to sell, supply or export it in circumstances to which section 7(2) of this Act applies ; and a product licence so granted may be renewed, suspended, revoked or varied accordingly.

In subsection (2) of this section the reference to assembling a substance or article in the course of a business carried on by a person is a reference to doing in the course of that business anything which (in accordance with section 132(1) of this Act) would constitute assembling if it had been a medicinal product when sold or supplied to him.

Where an application has been made to the licensing authority for a licence under this Part of this Act (including a licence of right) or for a clinical trial certificate or animal test certificate (including a certificate to which a person is entitled by virtue of section 37(4) of this Act) the licensing authority, before determining the application, may request the applicant to furnish to the licensing authority such information relating to the application as the licensing authority may consider requisite; and, where any such request has been made, the licensing authority shall not be required to determine the application until either—

The licensing authority may serve on the holder of a licence under this Part of this Act, or of a clinical trial certificate or animal test certificate, a notice requiring him, within such time as may be specified in the notice, to furnish to the licensing authority information of any description specified in the notice in accordance with the following provisions of this section.

Except as provided by subsection (4) of this section, a notice under subsection (2) of this section shall not be served unless it appears to the licensing authority, or it is represented to them by the Commission or by the appropriate committee, that circumstances exist by reason of which it is necessary to consider whether the licence or certificate should be varied, suspended or revoked; and the information required by such a notice shall be such as appears to the licensing authority, or is represented to them by the Commission or by the committee, to be requisite for considering that question.

Subsection (3) of this section shall not have effect in the case of a licence of right, or of a certificate issued in pursuance of section 37 (4) of this Act, whether the licence or certificate has been renewed or not; and, in the case of such a licence or certificate, a notice under this section may be served at any time and may require any information which, in the opinion of the licensing authority, would be relevant if—

Before the end of the period of two years from the date on which a product licence, other than a licence of right, is granted, the holder of the licence shall, in respect of each description of medicinal products to which the licence relates which is effectively on the market in the United Kingdom within that period, notify to the licensing authority a date on which medicinal products of that description were effectively on that market.

Subject to the next following section, any person who contravenes any of the provisions of section 7, section 8, section 31, section 32, section 34 or section 40 of this Act, or who is in possession of any medicinal product or animal feeding stuff for the purpose of selling, supplying or exporting it in contravention of any of those sections, shall be guilty of an offence.

Where any medicinal product or animal feeding stuff is imported in contravention of section 7, section 31, section 32 or section 40 of this Act, any person who, otherwise than for the purpose of performing or exercising a duty or power imposed or conferred by or under this Act or any other enactment, is in possession of the product or feeding stuff knowing or having reasonable cause to suspect that it was so imported shall be guilty of an offence.

Any person who, being the holder of a product licence or of a clinical trial certificate or animal test certificate, procures another person to carry out a process in the manufacture or assembly of medicinal products of a description to which the licence or certificate relates, and— shall be guilty of an offence.

Any person who, being the holder of a product licence or of an animal test certificate, sells or supplies a substance or article to which the licence or certificate relates to another person for the purpose of its being incorporated in any animal feeding stuff, and does not communicate to that person any provisions of the licence or certificate which relate to the incorporation of that substance or article in animal feeding stuffs, or any instructions required by the licence to be communicated by him to persons to whom the substance or article is sold or supplied for that purpose, shall be guilty of an offence.

Where any such provisions of a product licence or animal test certificate as are mentioned in subsection (4) of this section are varied by the licensing authority, and on varying those provisions the licensing authority serve on the holder of the licence or certificate a notice requiring him, within such time (not being less than fourteen days from the date of service of the notice) as may be specified in the notice, to take such steps as may be so specified for making the variation known, either generally or to persons or classes of persons specified in the notice, then if the holder of the licence or certificate does not comply with the requirements of that notice he shall be guilty of an offence.

Any person who, in giving any information which he is required to give under section 44 of this Act, makes a statement which he knows to be false in a material particular shall be guilty of an offence.

Any person who without reasonable excuse fails to comply with a requirement imposed on him by a notice under section 44(2) of this Act shall be guilty of an offence.

Any person guilty of an offence under any of subsections (1) to (6) of this section shall be liable—

Any person guilty of an offence under subsection (7) of this section shall be liable on summary conviction to a fine not exceeding £50.

Where the holder of a product licence or of a clinical trial certificate or animal test certificate is charged with an offence under the last preceding section in respect of any substance or article which has been manufactured (or, in the case of a medicinal product, manufactured or assembled) to his order by another person and has been so manufactured or assembled as not to comply with the provisions of that licence or certificate which are applicable to it, it shall be a defence for him to prove—

Where the holder of a manufacturer's licence is charged with an offence under the last preceding section in respect of any medicinal products which have been manufactured or assembled by him, in circumstances where he is not the holder of a product licence or of a clinical trial certificate or animal test certificate which is applicable to those products, but the products were manufactured or assembled to the order of another person, it shall be a defence for him to prove that he believed, and had reasonable grounds for believing.—

Where a person is charged with an offence under the last preceding section in respect of a contravention of any provision of section 40 of this Act, in a case where he is not the holder of such a product licence or animal test certificate as is mentioned in subsection (1)(a) or subsection (3)(a) of the said section 40, it shall be a defence for him to prove that he believed, and had reasonable grounds for believing.—

In the last preceding subsection any reference to section 40 of this Act shall be construed as including a reference to that section as extended by section 42 of this Act.

The Ministers may by regulations prescribe standard provisions for the purposes of this Part of this Act, either generally or in relation to any class of medicinal products specified in the regulations.

Any standard provisions so prescribed may be incorporated by the licensing authority in any licence under this Part of this Act or any clinical trial certificate or animal test certificate granted or issued on or after the date on which the regulations come into operation, and may be so incorporated with or without modifications and either generally or in relation to medicinal products of any particular class.

The following provisions of this section shall have effect where— and in the following provisions of this section, in a case falling within paragraph (a) but not within paragraph (b) of this subsection, " the operative standard provisions " means the standard provisions prescribed by the regulations and " the relevant regulations " means those regulations, and, in any other case, " the operative standard provisions " means the standard provisions as amended by the subsequent regulations or the new standard provisions prescribed by those regulations, as the case may be, and " the relevant regulations " means the subsequent regulations.

Subject to the following provisions of this section, as from the end of the period of three months from the date on which the relevant regulations come into operation, the operative standard provisions shall be deemed to be incorporated in any licence under this Part of this Act, or any clinical trial certificate or animal test certificate, which is in force at the end of that period or, in the case of a suspended licence or certificate, would then be in force if it were not suspended, in so far as, in accordance with the relevant regulations, the operative standard provisions are applicable to medicinal products of any description to which that licence or certificate relates.

Notwithstanding anything in subsection (4) of this section, the operative standard provisions shall not by virtue of that subsection be deemed to be incorporated in any licence of right, or in any certificate issued in pursuance of section 37(4) of this Act, including any such licence or certificate which has been renewed, except in circumstances where, immediately before the first appointed day, the manufacture or importation of substances or articles to which the licence or certificate relates was authorised by a licence issued under Part I of the Therapeutic Substances Act 1956 or under Part II of the Diseases of Animals Act 1950, or of the Diseases of Animals Act (Northern Ireland) 1958, and, where those circumstances exist, shall be deemed to be so incorporated only in relation to substances or articles to which the licence so issued was applicable.

At any time after the relevant regulations are made and before the end of the period of three months from the date on which they come into operation, the holder of any licence or certificate may apply to the licensing authority to direct— and if, on any such application, the licensing authority direct that the operative standard provisions shall not be deemed to be so incorporated, or shall be deemed to be so incorporated subject to exceptions and modifications specified in the direction, with or without provision postponing the date as from which they are to be deemed to be so incorporated, that direction shall have effect notwithstanding anything in subsection (4) of this section.

Where an application is made to the licensing authority tinder subsection (6) of this section, then, if the licensing authority propose to refuse to give a direction in accordance with the application, the licensing authority, before determining the application, shall afford to the applicant an opportunity of appearing before, and being heard by, a person appointed for the purpose by the licensing authority, or of making representations in writing to the licensing authority with respect to that proposal; and, if the licensing authority then determine to refuse to give a direction in accordance with the application, they shall serve on the applicant a notice stating the reasons for their decision.

Without prejudice to any direction given under subsection (6) of this section, where such an application is made— and so much of subsection (7) of section 27 of this Act as relates to the time when an application is to be taken to be finally disposed of shall have effect for the purposes of this subsection as it has effect for the purposes of that section.

The powers conferred on the licensing authority by the preceding provisions of this Part of this Act to vary the provisions of a licence or certificate shall be exercisable with respect to any provisions which, in accordance with this section, are incorporated or deemed to be incorporated in a licence or certificate.

Notwithstanding anything in sections 7 to 47 of this Act but subject to the next following section, in relation to anything done before such day (subsequent to the first appointed day) as the Ministers may by order appoint for the purposes of this subsection (in this section referred to as " the special appointed day ") those sections shall have effect as if in them—

The Ministers shall not make an order under the preceding subsection unless it appears to them to be necessary or expedient to do so for the purpose of giving effect to an agreement to which the United Kingdom or Her Majesty's Government in the United Kingdom is a party or will be a party on the day appointed by the order.

The following provisions of this section shall have effect where an order is made under subsection (1) of this section; and for the purposes of those provisions the relevant transitional conditions shall be taken to be fulfilled by a person in relation to medicinal products of any description if, in the course of a business carried on by him.—

Unless the order expressly excludes the operation of this subsection.—

Where a product licence which is in force on the special appointed day authorises the holder of the licence to sell medicinal products of any description, or to procure the sale, or procure the manufacture or assembly for sale, of medicinal products of any description, that licence shall have effect on and after that day as if— Provided that, if the operation of subsection (4) of this section is not excluded by the order, a product licence shall not have effect as mentioned in this subsection in relation to medicinal products of any description so long as paragraph (a) of that subsection has effect in relation to the holder of the licence in respect of his exporting, or procuring the exportation of, medicinal products of that description.

Where on an application for a product licence made before such date as may be appointed by the order for the purposes of this subsection, which states that it is an application made by virtue of this subsection, it is proved to the reasonable satisfaction of the licensing authority that the applicant fulfilled or will fulfil the relevant transitional conditions in relation to one or more descriptions of medicinal products, then (subject to the next following subsection) he shall be entitled to the grant of a product licence granted so as—

If a person would, on making an application under subsection (6) of this section, be entitled to the grant of a product licence under that subsection in respect of medicinal products of a particular description, and he would at the same time, on making an application as mentioned in section 25(1) of this Act, be entitled to the grant of a licence of right in respect of medicinal products of the same description, he may apply to the licensing authority for a single product licence for both purposes, and he shall be entitled to the grant of a product licence having the same effect as the two licences, if granted separately, would together have had.

Subsection (6) of section 26 of this Act shall have effect for the purposes of subsections (6) and (7) of this section as it has effect for the purposes of that section.

An order made under subsection (1) of this section may contain such provisions relating to proceedings on an application made under subsection (6) or subsection (7) of this section (whether by way of applying with modifications any of the provisions of section 27 of this Act or otherwise) as the Ministers may consider appropriate.

No order shall be made under this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

Nothing in subsection (1) of section 48 of this Act shall affect the operation of any of the provisions of sections 7 to 47 of this Act in relation to any medicinal product falling within a class specified in an order made under this section by the Health Ministers or the Agriculture Ministers.

No class of medicinal products shall be specified in an order made by the Health Ministers or the Agriculture Ministers under this section unless it appears to the Ministers making the order to be requisite to do so for securing that any exemption conferred by section 48(1) of this Act does not apply to medicinal products consisting wholly or partly of substances the purity or potency of which cannot, in their opinion, be adequately tested by chemical means.

Subsections (3) to (7) of section 48 of this Act shall not have effect in relation to medicinal products of any description falling within a class specified in an order under this section which is in force immediately before the day appointed for the purposes of subsection (1) of that section.

Subject to the next following subsection, section 7(2) of this Act shall not have effect in relation to a person in respect of his exporting, or procuring the exportation of, medicinal products of any description falling within a class specified in an order under this section which is in force immediately before the first appointed day if, in the course of a business carried on by that person.—

Sections 17 and 25 of this Act shall have effect in relation to subsection (4) of this section as they have effect in relation to subsections (2) to (5) of section 16 of this Act.

Where a person is entitled to the grant of a licence of right by reason that subsection (4) of this section has effect in relation to him, he shall be entitled to the grant of a product licence ; but, subject to the next following subsection, the licence shall be granted so as not to extend to medicinal products of any description other than those in respect of which the conditions specified in that subsection are proved to the reasonable satisfaction of the licensing authority to have been fulfilled, and shall be limited to exporting, or procuring the exportation of, medicinal products.

Subsection (5) of section 26 of this Act (with the omission of paragraph (b) of that subsection) and subsection (6) of that section shall have effect in relation to the grant of a licence of right in accordance with subsection (6) of this section as those subsections have effect in relation to the grant of such a licence in accordance with subsection (1) of that section.

In relation to any application for a licence of right which is made by virtue of section 25 of this Act as applied by subsection (5) of this section, the provisions of section 27 of this Act shall have effect subject to such modifications as may be specified by order made by the Ministers for the purposes of this subsection.

The appropriate Ministers may by order specify descriptions or classes of medicinal products, as being products which in their opinion can with reasonable safety be sold or supplied otherwise than by, or under the supervision of, a pharmacist.

In this Act any reference to a medicinal product on a general sale list is a reference to a medicinal product of a description, or falling within a class, specified in an order under this section which is for the time being in force.

An order under this section may designate any description or class of medicinal products specified in the order as being medicinal products which, in the opinion of the appropriate Ministers, can with reasonable safety be sold by means of automatic machines ; and any reference in this Act to a medicinal product in the automatic machines section of a general sale list is a reference to a medicinal product of a description, or falling within a class, so designated by any such order which is for the time being in force.

Subject to any exemption conferred by or under this Part of this Act, on and after the appointed day no person shall, in the course of a business carried on by him, sell by retail, or offer or expose for sale by retail, or supply in circumstances corresponding to retail sale, any medicinal product on a general sale list elsewhere than at a registered pharmacy, unless the conditions specified in the following provisions of this section are fulfilled.

The place at which the medicinal product is sold, offered, exposed or supplied as mentioned in the preceding subsection must be premises of which the person carrying on the business in question is the occupier and which he is able to close so as to exclude the public, unless either—

The medicinal product must have been made up for sale in a container elsewhere than at the place at which it is sold, offered, exposed for sale or supplied as mentioned in subsection (1) of this section and the container must not have been opened since the product was made up for sale in it.

The business, so far as concerns the sale or supply of medicinal products, must be carried on in accordance with such conditions (if any) as may be prescribed for the purposes of this section.

On and after the appointed day no person shall sell, or offer or expose for sale, any medicinal product by means of an automatic machine unless it is a medicinal product in the automatic machines section of a general sale list.

The appropriate Ministers may by order provide that no person shall by means of an automatic machine sell, or offer or expose for sale, any medicinal product to which the order applies unless the container in which it is sold, or offered or exposed for sale, complies with such restrictions as to the quantity of the medicinal product, or the number of medicinal products, which it contains as may be specified in the order.

An order under subsection (2) of this section may be made either in respect of medicinal products generally or in respect of medicinal products of a particular description or falling within a particular class specified in the order.

The restrictions imposed by sections 52 and 53 of this Act do not apply to the sale, offer for sale, or supply of a medicinal product—

Those restrictions also do not apply—

The restrictions imposed by those sections do not apply to the sale, offer for sale, or supply of a medicinal product by a veterinary surgeon or veterinary practitioner for administration by him or under his direction to an animal or herd which is under his care.

Expressions to which a meaning is assigned by subsection (2) of section 11 of this Act have the same meanings in this section as in that section.

Subject to the following provisions of this section, the restrictions imposed by sections 52 and 53 of this Act do not apply to anything done at premises of which the person carrying on the business in question is the occupier and which he is able to close so as to exclude the public, and which consists of the sale, or offer or exposure for sale, or the supply in circumstances corresponding to retail sale, of a herbal remedy where the processes to which the plant or plants are subjected consist of drying, crushing or comminuting, with or without any subsequent process of tabletting, pill-making, compressing or diluting with water, but not any other process.

Without prejudice to the preceding subsection, but subject to subsection (3) of this section, those restrictions do not apply to the sale or supply of a herbal remedy where the person selling or supplying the remedy sells or supplies it for administration to a particular person after being requested by or on behalf of that person and in that person's presence to use his own judgment as to the treatment required.

The appropriate Ministers may by order provide that subsections (1) and (2) of this section shall not have effect in relation to herbal remedies of a description, or falling within a class, specified in the order.

The appropriate Ministers may by order provide that section 52 or section 53 of this Act, or both of those sections, shall have effect subject to such exemptions (other than those for the time being having effect by virtue of sections 55 and 56 of this Act) as may be specified in the order.

Any exemption conferred by an order under the preceding subsection may be conferred subject to such conditions or limitations as may be specified in the order.

The appropriate Ministers may by order provide that subsection (1)(b) or subsection (2) of section 55 of this Act shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be specified in the order.

No order shall be made under subsection (3) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

The Ministers may by order specify descriptions or classes of medicinal products as prescription only medicines

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Without prejudice to regulation 223(1) of the 2012 Regulations , any order made by the Ministers for the purposes of this section may provide—

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Any exemption conferred or modification made by an order in accordance with subsection (4)(a) of this section may be conferred or made subject to such conditions or limitations as may be specified in the order.

Before making an order under this section the Ministers shall consult the appropriate committee ....

An order under this section may provide, in relation to an appropriate practitioner, other than a doctor or dentist, that such a person may— only where he complies with such conditions as may be specified in the order in respect of the cases or circumstances in which he may do so.

An order under this section may provide, in relation to a condition specified by virtue of subsection (4A), for the condition to have effect subject to such exemptions as may be specified in the order.

Where a condition is specified by virtue of subsection (4A), any prescription or direction given by a person in contravention of the condition is not (subject to such exemptions or modifications as may be specified in the order by virtue of subsection (4)(a) of this section) given by an appropriate practitioner for the purposes of regulation 214(1) or (2) of the 2012 Regulations .

In subsection (6) “the appropriate committee” means whichever the Ministers consider appropriate of—

The following provisions of this section shall have effect where an order under section 58 of this Act is made so as to apply to all medicinal products which fall within a class specified in the order and are of a description in respect of which the following conditions are fulfilled, that is to say, that—

Where such an order is made in accordance with the preceding subsection—

In subsection (2)(a) of this section " the relevant date ", in relation to medicinal products of any description to which an order made in accordance with subsection (1) of this section applies, means the date on which the order comes into operation, or the date on which the product licence applicable to medicinal products of that description (as mentioned in subsection (1)(b) of this section) comes into operation, whichever is the later.

The ... Ministers shall, subject to subsection (4) of this section, so exercise their powers under section 58(1) of this Act as to secure that every product— is specified as a prescription only medicine.

This subsection applies to any product which—

In considering whether subsection (2) of this section applies to a product the ... Ministers shall take into account whether the product—

Subsection (1) of this section shall not apply in relation to any product if the ... Ministers so determine having regard to—

In this section ...— “the Narcotic Drugs Convention" means the Single Convention on Narcotic Drugs signed by the United Kingdom on 30th March 1961 as amended by the Protocol Amending the Single Convention on Narcotic Drugs signed by the United Kingdom on 25th March 1972 ; and “the Psychotropic Substances Convention" means the Convention on Psychotropic Substances signed by the United Kingdom on 21st February 1971 .

Subject to the following provisions of this section, regulations made by the appropriate Ministers may provide that no person shall sell by retail, or supply in circumstances corresponding to retail sale, a medicinal product of a description specified in the regulations, or falling within a class so specified, unless—

Any regulations made under this section may provide that no person shall administer (otherwise than to himself) a medicinal product of a description specified in the regulations, or falling within a class so specified, unless he is such a practitioner as is mentioned in subsection (1)(a) of this section or a person acting in accordance with the directions of such a practitioner.

The powers conferred by the preceding subsections shall not be exercisable in respect of medicinal products of a particular description, or falling within a particular class, except where it appears to the appropriate Ministers that the sale by retail, or supply in circumstances corresponding to retail sale, or the administration, of such products requires specialised knowledge on the part of the practitioner by whom or under whose directions they are sold, supplied or administered.

Any regulations made under this section in respect of a particular description or class of medicinal products may specify the qualifications and experience which an applicant for a certificate in respect of that description or class of medicinal products must have, and may provide for the appointment of a committee to advise the appropriate Ministers, in such cases as may be prescribed by or determined in accordance with the regulations, with respect to the grant, renewal, suspension and revocation of such certificates.

Any such regulations shall include provision as to the grant, duration, renewal, suspension and revocation of certificates for the purposes of this section, including provision for affording— an opportunity of appearing before, and being heard by, a person appointed for the purpose by the appropriate Ministers or of making representations in writing to those Ministers with respect to that proposal.

Regulations made under this section may provide that, for the purposes of paragraph (b) of subsection (1) of this section, a medicinal product shall not be taken to be sold or supplied in accordance with a prescription as mentioned in that paragraph unless such conditions as are prescribed by the regulations are fulfilled.

Before making any regulations under this section the appropriate Ministers shall consult the appropriate committee, or, if for the time being there is no such committee, shall consult the Commission.

Subject to the following provisions of this section, the ... Ministers, where it appears to them to be necessary to do so in the interests of safety, may by order—

A prohibition imposed by order under this section may be a total prohibition or may be imposed subject to such exceptions as may be specified in the order.

Before making an order under this section the Ministers , unless in their opinion it is essential to make the order with immediate effect to avoid serious danger to health ..., shall consult the appropriate committee ....

Where an order is made under this section without prior consultation with the appropriate committee ... in accordance with subsection (3) of this section, the prohibition imposed by the order shall not have effect after the end of such period, not exceeding three months from the date on which it comes into operation, as may be specified in the order, but without prejudice to the making of any further order in accordance with the provisions of this section (including this subsection).

If any organisation consulted in pursuance of section 129(6) of this Act with respect to a proposal to make an order under this section have given notice to the Ministers of their desire to be heard under this subsection, or have made representations in writing to the Ministers with respect to that proposal, then before making the order— and, where the organisation have availed themselves of the opportunity of being heard, or after considering the representations, as the case may be, the Commission shall report their findings and conclusions to the Ministers and the Ministers shall take that report into account in determining whether to make the order.

Subsection (5) of this section shall not have effect where in the opinion of the ... Ministers it is essential to make the order with immediate effect as mentioned in subsection (3) of this section.

If an order is made under this section and either— the order shall include a statement of the fact that it has been so made.

In this section “the appropriate committee” means whichever the Ministers consider appropriate of—

No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser.

For the purposes of this section the sale of a medicinal product shall not be taken to be otherwise than to the prejudice of the purchaser by reason only that the purchaser buys the product for the purpose of analysis or examination.

Subsection (1) of this section shall not be taken to be contravened by reason only that a medicinal product contains some extraneous matter, if it is proved that the presence of that matter was an inevitable consequence of the process of manufacture of the product.

Subsection (1) of this section shall not be taken to be contravened by reason only that a substance has been added to, or abstracted from, the medicinal product, if it is proved that—

Where a medicinal product is sold or supplied in pursuance of a prescription given by an appropriate practitioner, the preceding provisions of this section shall have effect as if—

No person shall, in the course of a business carried on by him.— if that name is a name at the head of the relevant monograph and the product does not comply with the standard specified in that monograph.

No person shall, in the course of a business carried on by him, sell or supply a medicinal product which, in the course of that business, has been offered or exposed for sale and has been so offered or exposed for sale by, or by express reference to, a particular name, if that name is a name at the head of the relevant monograph and the product does not comply with the standard specified in that monograph.

Where a medicinal product is sold or supplied in the circumstances specified in subsection (1) or subsection (2) of this section, and the name in question is the name, not of the product itself, but of an active ingredient of the product, then for the purposes of the subsection in question the product shall be taken not to comply with the standard specified in the relevant monograph if, in so far as it consists of that ingredient, it does not comply with the standard so specified.

Subject to subsection (7) of this section, in this section " publication " means one of the following, that is to say, the British Pharmacopoeia, the British Pharmaceutical Codex, the British Veterinary Codex and any compendium published under Part VII of this Act; " the relevant monograph ", in relation to the sale or supply of a medicinal product which has been demanded, described in a prescription, or offered or exposed for sale, by or by express reference to a particular name.— and " current" means current at the time when the medicinal product in question is demanded, described in a prescription, or offered or exposed for sale, as mentioned in subsection (1) or subsection (2) of this section.

In this section " the appropriate current monograph ", in relation to a particular name, means—

Subject to subsection (8) of this section, for the purposes of this section an edition of a publication— and any monograph in an edition of a publication shall be construed in accordance with any general monograph or notice or any appendix, note or other explanatory material which is contained in that edition and is applicable to that monograph, and any reference in this section to compliance with the standard specified in a monograph shall be construed accordingly.

In relation to any time on or after the date on which, by notice published in the Gazette by or on behalf of the Health Ministers, it is declared that the European Pharmacopoeia prepared in pursuance of the Convention in that behalf done at Strasbourg on 22nd July 1964 is to have effect for the purposes of this section, subsections (1) and (2) of this section shall have effect as if, after the words " that name is ", in each place where those words occur, there were inserted the words " or is an approved synonym for, " subsection (4) of this section shall have effect as if, before the words "the British Pharmacopoeia ", there were inserted the words " the European Pharmacopoeia ", and after the words " headed by that name ", in each place where those words occur, there were inserted the words " or by a name for which it is an approved synonym ", and subsection (5) of this section shall have effect as if for paragraph (a) of that subsection there were substituted the following paragraphs:—.

For the purposes of this section, an edition of the European Pharmacopoeia— and a name shall be taken to be an approved synonym for a name at the head of a monograph in the European Pharmacopoeia if, by a notice so published and not withdrawn by any subsequent notice so published, it has been declared to be approved by the Medicines Commission as a synonym for that name.

The appropriate Ministers may by regulations prescribe such requirements as they may consider necessary or expedient with respect to any of the following matters, that is to say—

Without prejudice to the generality of the preceding subsection, regulations made under subsection (1) of this section may prescribe requirements in respect of—

The following provisions of this section shall have effect subject to sections 121 and 122 of this Act.

Any person who contravenes any of the following provisions of this Part of this Act, that is to say, sections 63 and 64, or who contravenes ... any order made under section 62 of this Act, shall be guilty of an offence.

Any person who gives a prescription or directions or administers a medicinal product in contravention of a condition imposed by an order under section 58 of this Act by virtue of subsection (4A) of that section shall be guilty of an offence.

Where a medicinal product is sold, supplied or imported in contravention of an order made under section 62 of this Act, any person who, otherwise than for the purpose of performing or exercising a duty or power imposed or conferred by or under this Act or any other enactment, is in possession of the medicinal product, knowing or having reasonable cause to suspect that it was sold, supplied or imported in contravention of the order, shall be guilty of an offence.

Any person who— shall be guilty of an offence.

Any person guilty of an offence under subsection (1A), (1B), (2) or (3) of this section shall be liable—

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Where in proceedings brought by an enforcement authority a person is convicted of an offence under section 67(6) of this Act in respect of any premises used for carrying on a retail pharmacy business, then on the application of that authority the court by or before which he was convicted may (subject to the following provisions of this section) make an order disqualifying him from using those premises for the purposes of such a business for such period, not exceeding two years, as may be specified in the order.

The court shall not make an order under this section disqualifying a person in respect of any premises unless the court thinks it expedient to do so having regard—

No order under this section shall be made against a person on the application of an enforcement authority unless the authority have, not less than fourteen days before the date of the hearing, given him notice in writing of their intention to apply for such an order to be made against him.

If, while an order under this section disqualifying a person hi respect of any premises is in force, the premises are used for the purposes of a retail pharmacy business carried on by him, he shall be guilty of an offence and liable on summary conviction to a fine not exceeding £400.

Subject to the next following subsection, at any time after the end of the period of six months from the date on which an order under this section comes into force, the person to whom the order relates may apply to the court by which the order was made to revoke the order or to vary it by reducing the period of disqualification.

On any application made under subsection (5) of this section the court may revoke or vary the order as mentioned in that subsection if it thinks it proper to do so having regard to all the circumstances of the case, including in particular the conduct of the applicant and any improvement in the state of the premises to which the order relates ; but, if on any such application the court refuses to revoke or vary the order, no further application made by the applicant under that subsection shall be entertained if it is made within three months from the date of the refusal.

The court to which an application under subsection (5) of this section is made shall have power to order the applicant to pay the whole or any part of the costs of the application.

In the application of this section to Scotland, for references to an enforcement authority and to costs there shall be substituted respectively references to the procurator fiscal and to expenses.

This section applies in a case where—

Where the defendant is charged with contravening section 63(a), it is a defence for the defendant to prove that—

Where the defendant is charged with contravening section 63(b), it is a defence for the defendant to prove that—

This section applies in a case where—

It is a defence for the defendant to prove that—

Condition A is that before the defendant was charged—

A defendant is a person within this subsection if the defendant is any of the following—

Condition B is that—

In subsection (5), “appropriate person” means any of the following—

This section applies in a case where a person (“the defendant”) is charged with an offence under section 67(2) of contravening section 64 in respect of a medicinal product.

It is a defence for the defendant to prove that—

Condition A is that before the defendant was charged—

A defendant is a person within this subsection if the defendant is any of the following—

Condition B is that—

In subsection (5), “appropriate person” means any of the following—

In this section, “the required nature or quality”, in relation to a product, means—

This section applies for the purposes of sections 67A to 67C.

If evidence is adduced that is sufficient to raise an issue with respect to the doing of an act by a person in the course of his or her profession, the court must assume that the person did that act in the course of his or her profession unless the prosecution proves the contrary beyond reasonable doubt.

The court must assume that the prosecution has proved the contrary beyond reasonable doubt if the prosecution proves beyond reasonable doubt that, in doing that act—

Proof that a registrant failed to comply with a procedure established in relation to a registered pharmacy or a relevant pharmacy service does not of itself constitute proof that the registrant was not acting in the course of his or her profession.

Knowledge acquired after a product is sold or supplied does not count if it is acquired only as a result of an investigation into whether an offence has been committed in respect of a product.

If evidence is adduced that is sufficient to raise an issue with respect to doing of an act promptly, the court must assume that the act was done promptly unless the prosecution proves the contrary beyond reasonable doubt.

A medicinal product is taken to be sold or supplied to a person in pursuance of a prescription or direction even if that person is not the person for whom it was dispensed in pursuance of the prescription or direction.

For the purposes of sections 67A to 67D a pharmacy service is a relevant pharmacy service if conditions A and B are met in respect of it.

Condition A is met in respect of a pharmacy service if—

Condition B is met in respect of a pharmacy service if it has a chief pharmacist.

A chief pharmacist, in relation to a pharmacy service, is a pharmacist who—

For the purposes of subsection (4)(c) a pharmacy service is carried on safely and effectively if it is carried on in ways that ensure its safe and effective running so far as concerns the sale or supply of medicinal products.

Subject to the provisions of any order made under section 73 of this Act, a person carrying on a retail pharmacy business shall be taken to be a person lawfully conducting such a business if, not being disqualified by virtue of section 80 of this Act,—

For the purposes of the application of this Part of this Act to a business which— each such part of that building shall be taken to be separate premises.

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In this Part of this Act— ... “the board”, in relation to a body corporate, means the body of persons controlling the body corporate, by whatever name called; ... “the register” means— in relation to Great Britain, the register established and maintained under article 19 of the Pharmacy Order 2010; and in relation to Northern Ireland, the register kept for the purposes of section 75; “the registrar” means— in relation to Great Britain, the person appointed under article 18 of the Pharmacy Order 2010 as registrar for the purposes of that Order; and in relation to Northern Ireland, the person appointed under Article 9(1) of the Pharmacy (Northern Ireland) Order 1976 as registrar for the purposes of that Order; “the relevant disciplinary committee” means— in relation to Great Britain, the Fitness to Practise Committee established under article 4(6) of the Pharmacy Order 2010; and in relation to Northern Ireland, the Statutory Committee appointed under Article 19 of the Pharmacy (Northern Ireland) Order 1976; “ relevant European State ” means either an EEA State other than the United Kingdom or Switzerland. ...

The conditions referred to in section 69(1)(a) of this Act are that subsections (2) and (3) of this section are both satisfied as respects each of the premises at or from which the retail pharmacy business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail.

This subsection is satisfied if a responsible pharmacist who satisfies the requirement of subsection (4) of this section is in charge of the business carried on at or from those premises, so far as concerns—

This subsection is satisfied if a notice is conspicuously displayed at those premises stating—

The responsible pharmacist must be—

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The conditions referred to in section 69(1)(b) of this Act are—

This subsection is satisfied if a responsible pharmacist who satisfies the requirement of subsection (4) of this section is in charge of the business carried on at or from the premises mentioned in subsection (1)(b) of this section, so far as concerns—

This subsection is satisfied if a notice is conspicuously displayed at those premises stating—

The responsible pharmacist must be—

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The requirements referred to in subsection (1)(a) of this section in relation to a superintendent are that—

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For the purposes of subsection (6)(aa), a person is a senior manager of a retail pharmacy business if the person plays a significant role (irrespective of whether other individuals also do so) in—

If a person who has been the superintendent in relation to a retail pharmacy business ceases to be the superintendent in relation to the business (otherwise than by reason of death) the person must notify the registrar in writing of that fact within the period of 28 days beginning with the day on which the person ceases to be the superintendent in relation to the business.

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The provisions of this section shall have effect where a pharmacist carries on a retail pharmacy business and— and a representative of his thereafter carries on his business.

The conditions referred to in section 69(1)(c) of this Act are—

In subsection (1)(c), the reference to a person who lacks capacity to carry on the business is to a person— and in relation to whom the donee or deputy has power for the purposes of this Act.

The period referred to in section 69(1)(c) of this Act— or, in any such case, is such longer period as, on the application of the representative, the relevant disciplinary committee, having regard to all the circumstances of the case, may direct.

In this section “representative”—

This subsection is satisfied if a responsible pharmacist is in charge of the business carried on at or from the premises mentioned in subsection (2)(b) of this section, so far as concerns—

This subsection is satisfied if a notice is conspicuously displayed at those premises stating—

The ... Ministers may by order add to, revoke or vary any of the provisions of sections 70 to 72 of this Act, so as either—

Any provision made by an order in accordance with subsection (1) of this section may be made either generally or in relation to any particular circumstances specified in the order.

Any order made under this section may direct that subsection (1) or subsection (2) of section 69 of this Act shall have effect subject to such exceptions or modifications as appear to the ... Ministers to be necessary or expedient in consequence of the provision made by the order in accordance with subsection (1) of this section.

Where an order under this section is for the time being in force, any reference to section 69 of this Act in any other enactment as amended by this Act shall be construed as a reference to that section as modified by the order.

No order shall be made under this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

Nothing in this Part is to be taken as requiring there to be a responsible pharmacist in respect of premises at or from which a retail pharmacy business is carried on at a time when no medicinal products (whether they are on a general sale list or not) are being—

It is the duty of the responsible pharmacist mentioned in sections 70, 71 and 72 of this Act to secure the safe and effective running of the pharmacy business carried on at or from the premises in question so far as concerns—

A person may not be the responsible pharmacist in respect of more than one set of premises at the same time, except in circumstances specified by the General Pharmaceutical Council in rules in relation to premises in Great Britain or the Council of the Pharmaceutical Society of Northern Ireland in regulations in relation to premises in Northern Ireland, and then only if such conditions as may be so specified are complied with.

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The General Pharmaceutical Council may make further provision in rules in relation to the responsible pharmacist in respect of premises in Great Britain, and the Council of the Pharmaceutical Society of Northern Ireland may make further provision in regulations in relation to the responsible pharmacist in respect of premises in Northern Ireland.

In making any such provision, the General Pharmaceutical Council and the Council of the Pharmaceutical Society of Northern Ireland must have regard to the principle that the burdens imposed on businesses by rules or regulations should be the minimum necessary to secure the benefits, considered in general terms, which are expected to result from the rules or regulations.

The rules and regulations mentioned in subsection (6) may (amongst other things)—

If such rules or regulations make provision about the responsible pharmacist’s absence from the premises, they must also provide that the retail sale of medicinal products on a general sale list may continue at or from the premises during any period in which the responsible pharmacist is absent from the premises.

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The failure by a person to comply with any requirements of section 72A or 72AA of this Act, or of rules or regulations made under section 72A, may constitute misconduct for the purposes of section 80 of this Act, article 51(1)(a) of the Pharmacy Order 2010 and Article 20 of the Pharmacy (Northern Ireland) Order 1976 and the relevant disciplinary committee may deal with such a failure accordingly.

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Subsection (4) of this section applies if a person—

If this subsection applies, the person in question is not to be considered while the failure continues as being in charge of the business carried on at or from the premises in question (or in a subsection (3)(a) case at any of them) for the purposes of sections 70 to 72 of this Act.

. . . In this Act “registered pharmacy” means premises for the time being entered in the register ....

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If the entry of a registered pharmacy in the register is suspended under paragraph (4)(b) of article 14 section 82A of this Act, paragraph 8 of Schedule 3 to the Pharmacy (Northern Ireland) Order 1976 or article 14(4)(b) or 56 of the Pharmacy Order 2010 then, except for such purposes of that Order as the General Pharmaceutical Council may prescribe by rules in relation to Great Britain or the Council of the Pharmaceutical Society of Northern Ireland may prescribe by regulations in relation to Northern Ireland, that registered pharmacy must be treated as not being entered in the register notwithstanding that the register still includes the address of that pharmacy.

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Accordingly, premises whose entry in the register is suspended are not to be treated as a registered pharmacy for the purposes of this Act or any other enactment apart from that Order except for a purpose prescribed by the rules or regulations mentioned in subsection (1A) .

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It shall be the duty of the registrar to keep a register for the purposes of this section ... and, subject to the following provisions of this section, on payment of the prescribed fee to enter in the register any premises in respect of which an application is made under this section.

This section applies in relation to premises in Northern Ireland.

Any application for the registration of premises under this section shall be made in the prescribed manner and shall specify the premises to which the application relates and shall contain such other particulars as may be prescribed.

On the making of any such application the registrar shall notify the appropriate Minister, specifying the premises to which the application relates and the date on which the application was made, and shall not enter those premises in the register before the end of the period of two months from that date, unless before the end of that period the appropriate Minister consents to his doing so.

If it appears to the appropriate Minister that in a material respect the premises do not comply with the requirements of regulations made under section 66 of this Act which are for the time being in force, and accordingly he proposes to certify that the premises are unsuitable for registration under this section, he shall, before the end of the period referred to in subsection (3) of this section, serve on the applicant a notice stating his proposals and the reasons for them, and shall serve a copy of that notice on the registrar; and, where a copy of such a notice is served on him, the registrar shall not enter the premises in the register except where required to do so in accordance with the following provisions of this section.

If, within the time allowed after the service on him of a notice under subsection (4) of this section, the applicant gives notice to the appropriate Minister of his desire to be heard with respect to the proposals, or makes representations in writing to the appropriate Minister with respect to the proposals, then, before determining whether to issue a certificate under this section in respect of the premises,—

Where the appropriate Minister has served a notice under subsection (4) of this section, then—

Notwithstanding anything in the preceding provisions of this section, the registrar shall not enter any premises in the register in pursuance of an application under this section unless it is shown to his reasonable satisfaction either—

In this section “the appropriate Minister”— and “the time allowed” means the period of twenty-eight days or such extended period as the appropriate Minister may in any particular case allow.

This section applies in relation to premises in Great Britain.

If the registrar is satisfied that the conditions in section 74B are met in relation to premises that are not entered in the register, the registrar must enter the premises in Part 3 of the register unless the registrar considers that doing so would prejudice the health, safety or well-being of members of the public.

Subject to subsection (5) and to section 74H, the entry of premises entered in Part 3 of the register under subsection (2) is valid for the period of one year beginning with the date on which the entry was made.

If the registrar is satisfied that the conditions in section 74B are met in relation to premises entered in Part 3 of the register under subsection (2), the registrar must renew the entry of the premises unless the registrar considers that doing so would prejudice the health, safety or well-being of members of the public.

Subject to subsection (7) and to section 74H, each renewal of the entry of premises entered in Part 3 of the register under subsection (2) extends the validity of the entry for the period of one year beginning with the day on which the entry would otherwise have ceased to be valid.

The registrar may, except in such circumstances as may be prescribed by the General Pharmaceutical Council in rules, renew the entry of premises in Part 3 of the register for a period exceeding one year beginning with the day on which the entry would otherwise have ceased to be valid in which case the renewal of the entry of premises entered in that part of the register under subsection (2) extends the validity of the entry for that period.

If the entry of premises entered in Part 3 of the register under this section ceases to be valid then, except in such circumstances as may be prescribed by the General Pharmaceutical Council in rules, the premises are to be treated for all purposes as no longer being entered in Part 3 of the register and accordingly the registrar must remove the entry from that part of the register.

Where any premises have been entered in the register under section 75, then, in respect of each year subsequent to the year in which the premises were so entered, a further fee (in this section referred to as a “retention fee") of the prescribed amount shall be payable by the person carrying on a retail pharmacy business at or from those premises.

If, on demand being made to him in the prescribed manner, the person carrying on a retail pharmacy business at or from any premises entered in the register under section 75 fails to pay a retention fee in respect of those premises within two months from the date on which the demand is made, the appropriate Minister may direct the registrar to remove the premises from the register; but if, before the end of the year in respect of which the retention fee is payable or such longer period as in any particular case the appropriate Minister may allow, the person carrying on the business pays to the registrar the retention fee in respect of that year, together with such additional sum (if any) by way of penalty as may be prescribed,—

Where a change occurs in the ownership of a retail pharmacy business carried on at or from any premises registered under section 75 of this Act, the registration of the premises under that section—

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Where the registration of any premises under section 75 of this Act in respect of a business becomes void by virtue of subsection (3) of this section, an application for the premises to be restored to the register may be made by the person who, in consequence of the change of ownership, has become the owner of the business; and where such an application is made, and it is shown to the reasonable satisfaction of the registrar either— and (in a case where, if the registration had not become void, a retention fee would have become payable) a fee equal to a retention fee has been paid, the registrar shall restore the premises to the register.

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A document purporting to be a certificate signed by the registrar and stating that, on a specified date, specified premises in Northern Ireland were, or were not, entered in the register shall be admissible in any proceedings as evidence (and, in Scotland, shall be sufficient evidence) that those premises were, or were not, entered in the register on that date.

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In this section—

The conditions referred to in section 74A are as follows.

Condition A is that an application for the entry of the premises in Part 3 of the register or, as the case may be, for the renewal of the entry of the premises in Part 3 of the register is made—

Condition B is that the appropriate fee prescribed in rules made by the General Pharmaceutical Council under article 36(1) of the Pharmacy Order 2010 is paid.

Condition C—

Condition D—

The registrar may restore to Part 3 of the register the entry of premises removed from that part of the register by virtue of section 74A(7) if an application is made to the registrar in accordance with this section.

An entry restored under this section to Part 3 of the register—

An application for restoration may be made to the registrar by the person who is the owner of the retail pharmacy business previously carried on at or from the premises and that person must be—

The General Pharmaceutical Council may make rules in connection with applications under this section.

Rules under subsection (4) may, in particular, include provision—

Where the registrar restores the entry of premises to Part 3 of the register pursuant to an application under this section, the registrar must give notice in writing of that restoration to the applicant.

The notice under subsection (6) must specify—

The notice under subsection (6) must be sent—