The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 and shall come into force on 1st January 1995—

(a) in the case of all of these Regulations, immediately after the coming into force of Council Regulation (EEC) No. 2309/93(1) and Council Directive 93/39/EEC(2); and also

(b) in the case of paragraphs 4, 5 and 6 of Schedule 7, immediately after the coming into force of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994(3).

(2) In these Regulations:

“the Act” means the Medicines Act 1968(4); “the Community” means the European Community;

“Community marketing authorization” means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93(5);

“the EMEA” means the European Agency for the Evaluation of Medicinal Products established by Council Regulation (EEC) No. 2309/93;

“parallel import” means the import into the United Kingdom from another Member State of the Community of a medicinal product for human use in respect of which there has been granted a Community marketing authorization or a marketing authorization by another Member State of the Community and which has no difference having therapeutic effect from a medicinal product in respect of which a marketing authorization has previously been granted in the United Kingdom;

“the relevant Community provisions” means the provisions of—

• Council Directive 65/65/EEC(6);

• Council Directive 75/318/EEC(7);

• Chapters I to II and V to VI of Council Directive 75/319/EEC(8) and any Regulation adopted by the Commission under Article 15 of that Directive;

• Council Directive 89/342/EEC(9);

• Council Directive 89/343/EEC(10);

• Council Directive 89/381/EEC(11);

• Council Directive 92/26/EEC(12);

• Council Directive 92/27/EEC(13);

• Council Directive 92/73/EEC(14);

• Regulation (EEC) No. 2309/93(15) and any Regulations adopted by the Commission under Article 15.4 or 22.1 of that Regulation,

as they have effect on the day these Regulations come into force;

“relevant medicinal product” means a medicinal product for human use to which Chapters II to V of Council Directive 65/65/EEC apply, and accordingly includes the industrially produced medicinal products mentioned in Article 2.2 of that Directive; and

“United Kingdom marketing authorization” means a marketing authorization granted by the licensing authority under these Regulations.

(3) For the purposes of the definition of “relevant medicinal product” in paragraph (2) a medicinal product which is a herbal remedy is not industrially produced if—

(a) it is, or is to be, sold or supplied in circumstances to which either section 12(1) of the Act or Article 2 of the Medicines (Exemptions from Licences) (Special and Transitional Cases) Order 1971(16) relate and has been manufactured or assembled only for sale or supply in those circumstances; or

(b) the process to which the plant or plants are subjected in producing the product consists only of drying, crushing or comminuting, and the product is, or is to be, sold or supplied only as provided by section 12(2) of the Act.

(4) Except where the contrary intention appears—

(a) any reference in these Regulations to a marketing authorization includes a reference both to a United Kingdom marketing authorization (including a product licence having effect as such an authorization) and to a Community marketing authorization;

(b) any reference in these Regulations to the variation of a marketing authorization includes a reference to a change in the requirements for labels or package leaflets; and

(c) any reference in these Regulations to an application for the grant or renewal of a marketing authorization is a reference to an application made after the coming into force of these Regulations.

(5) Expressions used in these Regulations which are also used in any of the relevant Community provisions shall, except where the contrary intention appears, and except in the case of ‘clinical trial’, have the same meaning as they have there, and related expressions shall be construed accordingly.

(6) Subject to paragraph (5), section 11 of the Interpretation Act 1978(17) shall apply for the interpretation of these Regulations as if they were made in the exercise of a power conferred by the Act.

(7) In these Regulations—

(a) any reference to a numbered regulation or to a numbered Schedule is a reference to the regulation of or Schedule to these Regulations bearing that number; and

(b) any reference in a regulation or Schedule to a numbered paragraph is a reference to the paragraph of that regulation or Schedule bearing that number.

Responsibility for Member States' functions under the Regulations and Directives

2.—(1) In so far as they relate to relevant medicinal products and fall to be performed by, or by any authority of, the United Kingdom, the functions of a Member State, or of the competent authority of a Member State, under any of the relevant Community provisions shall, subject to paragraph (2), be performed by the licensing authority.

(2) Paragraph (1) shall not apply in so far as any such functions fall to be performed by the exercise of any powers or duties which are conferred by any provision of these Regulations, or by any provision of the Act as applied by these Regulations, on a person or body other than the licensing authority.

Marketing authorizations for relevant medicinal products

3.—(1) Except in accordance with any exception or exemption set out in the relevant Community provisions and subject to paragraphs 1 and 3 of Schedule 1—

(a) no relevant medicinal product shall be placed on the market; and

(b) no such product shall be distributed by way of wholesale dealing,

unless a marketing authorization in respect of that product has been granted in accordance with the relevant Community provisions by the licensing authority or the European Commission, and is for the time being in force in accordance with those provisions.

(2) Schedule 1 shall have effect for the purpose of making certain exceptions or exemptions from paragraph (1), and for imposing certain obligations in connection with such exceptions and exemptions.

Applications for the grant, renewal or variation of a United Kingdom marketing authorization

4.—(1) Every application for the grant, renewal or variation of a United Kingdom marketing authorization for a relevant medicinal product shall be made in accordance with the relevant Community provisions, subject to any provision of Community law affecting parallel imports, and the applicant shall comply with so much of the relevant Community provisions as impose obligations on applicants as are applicable to the application or the consideration of it.

(2) Every application shall be made in writing, shall be signed by or on behalf of the applicant and shall, unless the licensing authority otherwise direct, be accompanied by any fee which may be payable in connection with that application.

(3) In the case of an application for the grant of a marketing authorization, twenty-six copies, or such lesser number as the licensing authority may direct, of each application and of any accompanying material shall be supplied to the licensing authority in the English language, and where the application or any accompanying material has been translated from another language, also one copy of the application or the accompanying material, as the case may be, in the original language.

(4) In the case of an application for the renewal of a marketing authorization, three copies of each application and of any accompanying material shall be supplied to the licensing authority, but in all other respects the applicant shall comply with the provisions of paragraph (3).

(5) An application for the grant of a marketing authorization shall include a statement indicating—

(a) whether the relevant medicinal product is one that should be available—

(i) only on prescription;

(ii) only from a pharmacy; or

(iii) on general sale; and

(b) what, if any, provisions of the authorization are proposed concerning the method of sale or supply of the product (including, in particular, any proposed restrictions affecting the circumstances of the use or promotion of the product).

(6) For the purposes of point 8(a)(iii) of the second paragraph of Article 4 of the 1965 Directive, the period of 10 years there mentioned (period during which essentially similar products must have been on the market) shall apply to all relevant medicinal products.

(7) An applicant shall not be entitled by virtue of point 8(a) of the second paragraph of Article 4 of the 1965 Directive to omit to provide any particulars or results if proper consideration of the application without them could not be carried out without prejudicing any rights which arise under any law relating to the protection of industrial and commercial property and which are enforceable in the United Kingdom.

(8) The applicant for the grant or renewal of a United Kingdom marketing authorization must be established in the Community.

(9) An application for the renewal of a marketing authorization shall be made not later than 3 months before the date on which the existing authorization expires.

Consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization.

5.—(1) The licensing authority shall consider every application for the grant, renewal or variation by them of a marketing authorization in accordance with the relevant Community provisions, and shall grant, renew or vary, or refuse to grant, renew or vary the authorization in accordance with those provisions.

(2) The licensing authority shall publish in the Gazette(18) notice of every authorization granted by them.

(3) Schedule 2 shall have effect to regulate the procedure for receiving advice and representations before granting, renewing or varying, or refusing to grant, renew, or vary, a marketing authorization.

(4) A marketing authorization shall, unless previously renewed or revoked, be valid for the period (not exceeding five years) specified in it beginning with the date on which it is granted, but where an application for the renewal of such an authorization is made in accordance with Article 10 of the 1965 Directive the marketing authorization shall remain in force pending the decision of the licensing authority on that application.

Revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products.

6.—(1) The licensing authority may and, where appropriate shall, subject to and in accordance with the relevant Community provisions, revoke, suspend or vary a marketing authorization for a relevant medicinal product.

(2) The licensing authority may and, where appropriate, shall, subject to paragraph (3) and subject to and in accordance with the relevant Community provisions, by notice in writing to the holder of a marketing authorization for a relevant medicinal product, forthwith or from a date specified in the notice, suspend the use, supply or marketing within the United Kingdom of the product to which the authorization relates for a period specified in the notice.

(3) In any case where the relevant Community provisions permit or require the suspension of the use, supply or marketing of a product until some decision or similar action is taken by the Community, the licensing authority may, instead of specifying a period in the notice, provide that the suspension is to apply until further notice.

(4) Where the licensing authority, in accordance with paragraph (3) include a provision that the suspension is to apply until further notice, they shall, where the effect of the Community decision or action is that the product may continue to be used or, as the case may be, marketed, in the United Kingdom, promptly give the holder of the authorization written notice revoking the suspension forthwith or from such date specified in the notice as to comply with that decision or action.

(5) Where, under the preceding provisions of this regulation or the provisions of Council Regulation (EEC) No. 2309/93, the licensing authority or the European Commission revoke or suspend a marketing authorization, or where the licensing authority suspend the use, supply or marketing of a product, or where the relevant Community provisions so permit or require, the licensing authority may and, where appropriate, shall give written notice to the person who is or, immediately before its revocation or suspension, was the holder of the authorization, requiring him to take all reasonably practicable steps to—

(a) inform wholesalers, retailers, medical practitioners, patients and others who may be in possession of relevant products of the revocation or suspension, the reasons for it, and the action (if any) to be taken to restrict or prevent further use, supply or marketing;

(b) withdraw from the market in the United Kingdom and recover possession of such products within the time and for the period specified in the notice.

(6) The licensing authority may require the holder of the marketing authorization to withdraw from the market in the United Kingdom specified batches only of a product to which a notice under paragraph (5) applies.

(7) Schedule 2 shall have effect to regulate the procedure for receiving advice and representations before revocation, variation (otherwise than on the application of the holder) or suspension of a marketing authorization, and for notifying the holder of that authorization in accordance with the preceding provisions of this regulation.

(8) The licensing authority shall publish in the Gazette notice of every decision by them to revoke an authorization.

Obligations of holders of marketing authorizations, and offences by holders of marketing authorizations and other persons

7.—(1) Every holder of a United Kingdom marketing authorization for a relevant medicinal product shall comply with all obligations which relate to him by virtue of the relevant Community provisions (apart from Regulation (EEC) No. 2309/93) including, in particular, obligations relating to providing or updating information, to making changes, to applying to vary the authorization, to pharmacovigilance, and to labels and package leaflets.

(2) The holder of a marketing authorization shall maintain a record of reports of which he is aware of suspected adverse reactions in accordance with the relevant Community provisions which shall be open to inspection by a person authorised by the licensing authority, who may take copies of the record and, if the licensing authority so directs, the authorization holder shall furnish the licensing authority with a copy of any such reports of which he has a record or of which he is or subsequently becomes aware.

(3) The holder of a marketing authorization shall keep such documents as will facilitate the withdrawal or recall from sale or supply of any relevant medical product to which the authorization relates.

(4) Schedule 3 shall have effect to create certain criminal offences in connection with the obligations of applicants for, and holders of, marketing authorizations and other persons arising under the relevant Community provisions.

(5) Where, by or under any provision of the relevant Community provisions or of these Regulations, a person is required to provide any information or furnish any document to the licensing authority and no time is specified in that provision within which that obligation is to be performed, it shall be performed within such time as may be specified in a written notice served on that person by the licensing authority.

(6) The holder of a marketing authorization granted or renewed after the coming into force of these Regulations must be established in the Community.

Control of retail sale of supply of relevant medicinal products

8.—(1) Paragraphs (2) or (3) applies where a Community marketing authorization for a relevant medicinal product is subject to any condition or restriction which attaches to the authorization under Article 9.3(b) of Council Regulation (EEC) No. 2309/93.

(2) If the condition or restriction is to the effect that the product is to be sold or supplied only in accordance with a prescription given by a person who, in relation to the product, is an appropriate practitioner for the purposes of section 58 of the Act, the appropriate Ministers shall, subject to Article 3.4 of Council Directive 92/26/EEC (power to waive the application of the other provisions of that Article), give effect to the condition or restriction—

(a) by exercising their powers under section 58 or 60 of the Act; or

(b) where it appears to them that such an exercise would not be immediately practicable, by means of a written direction addressed to the holder of the authorization.

(3) If the condition or restriction is not to that effect, the appropriate Ministers shall give effect to it—

(a) by the exercise of any other statutory power available to them for that purpose; or

(b) if there is no such power, by means of a written direction addressed to the holder of the authorization.

(4) Except as provided by paragraph (2), the appropriate Ministers shall not exercise their powers under section 58(1) or, subject to paragraph (5), section 60 of the Act in relation to any relevant medicinal product for which a Community marketing authorization has been granted.

(5) Paragraph (4) does not prevent the appropriate Ministers from exercising their powers under section 60 of the Act for the purposes mentioned in subsection (2) of that section.

Consequential and other amendments of the Act and the Medicines Act 1971

9.—(1) —Sections 3 and 4 of the Act shall have effect as if any reference to the Act included a reference to these Regulations.

(2) Section 7 of the Act (dealing with medicinal products and product licences) shall not apply in relation to relevant medicinal products.

(3) Section 23 of the Act (special provisions as to the effect of manufacturer’s licence) shall have effect as if any reference in subsection (1) to a product licence included a reference to a marketing authorization.

(4) Section 58A of the Act (requirement to specify certain products for human use as prescription-only products) shall have effect as if in subsection (1)—

(a) the reference to section 58(1) of the Act included a reference to section 60(1) of the Act;

(b) the reference to a product licence included a reference to a marketing authorization;

(c) the reference to the descriptions or classes specified for the purposes of section 58 of the Act included a reference to the descriptions or classes specified in regulations under section 60 of the Act.

(5) Section 59 of the Act (special provisions in relation to new medicinal products) shall have effect as if—

(a) any reference to a product licence granted under Part II of the Act included a reference to a marketing authorization granted under these Regulations; and

(b) any reference to a product licence included a reference to such an authorization.

(6) Section 61 of the Act (special restrictions on persons to be supplied with medicinal products) shall have effect as if the reference to a product licence included a reference to a marketing authorization.

(7) Section 92 of the Act (scope of Part VI) shall have effect as if—

(a) any reference in subsection (4) to a licence under Part II of the Act included a reference to a marketing authorization; and

(b) the reference in that subsection to being engaged, in relation to medicinal products of the description in question, in any such activities as are referred to in that subsection included a reference to being engaged in putting medicinal products of that description on the market.

(8) Section 103 of the Act (construction of references to specified publications) shall have effect as if any reference in subsection (2) to a licence granted under the Act included a reference to a marketing authorization.

(9) The following provisions of the Act, namely—

(a) the provisions amended by paragraphs (3) to (8); and

(b) the other provisions of Parts III, VI and VII of the Act,

shall have effect as if all relevant medicinal products were medicinal products for the purposes of the Act (whether or not they would otherwise be so).

(10) In relation to any medicinal product to which section 58A of the Act applies by virtue of paragraph (4) and in respect of which a Community marketing authorization has been granted—

(a) that section shall have effect as if subsections (3) and (4) were omitted;

(b) section 58 of the Act (medicinal products on prescription only) shall have effect as if subsection (6) were omitted;

(c) section 60 of the Act (restricted sale, supply and administration of certain medicinal products) shall have effect as if subsection (7) were omitted;

(d) each of those sections shall have effect subject to the provisions of paragraph (4) of regulation 8 above; and

(e) section 129 of the Act (orders and regulations) shall have effect as if subsection (6) were omitted.

(11) The provisions of the Trade Description Act 1968(19) shall apply to the application of a trade description to goods subject to a marketing authorization in the same way as, by virtue of section 2(5)(b) of that Act, they apply to the application of a trade description to goods subject to any provision made under Part V of the Act.

(12) Section 1 of the Medicines Act 1971(20) (fees payable for purposes of Part II of the Act) shall have effect as if—

(a) in subsection (1), the reference to any application in pursuance of the Act for a licence under Part II of the Act or for the variation or renewal of such a licence included a reference to any application under these Regulations for a marketing authorization or for the variation or renewal of such an authorization; and

(b) in subsection (2)(b), any reference to a licence under Part II of the Act included a reference to a marketing authorization under these Regulations.

(13) Section 19 of the Consumer Protection Act 1987(21) (interpretation of Part II) shall have effect as if in subsection (1) in the definition of “licensed medicinal product”, the reference to any medicinal product within the meaning of the Medicines Act 1968 in respect of which a product licence within the meaning of that Act is for the time being in force, included a reference to a relevant medicinal product in respect of which a United Kingdom marketing authorisation under these Regulations or a Community marketing authorisation is for the time being in force.

(14) Section 1 of the Food Safety Act 1990(22) (meaning of “food” and other basic expressions) shall have effect as if in paragraph (d)(i) of subsection (2), the reference to medicinal products within the meaning of the Medicines Act 1968 in respect of which product licences within the meaning of that Act are for the time being in force, included a reference to relevant medicinal products in respect of which United Kingdom marketing authorizations under these Regulations or Community marketing authorizations are for the time being in force.

Application of enforcement provisions of the Act

10.—(1) Subject to paragraph (2) below, the following provisions of Part VIII of the Act (which provide for enforcement of the Act), namely, sections 107 to 109, section 110 except subsection (4), sections 111 to 116, section 118, section 119, sections 121 to 127 and Schedule 3, shall apply for the purposes of these Regulations as they apply for the purposes of the Act.

(2) Those provisions as so applied shall have effect—

(a) with the modifications specified in Schedule 4 to these Regulations; and

(b) as if all relevant medicinal products were medicinal products for the purposes of the Act (whether or not they would otherwise be so).

Other Schedules to have effect

11.  The following Schedules shall have effect, namely Schedule 5 (labels), Schedule 6 (transitional provisions) and Schedule 7 (consequential amendments to regulations).

Signed by authority of the Secretary of State for Health

Tom Sackville

Parliamentary Under Secretary of State,

Department of Health

8th December 1994