Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
| Jurisdiction | UK Non-devolved |
| Citation | SI 1994/3144 |
1994 No. 3144
MEDICINES
The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
Made 8th December 1994
Laid before Parliament 9th December 1994
Coming into force 1st January 1995
The Secretary of State, in exercise of the powers conferred by section 2(2) of the European Communities Act 19721, being designated for the purpose of that section in relation to medicinal products2, hereby makes the following Regulations:
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)
(a) in the case of all of these Regulations, immediately after the coming into force of Council Regulation (EEC) No. 2309/933and Council Directive 93/39/EEC4; and also
(b)
(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 19945.
(2) In these Regulations:
“the Act” means the Medicines Act 19686; “the Community” means the European Community;
“Community marketing authorization” means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/937;
“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/EEC8;
Council Directive 75/318/EEC9;
Chapters I to II and V to VI of Council Directive 75/319/EEC10and any Regulation adopted by the Commission under Article 15 of that Directive;
Council Directive 89/342/EEC11;
Council Directive 89/343/EEC12;
Council Directive 89/381/EEC13;
Council Directive 92/26/EEC14;
Council Directive 92/27/EEC15;
Council Directive 92/73/EEC16;
Regulation (EEC) No. 2309/9317and 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/EECapply, 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)
(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 197118relate and has been manufactured or assembled only for sale or supply in those circumstances; or
(b)
(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)
(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)
(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)
(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 197819shall 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)
(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)
(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)
(a) no relevant medicinal product shall be placed on the market; and
(b)
(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)
(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)
(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...
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