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Statutory Instrument 1993 No. 2538
The Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993
(The document as of February, 2008)
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STATUTORY INSTRUMENTS
1993 No. 2538
MEDICINES
The Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993
| Laid before Parliament | 28th October 1993 |
| Coming into force | 29th November 1993 |
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred upon them by sections 18, 129(1) and (5) and 132(1) of the Medicines Act 1968[1] or, as the case may be, those conferred by the said provisions and now vested in them[2] and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations[3], hereby make the following Regulations: Citation, commencement and interpretation
1.—(1) These Regulations may be cited as the Medicines (Applications for Grant of Product Licences-Products for Human Use) Regulations 1993, and shall come into force on 29th November 1993.
(2) In these Regulations—
"the Act" means the Medicines Act 1968;
"application", except in regulation 2 below and in sub-paragraph (a) of paragraph 6 of Schedule 2, means an application to which these Regulations apply by virtue of that regulation;
"the Directives" means the Directives made by, as the case may be, the Council or Commission of the European Economic Community, numbered 75/318/EEC[4], 75/319/EEC[5], 89/342/EEC[6] and 89/381/EEC[7] and any reference to any of those Directives is to the Directive as in force immediately before the date on which these Regulations are made;
"expert" means an expert with suitable technical or professional qualifications and experience for the purposes of drawing up any description or particulars referred to in paragraphs 7 and 8 of, or any report referred to in paragraph 12 of, Schedule 1;
"product"means any medicinal product and any other article, product or substance in relation to which section 7(2) of the Act for the time being has effect (with or without modification) as it has effect in relation to medicinal products, by virtue of an order under section 104 or 105 of the Act made before the date on which these Regulations were made or regulations under section 2(2) of the European Communities Act 1972[8] made before that date.
(3) Expressions used in these Regulations which are also used in any relevant Community Directive[9] shall, except where the contrary intention appears and except in the case of "medicinal product", have the same meaning as they have in the relevant Directive, and related expressions shall be construed accordingly.
(4) Any reference in these Regulations to a numbered Schedule is a reference to the Schedule to these Regulations bearing that number.
Application of these Regulations
2.—(1) Subject to paragraph (2) below, these Regulations shall apply to any application, made after the coming into force of these Regulations, for the grant (but not renewal) of a product licence in relation to a product for human use.
(2) These Regulations shall not apply where the application is one which is deemed to be an application by virtue of section 18(3) of the Act.
Manner of applications
3.—(1) Every application shall be made in writing and shall be signed by or on behalf of the applicant.
(2) 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.
(3) A separate application shall be made in respect of each product of a particular description, except that a single application may be made— (a) in respect of two or more products which have the same pharmaceutical form and either consist of the same single active constituent in different strengths, or consist of a mixture in different strengths of the same two or more active constituents in the same proportion; (b) in respect of two or more substances or two or more articles having the same physical form and either having the same single active constituent in different strengths or being a mixture in different strengths of the same two or more active constituents in the same proportion; (c) in the case of homoeopathic products and products using similar attenuations, in respect of— (i) two or more attenuations of the same mother tincture or other solution of the same trituration, or (ii) two or more attenuations of any mother tincture or other solution or trituration having the same specification and pharmaceutical form apart from the tincture, solution or trituration; (d) in the case of products being preparations of allergen extracts for the treatment of allergies, in respect of two or more attenuations of the same allergen extract or of the same mixture of allergen extracts; or (e) in the case of products for testing for allergic responses to specific substances in respect of two or more allergen extracts manufactured by one and the same method, provided that the application states the substances from which the extracts are prepared.
Material to be contained in or accompany an application
4.—(1) Subject to paragraphs (4), (5), (6) and (7) below, an application which relates to any product to which Chapters II to V of the 1965 Directive apply shall, in respect of each such product, contain or be accompanied by such of the information, documents, samples and other material specified in Schedule 1 as relate to the product, prepared and presented in accordance with the applicable requirements of the Directives.
(2) Subject to paragraphs (4) and (7) below, an application which relates to any product which is not a product to which Chapters II to V of the 1965 Directive apply shall, in respect of each such product, contain or be accompanied by such of the information, documents, samples and other material specified in Schedule 1 as relate to the product, prepared and presented in accordance with such of the requirements of the Directives as would be applicable to the product if it were a product to which those Chapters applied.
(3) Schedule 2 (which sets out exceptions to the requirements to provide the particulars of various tests and trials) shall have effect for the purposes of paragraph 8 of Schedule 1.
(4) Schedule 3 (under which certain particulars may, in certain circumstances, be provided otherwise than by the applicant) shall have effect.
(5) Insofar as an application relates to a product which has been, or is to be, imported into the United Kingdom and in respect of which a marketing or equivalent authorisation is in force elsewhere than in the United Kingdom, it need not contain or be accompanied by any material which, in accordance with Community obligations, may not be required by the competent authorities of a member State as a condition of granting a marketing authorisation.
(6) Where paragraph (5) above has effect in relation to any product, the application shall, in addition to any other material required by these Regulations, contain or be accompanied by information sufficient to identify the relevant marketing or equivalent authorisation and any relevant United Kingdom product licence, and shall be accompanied by a sample of the product complete with the outer packaging, immediate packaging and labels all in the form as marketed in the member or other State where the relevant marketing or equivalent authorisation is in force.
(7) The requirements of Part 2, paragraph A, point 3.3 of the Annex to Directive 75/318/EEC[10] shall not apply in relation to an application made before 1st January 1995.
Amendment of the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971
5. In regulation 2(1) (interpretation) of the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971[11], at the end of the definition of "application", there shall be inserted the words "or a request for the grant of a product licence, being a request which is an application to which the Medicines (Applications for Grant of Product Licences-Products for Human Use) Regulations 1993 apply".
Signed by authority of the Secretary of State for Health
Tom Sackville
Parliamentary Under Secretary of State Department of Health
15th October 1993
John Redwood
Secretary of State for Wales
19th October 1993
Fraser of Carmyllie
Minister of State, Scottish Office
15th October 1993
In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on
18th October 1993.
Gillian Shephard
Minister of Agriculture, Fisheries and Food
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on
21st October 1993.
F. A. Elliott
Permanent Secretary
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on
18th October 1993.
W. J. Hodges
Permanent Secretary
Notes:[1] 1968 c. 67. The expression "the Ministers", used in section 129(1), is defined in section 1(1) of that Act as amended by S.I.1969/388, Schedule 1. Section 132(1) is cited for the definition of "prescribed".
[2] In the case of the Secretaries of State concerned with health in England and in Wales by virtue of Article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I.1969/388); in the case of the Secretary of State concerned with agriculture in Wales by virtue of Article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I.1978/272); in the case of the Northern Ireland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) ofSchedule 1 to, the Northern Ireland Act 1974 (c. 28).
[3] (See section 129(6) of the Medicines Act 1968 (c. 67).
[4] OJ No.L147, 9.6.75, p.1. The Directive was amended by Directive 89/341/EEC (OJ No.L142, 25.5.89, p.11), and the Annex to it was substituted by Directive 91/507/EEC (OJ No.L270, 26.9.91, p.32).
[5] OJ No.L147, 9.6.75, p.13.
[6] OJ No.L142, 25.5.89, p.14.
[7] OJNo.L181, 28.6.89, p.44.
[8] 1972 c. 68.
[9] The principal relevant Directives are Directive 65/65/EEC (OJ No.22, 9.2.65, p.369/65 (OJ/SE1965-66, p.20) as amended, the Directives included in the definition of "the Directives" in regulation 1(2) above and Directive 89/343/EEC (OJ No. L142, 25.5.89, p. 16). For present purposes, the relevant Directives amending Directive 65/65/EEC are: 75/319/EEC (OJ No.L147, 9.6.75, p.13), 83/570/EEC (OJNo.L332, 28.11.83, p.1), 87/21/EEC (OJ No.L15, 17.1.87, p.36) and 89/343/EEC, amending and supplementing Article 4; and 83/570/EEC, inserting Article 4a, and 89/341/EEC (OJ No.L142, 25.5.89, p.11), 89/342/EEC (OJ No.L142, 25.5.89, p.14) and 89/343/EEC, amending and supplementing that Article.
[10] OJ No.L147, 9.6.75, p.1. A new Annex was substituted by Directive 91/507/EEC (OJ No.L270, 26.9.91, p.32).
[11] S.I.1971/973.
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