The Medicines (Codification Amendments Etc.) Regulations 2002

Amendment of the Marketing Authorisations Regulations 1994

8.  The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(1) are amended as follows—

(a) in regulation 1(2) (interpretation)—

(i) after the definition of “Community marketing authorization” there is inserted the following definition—

““the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use(2)”,

(ii) for the definition of “the relevant Community provisions” there is substituted—

““the relevant Community provisions” means the provisions of—

the 2001 Directive;

Regulation (EEC) No. 2309/93(3);

Regulation (EC) No. 540/95(4);

Regulation (EC) No. 541/95(5), as amended(6);

Regulation (EC) No. 542/95(7), as amended(8);

Regulation (EC) No. 141/2000(9); and

Regulation (EC) No. 847/2000(10)”, and

(iii) for the definition of “relevant medicinal product” there is substituted—

““relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply(11)”;

(b) in regulation 4(6) (applications for the grant, renewal or variation of a United Kingdom marketing authorization), for “point 8(a)(iii) of the second paragraph of Article 4 of the 1965 Directive” there is substituted “point (iii) of sub-paragraph (a) of Article 10.1 of the 2001 Directive”;

(c) in regulation 4(7) (applications for the grant etc. of a United Kingdom marketing authorization), for “point 8(a) of the second paragraph of Article 4 of the 1965 Directive” there is substituted “sub-paragraph (a) of Article 10.1 of the 2001 Directive”;

(d) in regulation 5(4) (consideration, and grant or refusal etc. of an application for a United Kingdom marketing authorization), for “Article 10 of the 1965 Directive” there is substituted “Article 24 of the 2001 Directive”;

(e) in regulation 8(2) (control of retail sale or supply of relevant medicinal products) for “Article 3.4 of Council Directive 92/26/EEC” there is substituted “Article 71.4 of the 2001 Directive”;

(f) in Schedule 1 (exemptions and exceptions from the provisions of regulation 3), in paragraph 2(e) for “Article 16 of Council Directive 75/319/EEC” there is substituted “Article 40 of the 2001 Directive”;

(g) in Schedule 2 (procedural provisions relating to United Kingdom marketing authorizations)—

(i) in paragraph 3 for “Article 13 of Council Directive 75/319/EEC” there is substituted “Article 32 of the 2001 Directive”,

(ii) in paragraph 4(a) for “Article 7.2 of the 1965 Directive” there is substituted “Article 17.2 of the 2001 Directive”, and

(iii) in paragraph 4(b) for “the provisions of Chapter III of Council Directive 75/319/EEC” there is substituted “the provisions of Title III, Chapter 4 of the 2001 Directive”;

(h) in Schedule 3 (offences, penalties etc.)—

(i) in paragraph 6(a) for “Article 4 of the 1965 Directive” there is substituted “Article 8.3 of the 2001 Directive”,

(ii) in paragraph 6(b) and (e) for “Article 9a of the 1965 Directive” there is substituted “Article 23 of the 2001 Directive”,

(iii) in paragraph 6(c) for “paragraph C.a of Part 2 of the Annex to Council Directive 75/318/EEC” there is substituted “paragraph D of Part 2 of Annex I to the 2001 Directive”,

(iv) in each of paragraphs 7, 8, 9 and 10 for “Chapter Va of Council Directive 75/319/EEC” there is substituted “Title IX of the 2001 Directive”, and in paragraph 10 for the words “such Chapter,” there is substituted “such Chapter or Title,”,

(v) in paragraph 10, in sub-paragraph (c) for the words “and promptly,” there is substituted

“and promptly; or

(d) provide to the licensing authority any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on post authorization safety studies,”, and

(vi) in paragraphs 11 and 12 for “Council Directive 92/27/EEC” there is substituted “Title V of the 2001 Directive”, and

(i) in Schedule 5 (labels), in paragraph 2—

(i) for “Council Directive 92/27/EEC” there is substituted “Title V of the 2001 Directive”, and

(ii) for “Council Directive 92/26/EEC” there is substituted “Title VI of the 2001 Directive”.

(1)

S.I. 1994/3144; relevant amendments were made by S.I. 1998/3105, 2000/292, and 2001/795.

(2)

OJ No. L311, 28.11.01, p. 67.

(3)

OJ No. L214, 24.8.93, p. 1.

(4)

OJ No. L55, 11.3.95, p. 5.

(5)

OJ No. L55, 11.3.95, p. 7.

(6)

See Regulation (EC) No. 1146/98 (OJ No. L159, 3.6.98, p. 31).

(7)

OJ No. L55, 11.3.95, p. 15.

(8)

See Regulation (EC) No. 1069/98 (OJ No. L153, 27.5.98, p. 11).

(9)

OJ No. L103, 28.4.00, p. 1.

(10)

OJ No. L18, 22.1.00, p. 5.

(11)

See Articles 2 and 3 of the Directive.