PART 5 U.K.Marketing authorisations

Revocation, variation and suspension of marketing authorisation U.K.

Authorisations granted under Chapter 4 of Title III of the 2001 Directive U.K.

70.—(1) Regulations 68 and 69 do not apply in relation to a UK marketing authorisation that—

(a) was granted in accordance with the provisions of Chapter 4 of Title III of the 2001 Directive (mutual recognition procedure and decentralised procedure);

(b) was granted before 1st January 1995 in accordance with Article 4 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology M1 ; or

(c) was subject to the procedure laid down in Articles 32 to 34 of the 2001 Directive following a referral under Article 30 or 31 of that Directive, unless the procedure was limited to certain specific parts of the authorisation.

(2) A proposal by the licensing authority to vary, suspend or revoke a marketing authorisation within paragraph (1), or an application by the holder of such an authorisation to vary or revoke it, is to be determined in accordance with Chapter 4 of Title III of the 2001 Directive.

Marginal Citations

M1 OJ No L 15, 17.1.1987. p.38.