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
M1OJ No L 15, 17.1.1987. p.38.