The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000

Amendment of regulation 1(2) of the principal Regulations

2.  In the definition of “the relevant Community provisions” in regulation 1(2) of the principal Regulations (interpretation)—

(a) in the list of Community provisions, at the end of the entry “Council Directive 75/318/EEC(1)” there shall be added “as last amended by Commission Directive 1999/83/EC(2)”; and

(b) for the words from “as they have” to “into force” there shall be substituted the words “but the amendments to the Annex of Council Directive 75/318/EEC in Commission Directive 1999/82/EC(3) shall only apply as respects new applications for marketing authorizations from 1st July 2000 and as respects all marketing authorizations from 1st March 2001”.

(1)

OJ No. L 147, 9.6.1975, p. 1. This Directive has been amended by Council Directive 95/319/EEC (OJ No. L 147, 9.6.1975, p. 13), Council Directive 83/570/EEC (OJ No. L332, 28.11.1983, p. 1), Council Directive 87/19/EEC (OJ No. L 15, 17.1.1987, p. 31), Council Directive 89/341/EEC (OJ No. L 142, 25.5.1989, p. 11) Commission Directive 91/507/EEC (OJ No. L270, 26.9.1991, p. 32), Council Directive 93/39/EEC (OJ No. L214, 24.8.93, p. 22), Commission Directive 1999/82/EC (OJ No. L 243, 15.9.1999, p. 7) and Commission Directive 1999/83/EC (OJ No. L243, 15.9.1999, p. 7).

(2)

For the OJ reference for this Directive and the other Directives amending Council Directive 75/318/EEC, see the previous footnote entry.

(3)

ibid.