The Medicines (Codification Amendments Etc.) Regulations 2002 (revoked)

Amendment of the Advertising Regulations 1994 U.K.

10.  In the Medicines (Advertising) Regulations 1994 M1 , regulation 2(1) (interpretation) is amended as follows—

(a) after the definition of “common name” 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;”;

(b) in the definition of “essential information compatible with the summary of product characteristics” for “Council Directive 92/28/EEC” there is substituted “ Title VIII of the 2001 Directive ”;

(c) in the definition of “registered homoeopathic medicinal product” for “Council Directive 92/73/EEC” there is substituted “ the 2001 Directive ”;

(d) in the definition of “relevant medicinal product”, in both paragraphs (a) and (b)(i) for “Chapters II to V of the 1965 Directive apply”, in each place where those words occur, there is substituted “ the 2001 Directive applies ”; and

(e) in the definition of “summary of product characteristics” for the words from “article 4a of the 1965 Directive” to “Council Directive 89/341/EEC” inclusive there is substituted “ Article 11 of the 2001 Directive ”.

Marginal Citations

M1 S.I. 1994/1932; relevant amendments were made by S.I. 1994/276 and 3144, and 1999/267.