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
M1S.I. 1994/1932; relevant amendments were made by S.I. 1994/276 and 3144, and 1999/267.