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10. In the Medicines (Advertising) Regulations 1994(1), 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”.
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