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9. The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(1) are amended as follows—
(a)in regulation 1(2) (interpretation) after the definition of “certificate of registration” 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 regulation 1(3) (interpretation) for “Council Directive 92/73/EEC” there is substituted “the 2001 Directive”;
(c)in regulation 2 (application)—
(i)for “Article 1(4) and (5) of the 1965 Directive” there is substituted “Article 3 of the 2001 Directive”, and
(ii)for “Article 2(4)” there is substituted “Article 5”; and
(d)in regulation 5(1)—
(i)for “Article 7 of Council Directive 92/73/EEC” there is substituted “Article 14 of the 2001 Directive”, and
(ii)for “Article 9” there is substituted “Article 16”.
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