5. The Medicines (Labelling) Regulations 1976 M1 are amended as follows—
(a)in regulation 3(1) (interpretation)—
(i)after the definition of “data sheet” 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;”,
(ii)for the definition of “homoeopathic product to which Council Directive 92/73/EEC applies” there is substituted—
““homoeopathic product to which the 2001 Directive applies” means a medicinal product for human use (which may contain a number of principles) prepared from products, substances or compositions called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State, other than one—
(i)prepared in accordance with a magistral or officinal formula as described in Article 3(1) and (2) of the 2001 Directive, or
(ii)which satisfies the criteria laid down in Article 5 of the 2001 Directive;”,
(iii) the definition of “product to which Chapters II to V of the 1965 Directive applies” is deleted, and
(iv) in the definition of “relevant medicinal product” for “Chapters II to V of the 1965 Directive” there is substituted “ the 2001 Directive ”;
(b)in regulation 4A (standard labelling requirement), in paragraph (5)—
(i)for the words from “Article 4a of Directive 65/65/EEC” to “Directive 89/341/EEC” inclusive there is substituted “ Article 11.1 to 11.7 of the 2001 Directive ”, and
(ii)in sub-paragraph (b), for “Article 4a of Directive 65/65/EEC” there is substituted “ Article 11.1 to 11.7 of the 2001 Directive ”;
(c)in regulation 4B (standard labelling requirements for radiopharmaceuticals) for “Chapters II to V of the 1965 Directive” there is substituted “ the 2001 Directive ”; and
(d)in regulation 4F (standard labelling requirements for certain homoeopathic products), in paragraph (1) for “Council Directive 92/73/EEC” there is substituted “ the 2001 Directive ”.
Marginal Citations
M1S.I. 1976/1726; relevant amendments were made by S.I. 1992/3273, 1994/104 and 3144 and 1996/2194.