Amendment of the Labelling Regulations 19765
The Medicines (Labelling) Regulations 19767 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”.