Regulation 2 Amendment of regulation 2 of the principal Regulations

In paragraph (1) of regulation 2 of the principal Regulations (interpretation), after the definition of “parenteral administration” there shall be inserted the following—

• ““product to which Chapters II to V of the 1965 Directive apply” means a medicinal product to which, in accordance with Article 2 of Council Directive 65/65/EEC as amended^f1, Article 34 of Council Directive 75/319/EEC^f2, Article 1 of Council Directive 89/342/EEC^f3, Article 1 of Council Directive 89/343/EEC^f4 and Article 1 of Council Directive 89/381/EEC^f5, Chapters II to V of Council Directive 65/65/EEC apply;”.