The Medicines (Labelling and Leaflets) Amendment Regulations 1994
These Regulations further amend the Medicines (Labelling) Regulations 1976 (“the Labelling Regulations”) and the Medicines (Leaflets) Regulations 1977 (“the Leaflets Regulations”) by implementing in part Council Directive 92/73/EEC (OJ No. L297, 13.10.1992, p. 8) (“the Directive”) which widens the scope of Directives 65/65/EEC (OJ No.22, 9.2.1965, p. 369/65) and 75/319/EEC (OJ No. L147, 9.6.1975, p. 13) on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down additional provisions on homoeopathic medicinal products.