Portal de Periódicos da CAPES

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001

2009; IOS Press; Volume: 11; Issue: 4 Linguagem: Inglês

10.3233/ppl-2009-0234

2210-495X

EU Law and Policy Analysis

Having regard to the Treaty establishing the European Community,and in particular Article 95 thereof, Having regard to the proposal from the Commission; Having regard to the opinion of the Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (2), Whereas: (1) Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (3), Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (4), Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (5), Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens (6), Council Directive 89/343/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for radiopharmaceuticals (7), Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down special provisions for proprietary medicinal products derived from human blood or human plasma (8), Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use (9), Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use (10), Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets (11), Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use (12), Council Directive 92/73/EEC of 22 September