Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004

Having regard to the Treaty establishing the European Community,and in particular Article 95 thereof, Having regard to the proposal by the Commission (1), Having regard to the Opinion of the European Economic and Social Committee (2), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty (3), Whereas:(1) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (4), codified and consolidated in a single text the texts of Community legislation on medicinal products for human use, in the interests of clarity and rationalisation.(2) The Community legislation so far adopted has made a major contribution to the achievement of the objective of the free and safe movement of medicinal products for human use and the elimination of obstacles to trade in such products.However, in the light of the experience acquired, it has become clear that new measures are necessary to eliminate the remaining obstacles to free movement.(3) It is therefore necessary to align the national laws, regulations and administrative provisions which contain differences with regard to the basic principles in order to promote the operation of the internal market while realising a high level of human health protection.(4) The main purpose of any regulation on the manufacture and distribution of medicinal products for human use should be to safeguard public health.However, this objective should be achieved by means which do not hinder the development of the pharmaceutical industry or trade in medicinal products in the Community.(5) Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (5) provided that, within six years of its entry into force, the Commission was required to publish a general report on the experience