DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 6 November 2001on the Community code relating to medicinal products for human useTHE EUROPEAN PARLIAMENT AND THE COUNCIL OFTHE EUROPEAN UNION,HavingregardtotheTreatyestablishingtheEuropeanCommunity, and in particular Article 95 thereof,Having regard to the proposal from the Commission;Having regard to the opinion of the Economic and SocialCommittee (1),Acting in accordance with the procedure laid down in Article251 of the Treaty (2),Whereas:(1)Council Directive 65/65/EEC of 26 January 1965 on theapproximationofprovisionslaiddownbylaw,regulation or administrative action relating to medicinalproducts (3), Council Directive 75/318/EEC of 20 May1975 on the approximation of the laws of MemberStates relating to analytical, pharmaco-toxicological andclinical standards and protocols in respect of the testingof proprietary medicinal products (4), Council Directive75/319/EEC of 20 May 1975 on the approximation ofprovisionslaiddownbylaw,regulationoradministrative action relating to proprietary medicinalproducts (5), Council Directive 89/342/EEC of 3 May1989 extending the scope of Directives 65/65/EEC and75/319/EEC and laying down additional provisions forimmunologicalmedicinalproductsconsistingofvaccines, toxins or serums and allergens (6), CouncilDirective 89/343/EEC of 3 May 1989 extending thescope of Directives 65/65/EEC and 75/319/EEC andlayingdownadditionalprovisionsforradiopharmaceuticals (7), Council Directive 89/381/EECof 14 June 1989 extending the scope of Directives65/65/EEC and 75/319/EEC on the approximation ofprovisionslaiddownbylaw,regulationoradministrative action relating to medicinal products andlaying down special provisions for proprietary medicinalproductsderivedfromhumanbloodorhumanplasma (8...
