European Commission 21 October 2008, Commission staff working document - Accompanying document to the :#Proposal for a Regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency and the : #Proposal for a Directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use #Summary of the impact assessment {COM(2008) 664 final} {COM(2008) 665 final} {SEC(2008) 2670}

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