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52008SC2671

Title and reference

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}

/* SEC/2008/2671 final */

Text

Dates

Classifications

EUROVOC descriptor:
medicament
drug surveillance
marketing
European Medicines Agency
Directory code:
13.30.15.00 Industrial policy and internal market / Internal market: approximation of laws / Proprietary medicinal products
Subject matter:
Approximation of laws, Internal market, Technical barriers, public health, Industry

Miscellaneous information

Author:
European Commission
Form:
Summary of the impact assessment

Relationship between documents

Treaty:
European Community
Subsequent related instruments:
Relation 52008PC0664
Relation 52008PC0665
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