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[Major milestones for European pharmaceutical policy].

Authors :
Sauer F
Source :
Revue d'histoire de la pharmacie [Rev Hist Pharm (Paris)] 2014 Jan; Vol. 62 (381), pp. 61-74.
Publication Year :
2014

Abstract

Under the 1985 White Paper on the completion of the single market, several pharmaceutical harmonisation measures were unanimously adopted, in favor of biotech products and on pricing transparency, legal status of prescription, wholesale distribution and advertising. The European pharmaceutical harmonisation was extended to Norway and Iceland, to new accession member states and through major international conferences with the US and Japan (ICH). Starting in 1995, the European medicines agency has produced an efficient marketing authorisation system for new human and veterinary medicines. The system was extended to pediatric medicines and advanced therapies. The monitoring of drug adverse effects (pharmacovigilance) has been gradually strengthened.

Details

Language :
French
ISSN :
0035-2349
Volume :
62
Issue :
381
Database :
MEDLINE
Journal :
Revue d'histoire de la pharmacie
Publication Type :
Academic Journal
Accession number :
25668913