New EU pharmacovigilance regulations on statute book

Published: 31-Jan-2011

Manufacturers have until July 2012 to conform


New European Union laws on pharmacovigilance have come into force. One is a regulation (which must be followed to the letter) - ec.europa.eu/health/files/eudralex/vol-1/reg_2010_1235/reg_2010_1235_en.pdf - with EU manufacturers having until July 2012 to integrate them in their manufacturing and monitoring systems.

There is also a directive, to be written into member states’ national laws by that date – see ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf.

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