New Pharmacovigilance Legislation 2012

Reporting of domestic non-serious reports

erol — Mon, 07 May 2012 11:39:11 +0000

We understand that Marketing Authorisation Holders (MAHs) need to have clear instructions on the submission of domestic non-serious cases as from July 2012, as procedures and IT-related changes can’t be made over night.

The submission of domestic non-serious cases is still under discussion within the EU regulatory network. The Medicines Evaluation Board (MEB) will await [...]

Informative meeting new pharmacovigilance legislation on 24 April 2012

erol — Fri, 27 Apr 2012 09:40:15 +0000

On 24 april 2012 the Medicines Evaluation Board (MEB) organised another informative meeting in Utrecht about the implications of the new pharmacovigilance legislation. This meeting with 200 participants was primarily targeted at marketing authorisation holders.

The new legislation enters into force on 1 July 2012 and also has implications for pharmaceutical companies. During the [...]

Wijziging Geneesmiddelenwet ter implementatie van Richtlijn 2010/84/EU

erol — Fri, 13 Apr 2012 08:43:41 +0000

Het Europees Parlement en de Raad van de Europese Unie hebben eind december 2010 de herziene wetgeving t.a.v. farmacovigilantie aangenomen, waarna de lidstaten 18 maanden de tijd hadden om de wetgeving nationaal te implementeren. In Nederland treft het Ministerie van VWS maatregelen om de wijzigingen te verwerken in de nationale Geneesmiddelenwet. Het concept wetsvoorstel wijziging Geneesmiddelenwet [...]