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 [...]
The European Medicines Agency (EMA) has invited Marketing Authorisation Holders and other stakeholders to review and provide comments on the draft list of European Union reference dates (referred to as the ‘EURD list’) for periodic safety update reports (PSURs) in preparation for the introduction of the new pharmacovigilance legislation in July [...]
On Tuesday 24 April 2012, the Dutch Medicines Evaluation Board (MEB) will organise a second informative meeting for marketing authorisation holders on the implications of the new pharmacovigilance legislation which enters into force in July 2012. Among the topics discussed will be an update on the transitional arrangements, the Pharmacovigilance System Master File, Article 57(2), [...]
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