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 [...]
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 published a new implementation plan detailing the activities around the new pharmacovigilance legislation scheduled for implementation in 2012 and those activities which will be the focus beyond 2012. Activities contributing to public health are given the highest priority, followed by activities to increase transparency and improve communication, and then [...]
The European Commission has published a Q&A document on transitional arrangements for the new pharmacovigilance legislation in preparation for the coming into force of the legislation in July 2012. Of particular interest to marketing-authorisation applicants and holders, the document provides answers to both legal and practical [...]
The European Medicines Agency (EMA) has released the first batch of modules on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012.
The GVP modules will replace Volume 9A and will set out detailed, practical guidance on how Marketing Authorisation Holders, [...]
The presentations of the 4th Stakeholder meeting hosted by the European Medicines Agency (EMA) on 27 February 2012 are now available.
The objectives of this fourth meeting were to present an update on the implementation process, transitional arrangements and discuss the
Article 57(2) of Regulation (EC) No 1235/2010 requires marketing authorisation holders (MAHs) to electronically submit information on all medicinal products for human use authorised in the EU by 2 July 2012. The European Medicines Agency (EMA) has today published an
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), [...]
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 [...]
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 [...]
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