The new EU Pharmacovigilance legislation involves a substantial overhaul of the current system. Implementing it by the July 2012 deadline was always going to be a challenge. Aginus Kalis, executive director of the MEB and chair of the management group of the EU Heads of Medicines Agencies, confirmed just how big that challenge is.
This [...]
In anticipation of the new pharmacovigilance legislation the Medicines Evaluation Board (MEB) decided to simplify the electronic handling of suspected adverse drug reaction reports requiring expedited reporting according to Regulation (EC) No 726/2004 and Directive 2001/83/EC as amended. Marketing Authorisation Holders (MAHs) no longer need to send these reports to the MEB, but should instead [...]
As one of the first implementing steps, the European Medicines Agency has published the format in which, by 2 July 2012, marketing authorisation holders shall submit information on all medicines for human use authorised or registered in the European Union as provided for in Article 57(2) of the Regulation. Read more about the
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