DG SANCO initiates a public consultation on the fees for pharmacovigilance to be charged by the European Medicines Agency (EMA). The new pharmacovigilance Regulation 1235/2010 and Directive 2010/84 start applying in July 2012. This legislation should substantially strengthen the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of EMA, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns. It also enables EMA to charge fees for its new pharmacovigilance activities. With this public consultation, DG SANCO intends to consult all stakeholders on the proposed structure and levels of fees for pharmacovigilance. The public consultation paper can be found here.
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