Farmakovijilans alanındaki yeni düzenlemeler Temmuz 2012’den itibaren Avrupa Birliği’nde uygulamaya konacak.
2012 Haziran’da AB’de yürürlüğe girecek olan İyi Farmakovijilans Uygulamaları için kılavuzlar hazırlayan EMA, ilk 7 modülü, değerlendirilmek üzere kamuoyuna sundu.
EMA (EUROPEAN MEDICINES AGENCY)
Guidelines on good pharmacovigilance practices (GVP)
Introductory cover note to the public consultation of the first seven modules
Background to public consultation on GVP
New legislation for pharmacovigilance will apply in the European Union (EU) as of July 2012, and to support its implementation a new set of guidelines for the conduct of pharmacovigilance in the EU is under development which, as they are adopted, will replace the current set in Volume 9A of the Rules Governing Medicinal Products in the EU.
This new guidance on good pharmacovigilance practices (GVP) is organised into Modules, and the first seven Modules on prioritised topics are now available for public consultation.
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