欧盟药物警戒指南European Medicines Agency - Pharmacovigilance - Good pharmacovigilance practices.pdfVIP

16- 1-26 European Medicines Agency - Pharmacovig ilance - Good pharmacovig ilance practices European Medicines Agency - Science, medicines, health Good pharmacovigilance practices Good pharmacov igilance pract ices (GV P) are a set of measures drawn up to facilitate t he performance of pharmacov igilance in t he European Union (EU). GV P apply to market ing- aut horisat ion holders, t he European Medicines A gency and medicines regulatory aut horit ies in EU Member States. They cover medicines aut horised cent rally v ia t he A gency as well as medicines aut horised at nat ional level. Guideline on GVP The guideline on GV P is divided into chapters that fall into two categories: modules covering major pharmacovigilance processes; product- or population-specific considerations. Each chapter is developed by a team consisting of experts from the European Medicines Agency and from EU Member States. The guideline on GVP is a key deliverable of the 2010 pharmacovigilance legislation. Modules covering major pharmacovigilance processes GV P modules I to XVI cover major pharmacovigilance processes and the development of this set of guidance is concluded. The module numbers XI, XII, XIII and XIV stay void, as their planned topics have been addressed by other guidance documents on the Agency’s website (see Related links box below Final GVP modules table). Product- or population-specific considerations The chapters on product- or populat ion-specific considerat ions have been developed for vaccines and biological medicinal products. Two more considerations chapters are planned as follows: Date of release for public Chapter number Chapter t it le consultat ion P III