İyi farmakovijilans uygulamaları kılavuzu: Modül VI – Advers reaksiyonların yönetimi ve raporlanması (İng)



Guideline on good pharmacovigilance practices (GVP): Module VI – Management and reporting of adverse reactions to medicinal products

This Module addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and Chapter 3 of Regulation (EC) No 726/2004 [REG], which are applicable to competent authorities in Member States, marketing authorisation holders and the Agency as regards the collection, data management and reporting of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union (EU).