Pharmacovigilance EU Documents


EU Commission


1. Directive 2001/83 EC - HERE


2. Regulation (EC) No 726/2004 (the legal framework of pharmacovigilance for medicines marketed within the EU with respect to centrally authorised medicinal products) - HERE


3. Commission Implementing Regulation (EU) No 520/2012 (on the performance of pharmacovigilance activities stipulates operational details in relation to certain aspects of pharmacovigilance to be respected by marketing authorisation holders, national competent authorities and EMA) - HERE


4.Regulation 1235/2010 (Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products Text with EEA relevance (Consolidated version : 01/01/2011) - HERE


5.Directive 2010/84/EC (Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. (Official Journal L 348, 31/12/2010, p.†74 - 99) - HERE


EMA Documents:


1. Guideline on good pharmacovigilance practices (GVP) - HERE


2. Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems - HERE


3. Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file (Rev 1)- HERE


4.Guideline on good pharmacovigilance practices (GVP) Module III - Pharmacovigilance inspections (Rev 1) - HERE


5. Guideline on good pharmacovigilance practices (GVP) Module IV – Pharmacovigilance audits (Rev1) - HERE


6. Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 1) - HERE


7. Guideline on good pharmacovigilance practices (GVP) Module VI - Management and reporting of adverse reactions to medicinal products (Rev 1) - HERE


8. Guideline on good pharmacovigilance practices (GVP) Module VII– Periodic safety update report(Rev1) - HERE


9. Guideline on good pharmacovigilance practices (GVP) Module VIII - Post-authorisation safety studies (Rev2) - HERE


10. Guideline on good pharmacovigilance practices (GVP) Module IX - Signal management - HERE


11. Guideline on good pharmacovigilance practices (GVP) Module X - Additional monitoring - HERE


12. EURD List: HERE


13. PRAC: Agendas, minutes and highlights (lists the meeting highlights, agendas and minutes from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) plenary meetings) - HERE


14. Outcomes of periodic safety update report single assessments - HERE


15. Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to MAH during the interim period - HERE


16. Note for guidance – EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs) - HERE


17. e-transmission of ICSRs to the EMA: Steps to follow in case of system failure - HERE


18. Monitoring of medical literature and entry of adverse reaction reports into EudraVigilance - HERE


19. Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the EMA - HERE


20. Detailed guide regarding the monitoring of medical literature and the entry of relevant information in to the EudraVigilance database by the EMA - HERE


21. Periodic safety update reports: questions and answers - HERE


22. - List of medicines under additional monitoring - HERE


CMDh Documents


1. Requirements on Submissions for Periodic safety update reports (PSUR) to National Competent Authorities (NCAs) products authorised via National Procedures, MRP and DCP (NAPs) - HERE