22/23 February 2024
The European Medicines Agency (EMA) has published drafts of the following revised and new modules and documents of the Guideline on good pharmacovigilance practices (GVP):
Comments on those drafts should be sent to EMA until 29 February 2016. You can find the drafts on the Eudralex Volume 9 GVP website under "Draft GVP chapters and annexes for public consultation".
The chapters on product- or population-specific considerations have now been developed for vaccines and biological medicinal products. Two more consideration chapters are planned: P III Pregnancy and breast-feeding and P IV Geriatric population. These chapters are expected to be released for public consultation in the second quarter of 2016.
The EMA further released an Addendum I "Educational materials" with regard to GVP module XVI "Risk minimisation measures - Selection of tools and effectiveness indicators". The document has been in force since 16 December 2015. It describes the requirements on the creation, submission, distribution and supply of educational materials. For the safe use of some medicinal products additional information might be required. This supplementary information has to be provided in form of "educational material" in addition to SmPC (Summary of Product Characteristics) and package leaflet.
EMA Newsletter "Pharmacovigilance programme update - Issue 6 available:
In July 2014, the EMA has also started a Newsletter focussing on pharmacovigilance ("News bulletin for pharmacovigilance programme update"). With this quaterly issued Newsletter, EMA keeps informed all marketing authorisation holders (MAHs) of the latest developments in the field of pharmacovigilance. Now, the sixth Newsletter is available. Among other things, it contains news and timetables on the following topics:
Qualified Persons for Pharmacovigilance (QPPVs) who are registered in the XEVMPD database according to Article 57 of Regulation (EG) No 726/2004 receive this document directly via EudraLink. You can find the Newsletter on the website of the EMA.