İyi farmakovijilans uygulamaları kılavuzunun 2 yeni modülü daha yayımlandı.


Two modules of guideline on good pharmacovigilance practices released for public consultation


The European Medicines Agency has released two further modules of the guideline on good pharmacovigilance practices (GVP) for public consultation until 24 August 2012. The modules are:

  • Module III: Pharmacovigilance inspections;
  • Module X: Additional monitoring.

GVP is a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). They apply to marketing-authorisation holders, the Agency and medicines regulatory authorities in EU Member States and aim to improve safety for patients by strengthening the monitoring of the safety of medicines across the EU. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

The two modules released today are the first in the second batch of modules to be released for public consultation. The remaining seven draft modules making up the entire GVP package are under development and will be released for consultation later in the year.

Each of the full set of 16 modules covers one major process in the safety monitoring of medicines and is developed by a team consisting of experts from the Agency and from EU Member States. They are a key deliverable of the 2010 pharmacovigilance legislation, which will begin to apply from Monday 2 July 2012.

The first batch of seven modules, which covered the core processes that need to be running when the new legislation starts to apply, were open for comments between February and April this year. These seven modules were finalised and published earlier this week.

The Agency is seeking comments on the practical implementation of the legislation as outlined in the two modules published today. The underlying legal requirements cannot be altered through this consultation process.