EMA Releases GVP Modules for Public Consultation

The European Medicines Agency have today released seven of the long awaited good pharmacovigilance practice (GVP) modules for consultation. The modules outline the practical implementation of the new PV legislation that will apply from July 2012, and will make essential reading for all Marketing Authorisation Holders and other interested parties. The remaining nine modules are being developed and will be released later in 2012.

The GVP modules released today are as follows:

  • Module I: Pharmacovigilance systems and their quality systems;
  • Module II: Pharmacovigilance systems master files;
  • Module V: Risk management systems;
  • Module VI: Management and reporting of adverse reactions to medicinal products;
  • Module VII: Periodic safety update reports;
  • Module VIII: Post-authorisation safety studies;
  • Module IX: Signal management.

The consultation closes on 18th April 2012 and the EMA hope to finalise these modules for publication by July 2012.

More information and the draft modules can be found at the following link:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001451.jsp&mid=WC0b01ac058004d5c1

MHRA open public consultation on transposition of Pharmacovigilance Directive 2010/84/EU into UK Law

The MHRA is inviting comments on the transposition of the Pharmacovigilance Directive 2010/84/EU into UK law.  The new PV legislation comes into force in July 2012 and the documents provided by the MHRA give an insight into the proposals for UK.

Comments should be provided to the MHRA by 28th February 2012.

More information can be found by the following the link below:

http://www.mhra.gov.uk/Publications/Consultations/Medicinesconsultations/MLXs/CON137667

 

Public Consultation on Implementing Measures of New PV Legislation

The European Commission is seeking the views of stakeholders on the implementing measures for the performance of the new activities that were introduced by the amended Pharmacovigilance legislation.

The public consultation on these measures is open to all – do not miss the opportunity to have your say and gain further insight into the new Pharmacovigilance legislation that comes into force in July 2012.

The concept paper and more information on how to provide your feedback can be found by following the link below.  The deadline for comments is 7th November 2011.

http://ec.europa.eu/health/human-use/pharmacovigilance/developments/index_en.htm