Friday, 6 February 2015

New Pharmacovigilance Legislation

The new EU 15 modules concerning pharmacovigilance are a major departure in terms of the pharmacovigilance conducted over the last 6 years in Europe since the introduction of Vol IXa. New pharmacovigilance legislation changes apply from April 2015..

The requirements for information provided to Competent Authorities and the European Medicines Agency (EMA) about the pharmacovigilance system(s) of marketing authorisation holders (MAHs) change in several ways: 
  • Summary information only concerning the EU qualified person for pharmacovigilance (QPPV) and the location of a pharmacovigilance system master file will be contained in marketing authorisations.
  • Full descriptive information about the pharmacovigilance system will have to be contained in a pharmacovigilance system master file, which should be made available to the National Competent Authorities upon request.
  • Detailed requirements for the pharmacovigilance system master file concern its availability, structure, content and maintenance.
  • The pharmacovigilance system master file will encompass the pharmacovigilance system and may therefore relate to one or more products, and changes to its content will not be automatically notifiable to the Competent Authorities. This differs from the current Detailed Description of the Pharmacovigilance system (DDPS), which will be phased out over the period from July 2012 to 2015.


 Posted by Tim Sandle