New pharmacovigilance legislation comes into force today!

Purple Vigilance joins the EMA in welcoming the start of new European Union legislation on pharmacovigilance. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines. The new pharmacovigilance legislation is comprised of Directive 2010/84/EU and Regulation (EU) No 1235/2010. A key deliverable for the new legislation was the release of a set of Good Pharmacovigilance Practice (GVP) modules.

On 25 June the EMA published the first set of finalised GVP documents that had been released for public consultation earlier this year. The finalised modules released 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.

These documents are a must-read for all Marketing Authorisation Holders – more information and modules can be found using the following link.

Purple Vigilance can help you find your way through the legislation and ensure your systems remain compliant, contact us for more information.