Pharmacovigilance: new european legislation

The European Parlament adopped on the 22/09/2010 new legislation regarding pharmacovigilance in the European Union.

The new pharmacovigilance legislation:

  • Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010: Amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use;
  • Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010: Amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products.

Several changes will be implemented:

  • Reinforcement of the Post-Marketing Authorization monitoring of risks and benefits of medicinal products : Certain medicinal products, for instance those including a new substance, will be authorised only if additional tests are done. These medicinal products will be identified by a black symbol on their leaflet.
  • Eudravigilance data base will become the only reception point of pharmacovigilance information from marketing authorization holders and national competent authorities.
  • The Pharmacovigilance Working Party will be replaced by a Committee which will function at EMA (European Medicines Agency).
  • More transparency for safety information:
    • Medicinal product data bases will be created at national and European level;
    • Patients will be able to notify undesirable effects directly to national authorities;
    • A public European portal (with links to national agencies) will be created, compiling information about medicinal products (evaluation reports, Summary of Product Characteristics, leaflets).

The new legislation will come into force until mid-2012.

Source: European parliament press release.