Recently, the European Commission presented new draft Guidelines on Pharmacovigilance for Medicinal Products for Human Use in the EU (Volume 9A)1. These revised Guidelines, if adopted, will be of great importance to how drug safety is conducted in the EU. Stakeholder comments are due by March 17, 2006.
The draft Volume 9A contains substantial amendments compared to the Commission’s current Guidelines on Pharmacovigilance (Volume 9). The suggested amendments reflect recent comprehensive changes to EU pharmacovigilance legislation2 as well as international harmonization, and scientific and technical progress. The draft Volume 9A differs from Volume 9 in that it only concerns medicinal products for human use and not also veterinary medicinal products. The new draft guidelines also contain rules in a number of areas that are not covered by the current Guidelines, such as on requirements for risk management systems.
Other important changes include:
- New and more detailed rules on the role and responsibilities of the Qualfied Person Responsible for Pharmacovigilance;
- Altered guidance on pharmacovigilance obligations in contractual arrangements;
- New provisions relating to information on adverse reactions available on the Internet;
- Changes to the reporting timelines for periodic safety update reports in line with recent legislative changes.
Finally, differences in terms of form include a new structure and more detailed introductions to the various parts.
Click here to access the draft Volume 9A.
http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/12-05/draft%20of%20Volume%209a_12_2005.pdf
Click here to access the Commission’s note on the public consultation on Volume 9A.
Click here to access the form for submission of comments on Volume 9A.
1 Draft Volume 9A of the Rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance for Medicinal Products for Human Use.
2 Regulation EC No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, which entered into force on 20 November 2005 and Directive 2001/83/EC on the Community code relating to medicinal products for human use, as amended, which should have been introduced by all EU Member States from 30 October 2005.
This article has been prepared by Sidley Austin Brown & Wood LLP for informational purposes only and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Readers should not act upon this without seeking professional counsel.