The European Commission, the European Parliament and the Council of the Member States’ Health Ministers are all involved in developing the European legislation on patient information.
Since 2012, the legislative process has been blocked by the Council, which refuses to consider the European Commission's proposals, even with modifications.
The European Commission's initial proposals
- Proposed Directive by the European Parliament and the Council, amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use (December 2008) > Pdf, 114 Ko
- Proposed Regulation by the European Parliament and the Council, amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 (December 2008) > Pdf, 95 Ko
For information on the key steps of the process
Information on the key stages (first and second readings, etc) and for all the key documents (the Commission's proposals, reports by the European Parliament, etc) is available on the European Parliament's internet site:
©Prescrire November 2014