On December 10, 2008, the European Commission published a series of political measures and legislative proposals, the so-called "Pharmaceutical Package." This series included the "Communication on a renewed vision for the pharmaceutical sector," which reflected on ways to improve market access and develop initiatives to boost European Union ("EU") pharmaceutical research. Through the Pharmaceutical Package, the European Commission aims to make pricing and reimbursement more transparent, increase the development of pharmaceutical research within the EU, improve the safety of medicines worldwide, and reinforce cooperation with international partners.
The European Commission has published three separate sets of proposals amending Directive 2001/83/EC on the Community Code of medicinal products and Regulation 726/2004 on medicinal products obtained through centralized procedures:
1. A proposal amending Directive 2001/83 as "regards information to the general public on medicinal products subject to medical prescription" (Information to patient);
2. A proposal amending Directive 2001/83 and a proposal amending Regulation 726/2004 as "regards pharmacovigilance" (The EU pharmacovigilance system); and,
3. A proposal amending Directive 2001/83 as "regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source" (Counterfeit Medicines).… Continue Reading
At EU level, there are essentially two routes to obtaining an authorization from the EMEA to place a product on the market more quickly than through the usual marketing authorization route. The first is an application for a conditional authorization that is available where clinical trials have not been fully completed. This is not a … Continue Reading