On 27 May 2011 the EU Council has formally adopted the Falsified Medicines Directive. Its publication in the Official Journal of the European Union is about to happen within the next days. This new Directive contains substantial changes in the provisions with respect to GMP/GDP for APIs and Excipients and will have comprehensive consequences for the industry dealing with these materials.
On the 4th European GMP Conference which was held in Heidelberg some weeks ago a presentation was provided by Julie Maréchal-Jamil from the Brussels based European Generic medicines Association (EGA). The presentation informed among others about the key issues in this new Directive with regard to APIs and Excipients. Open questions related to the implementation of the upcoming new GMP/GDP requirements for APIs and Excipients were highlighted and the following main concerns were discussed intensively:
- The registration should be formalised by means of an EU template registration form and the handling of changes/change notification should be harmonised.
- The notification procedure has to be adapted to EU multi-site operators in order to avoid duplication.
- A public repository of inspection outcomes is needed.
- The guidelines on the formalised risk assessment yet to be established and adopted by the Commission should fairly reflect today’s best practices in performing risk assessments. It should further focus on principles and be cost-effective.
The Falsified Medicines Directive was adopted by the European Parliament on 16 February 2011 and by the EU Council on 27 May 2001. After publication in the Official Journal of the European Union the EU member states are required to transpose the Directive into national law within a 18 months period. For sure this Directive will be a major challenge for both the API industry of many non-EU countries and most of the excipients manufacturers as well as for agents, brokers, traders and of course for the pharmaceutical industry. It will be of key importance to be prepared to the new situation.
Please also see the EU Council's press release.
To find out more please see the currently applicable directive 2001/83/EC, the final draft of the directive as well as the latest modifications in the Directive from 12 April 2011. This will also be the version expected to be published in the Official Journal of the EU (after formal approval in the European Council). Please find here the explanatory note for this latest corrigendum.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Sr Manager Quality & Regulatory Affairs
EUROPEAN GENERIC MEDICINES ASSOCIATION