In December 2008 the European Commission proposed the text for a directive to fight against counterfeit medicine. This proposed directive contains a number of provisions which will have a major impact for the GMP environment. In December 2009 the EU Parliament published a Draft Report with the title: "Proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC 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". This document is also called the "Matias" report because the Rapporteur for this document is Marisa Matias from the European Parliament. The new proposal from the EU Parliament contains a number of changes. Some of these are listed below (taken from the summary report):
1) The proposed definition of ''trading of medicinal products'' has been changed to ''brokering of medicinal products'' and amended, thereby clarifying which actors in the supply chain should be subject to the responsibilities of brokers. The proposed introduction of obligations for brokers aim to reinforce the traceability of medicinal products.
2) The proposal includes provisions requiring the accreditation of third-party auditors of Good Manufacturing Practices and Good Distribution Practices. A majority of delegations object to accreditation, since they maintain that such a system could result in a transfer of responsibility from manufacturers and importers as well as make enforcement by national competent authorities more difficult. The Presidency has therefore proposed to delete the provisions regarding accreditation from the text.
3) Other elements of the proposal still need further discussion, notably with regard to the strengthening of controls of non-active substances used in pharmaceuticals (excipients) and the proposed safety features aiming to render falsification more difficult. The current text contains the following amendment: The manufacture of active pharmaceutical ingredients or excipients should be subject to good manufacturing practices irrespective of whether those ingredients or excipients were manufactured in the Community or imported. With regard to their manufacture in third countries, it should be ensured that the rules for the manufacture of active pharmaceutical ingredients or excipients intended for export to the Community, including inspection and enforcement, provide for a level of protection of public health equivalent to that provided for by Community legislation.
It will be interesting to see if this text will be adopted. In this case not only API´s but also excipients will be subject to mandatory inspections. The latest developments with regard to counterfeit regulations will be presented at the Counterfeit Conference of the University of Wuerzburg from 26 - 28 April 2010. Speakers from MHRA (UK), ETCO (Brazil), FDA, WHO and many other organisations will present the current status.
Prepared by:
Oliver Schmidt
On behalf of The European Compliance Academy (ECA )
