On 11 March 2008 the EU Commission issued a proposal for drafting a legislative initiative for combating medicine counterfeits - see also GMP News from 9 April 2008.

The proposal also comprised a more comprehensive control of the so-called supply chain for finished products as well as for APIs. In addition, it is planned to conduct GMP inspections at API manufacturers in Europe and outside the EU boarders.

The now published comments from the various groups showed how important the issue is for both authorities and industry. Altogether 100 stakeholders sent their comments, among them associations, individual pharmaceutical manufacturers, retailers and also patient groups.

The comments demonstrate the different groups' interests and how difficult it will be for the EU Commission to consider all of them. Medicinal product safety is not always the centre of attention. However, most organisations basically welcome the EU Commission's initiative. But there's also frequent criticism, that already existing programmes such as the WHO IMPACT Programme and the FDA Initiatives have to be better coordinated to really find a solution to the problem of counterfeits.

Especially labelling systems (so-called trace and track processes) generated comprehensive comments. The European Federation of Pharmaceutical Industries and Associations (EFPIA) emphasises in its comment that harmonisation is absolutely necessary, because several countries already established labelling systems. However, these systems are neither synchronised nor compatible.

Author:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

Source: http://ec.europa.eu/enterprise/pharmaceuticals/counterf_par_trade/counterfeit_consult_2008.htm