MHRA Questions European Commission Proposals

While the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) supports the European Commission’s (EC) proposal to combat drug counterfeiting, it says certain requirements conflict with UK regulations.

The most troublesome part of the EC proposal is a ban on repackaging and a requirement that the outer packaging of certain drugs bear a unique manufacturer’s seal that would accompany it all the way to the retailer or wholesaler, the MHRA says. The drugs subject to this requirement would be determined through a risk-based approach.

While acknowledging that drug packs opened within the supply chain are vulnerable to counterfeiting, MHRA Director of Policy Shaun Gallagher said requiring them to remain sealed would prevent importers from elsewhere in the European Union from complying with UK regulations requiring products to have an English-language leaflet and labeling of the primary and secondary containers.

Under the EC’s proposal, the right to open the outer packaging would be restricted to the market authorization holders and end users, such as hospitals, healthcare professionals and patients. “It will be important to ensure that the definition of end-user does not adversely impact on legitimate practitioners and acceptable practices within the member states,” Gallagher said.

The MHRA also wants to know who would determine which drugs are subject to the repackaging requirement. It wants an exemption for all drugs undergoing clinical trials.

The EC recently released its public consultation on legislative proposals designed to combat counterfeit drugs. One proposal is to allow member states to conduct both announced and unannounced audits of active pharmaceutical ingredient production facilities.

The EC proposal can be viewed at ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2008/2008_03/consult_counterfeit_20080307.pdf, and the MHRA comments are posted at www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON015430&RevisionSelectionMethod=LatestReleased.