Regulatory Roundup: European Parliament Approves Proposals On Falsified Medicines and Pharmacovigilance; And More.

ePT--the Electronic Newsletter of Pharmaceutical Technology

European Parliament Approves Proposals On Falsified Medicines and Pharmacovigilance; And More.

Regulatory Roundup

Pharmaceutical Technology reported on the USP Convention in last week’s ePT. More information is now available on the USP website, including a list of all nine adopted resolutions. Some of the topics included grandfathering constitutionally named organizations, expanding harmonization efforts as well as collaboration efforts with US Food and Drug Administration, and exploring the development of quality standards of value to practitioners and the public.


The proposals on falsified medicines and pharmacovigilance, part of a three-part codecision package proposed by the European Commission in December 2008, were approved by the Environment, Public Health, and Food Safety Committee of the European Parliament on Apr. 27, 2010. The third part, on patient information on prescription medicines, is likely to be debated by the committee in June 2010, according to a press release by the European Parliament. Under the proposal approved by the committee, Internet sites that sell pharmaceuticals in European Union member states would have to obtain special authorization. These sites would be required to bear an EU logo to help the public confirm that the site is linked to an authorized pharmacy. All authorized Internet pharmacies would be linked to a central website at a member-state level and listed in an European database. Citizens also would be informed about the risks involved in buying medicinal products on the Internet.

The European Parliament's Environment Committee also introduced measures to require mandatory safety features, such as seals or serial numbers, for certain medicines. These features would be required for prescription medicines, but the requirement could be waived (e.g., for generic medicines) following an assessment by the European Commission. The committee also wants the European Commission to assess, after four years, whether this requirement should be extended to nonprescription medicines. The measure is intended to counter the growing number of medicinal products that are "falsified in relation to their identity, history or source," according to the press release. In December 2008, the European Commission customs officials seized more than 34 million illegal pills across the EU.