The EU and Cambodia have recently taken additional steps in the fight against counterfeit drugs: the Council of Europe (EC) updated the EU draft guidance on “falsified medicines,” and Cambodia initiated a crackdown on illegal pharmacies operating in their country.
In late April, the EC published a set of draft amendments to EU Directive 2001/83/EC aimed at preventing “the entry into the legal supply chain of medicinal products which are falsified.” The draft defines a medicine as “falsified” if any aspect of its composition, manufacture, origin, or history is misrepresented, including records relating to its distribution.
Falsified active pharmaceutical ingredients (APIs) are also addressed, with a recommendation that competent authorities need to inspect both manufacturers and distributors of APIs used as starting materials.
The EC draft explains that safety features are still under debate. Discussions among committee members regarding what types of products should be subject to safety features indicate that “most delegations” are in favor of creating provisions that allow that certain nonprescription drugs at high risk of being counterfeited could be subject to compulsory safety features, the document reports. It also notes that a “large number” of delegations believe that it should be possible to exclude certain categories of prescription-only medicines at low risk of falsification from such requirements.
More on the EC draft and the Cambodian initiative, as well as links to related documents are available to subscribers on page 2.
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