Fake medicines import control document released
Form must be filled in by importers of medicines made by non-EU manufacturers as part of anticounterfeiting drive
The European Commission has released a proposed form that must be filled in by importers of medicines made by non- EU manufacturers, as part of a drive against counterfeit pharmaceuticals.
Under EU Directive 2011/62/EU on falsified medicinal products, medicine imports into the EU must be accompanied by documents from an official regulator proving that they contain active ingredients made to EU standards.
Only pharmaceuticals from manufacturers in trusted countries, as approved by the European Commission, can escape this red tape. For others, a form will have to be submitted with imports, a template for which is now being circulated by the Commission for comments by the industry.
The aim, said a Brussels note was to ensure that the ‘plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the EU’.
Comments should be submitted to sanco-pharmaceuticals-d6@ec.europa.eu by June 1.