The requirements of the Falsified Medicines Directive (FMD) relating to unique pack identification have been widely reported, but little attention has been paid to the provisions for tightening the APIsupply chain and applying CMP to certain excipients.The API provisions require EU Member States to ensure that manufacturers on their territory comply with CMP for active substances (to be defined in a delegated act developed by the Cornmission), require them to register importers of APIs from countries outside the EU and set out requirements for importation of APIs from third countries to ensure compliance of the manufacture of APIs with GMP.
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