EU falsified medicines directive: imported active substances need written confirmation to guarantee GMP standards

From July 2, 2013, all active substances manufactured outside of the European Union and imported into the EU must be accompanied by a written confirmation from the competent authority of the exporting country which confirms that the standards of Good Manufacturing Practice (GMP) and control of the manufacturing plant are equivalent to those in the EU, the European Medicines Agency has stated.

These requirements constitute one of the main areas of change of the new European falsified medicines directive which came into force in January 2013. They provide a clear legal basis for the concept of international cooperation on active substances (also known as active pharmaceutical ingredients or APIs) which is based on sharing responsibilities with local regulators.

The written confirmation is required per manufacturing site and per active substance and should provide the following assurances: