Falsified medicines directive: Imported active substances need written confirmation to guarantee GMP standards

From 2 July 2013, all active substances manufactured outside of the European Union (EU) 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.

These requirements constitute one of the main areas of change of the new European falsified medicines directive which came into force in January 2013.

• Primary Source

ESO: Background information: Drug groups warn over new EU law http://www.europeansources.info/record/drug-groups-warn-over-new-eu-law/

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