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

Author (Corporate)
Series Title
Series Details 02.07.13
Publication Date 02/07/2013
Content Type

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.

Source Link Link to Main Source http://www.emea.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/07/news_detail_001840.jsp&mid=WC0b01ac058004d5c1
Related Links
ESO: Background information: Drug groups warn over new EU law http://www.europeansources.info/record/drug-groups-warn-over-new-eu-law/

Subject Categories ,
Countries / Regions