GMP for APIs


Directive 2003/94/EC is well known and is often referred to colloquially as the ‘GMP directive’. ¬†With the recent directive (2011/62/EU) signifying increasing focus on falsified medicines and therefore more control on starting materials, excipients and APIs, the need to extend the scope of 2003/94/EC to include APIs is required.

The delegated act to amend the scope of 2003/94/EC to include APIs and hence facilitate the amending directive 2011/62/EU on 2001/83/EC is now open for public consultation

Some points of interest:

  • The API manufacturer is required to ensure the starting materials used in the API they manufacture are indeed from the site stated.
  • Confirmation of exceptions from the scope and specific definitions for inclusion.

To open the consultation on the proposed delegated act, please click HERE

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This consultation is now closed