Extension of Directive 2003/94/EC to GMP for APIs - EC Commission publishes Concept Paper for Comment

Last Friday, the EU Commission published a concept paper to extend Directive 2003/94/EC to GMP for APIs. This had already been announced in Directive 2011/62/EU on the prevention of the entry of falsified medicinal products into the legal supply chain published on 1st July 2011.  According to this Directive, the Commission is obliged to adopt the principles of good manufacturing practice for APIs by means of a delegated act by 2013. As this must be laid down in a directive, it is envisaged to extend the scope of the existing Directive 2003/94/EC on good manufacturing practice for medicinal products to "GMP for APIs".

Nevertheless, not all the requirements of Directive 2003/94/EC are applicable to APIs. The concept paper mentiones the following exceptions:

  • Marketing authorisations: unlike medicinal products, APIs are not subject to a marketing authorisation procedure.
  • Qualified Person: the concept of "Qualified Person" doesn't apply to active substances.
  • Manufacturing authorisations: the manufacturing of active substances is not subject to a manufacturing authorisation.
  • Investigational Medicinal Products: all the requirements for the manufacture of IMPs don't apply to APIs.

In the concept paper, specific provisions regarding APIs - which should be amended - are named. The APIs manufacturers shall be obliged to make sure that the starting material is sourced from the premises claimed by the manufacturer of the starting material.

The document is available for comment until 20 April 2012.

Please see the EU Commission's concept paper "Delegated Act on the Principles and Guidelines of Good Manufacturing Practice for active Substances in medicinal Products for human Use" for further information.

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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