22/23 February 2024
Article 47 of Directive 2001/83/EG (Community code relating to medicinal products for human use) requires that the EU Commission enforces principles and guidelines of good manufacturing practice for medicinal products and APIs. The latter should be adopted in the form of a delegated act (wording of the Directive: "The Commission shall adopt delegated acts ... The principles of good manufacturing practice for active substances used as starting materials referred to in point (f) of Article 46").
Whereas for medicinal products a GMP Directive (Directive 2003/94/EG from 8 October 2003) and detailed guidelines (Part I of the EU GMP Guide) have been existing for 11 years, there has been no equally binding act in all the EU members states for APIs. Only the detailed guidelines as Part II of the EU GMP Guide are in place. This has now been caught up on. On 25 November 2014, the "Commission Delegated Regulation (EU) No 1252/2014" was published in the Official Journal of the European Union. As the subtitle shows, this regulation is to be seen as "supplementing Directive 2001/83/EC... with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use".
Now, the set of rules for APIs is complete: the new regulation provides the necessary legal framework of GMP principles for APIs; the long existing Part II of the EU GMP Guide delivers further concretisation of these principles.
The regulation has been valid since 28 May 2014 but will come into force on the twentieth day after publication in the Official Journal, i.e. on 15 December 2014. It will become directly applicable in each EU member state (without transitional period).