Article 47 of Directive 2001/83/EC (Community code relating to medicinalproducts for human use) requires that the EU Commission enforces principles andguidelines of good manufacturing practice for medicinal products and APIs. Thelatter should be adopted in the form of a delegated act (wording of theDirective: "The Commission shall adopt delegated acts ... The principlesof good manufacturing practice for active substances used as starting materialsreferred to in point (f) of Article 46").

Whereas for medicinal products a GMP Directive (Directive 2003/94/EC from 8 October 2003) and detailedguidelines (Part I of the EU GMP Guide) have been existing for 11 years, therehas been no equally binding act in all the EU members states for APIs. Only thedetailed guidelines as Part II of the EU GMP Guide are in place. This has nowbeen caught up on. On 25 November 2014,  the "Commission DelegatedRegulation (EU) No 1252/2014" was published in the Official Journal of the European Union. As the subtitle shows, this regulation is tobe seen as "supplementing Directive 2001/83/EC... with regard toprinciples and guidelines of good manufacturingpractice for active substances  for  medicinal productsfor 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 IIof the EU GMP Guide delivers further concretisation of these principles.

The regulation has been valid since 28 May 2014 but omes into force on thetwentieth day after publication in the Official Journal, i.e. on 15 December2014. It becomes directly applicable in each EU member state (withouttransitional period).

Refer Document: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R1252&from=EN