Commission Delegated Regulation on GMP for API’S published in the official journal of the EU (European Union)
"Commission Delegated Regulation (EU) No 1252/2014" has been published in the Official Journal of the European Union. This regulation serves as a "supplementing Directive 2001/83/EC with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use.
As there has been no act in all the EU members states for APIs equivalent to that of the medicinal products for which a GMP Directive (Directive 2003/94/EG ) and detailed guidelines (Part I of the EU GMP Guide) have been existing for 11 years, this Commission Delegated regulation was published. For APIs only Part II of the EU GMP Guide were in place. The new regulation provides the necessary legal framework of GMP principles for APIs whereas the Part II of the EU GMP Guide elaborates these principles. The regulation has been valid since 28 May 2014 but will come into effect on 15 December 2014.
Article 47 of Directive 2001/83/EG (Community code relating to medicinal products for Human Use), requires the enforcement of the principles and guidelines of good manufacturing practice for medicinal products and APIs by the EU Commission and also requires that the principles and guidelines should be adopted as a delegated act for API’s .