New GMP Implementing Act published

[Sergey]

The EU Commission has published a new public consultation on an Implementing Act on GMP principles and guidelines for medicinal products for human use.

The introduction to the document sets out the reasons for change:

"Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2 2001 on the Community code relating to medicinal products for human use provides in 1st paragraph of Article 47 an obligation for the Commission to adopt principles and guidelines of good manufacturing practice for medicinal products for human use in the form of a Directive.

This delegation is the legal basis for Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.

However, Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC3 requires that the Commission adopt delegated acts to specify the principles and guidelines of good manufacturing practice and the detailed arrangements for inspection for ensuring the quality of investigational medicinal products.

It is therefore necessary that Directive 2003/94/EC is repealed and replaced by a Delegated Act on principles and guidelines of good manufacturing practice for investigational medicinal products with its legal basis as Article 63(1) of Regulation (EU) No 536/2014 and a new Implementing Directive on principles and guidelines of good manufacturing practice for medicinal products for human use with 1st paragraph of Article 47 of Directive 2001/83/EC as its legal basis.

With this public consultation, the Directorate-General for Health and Food Safety seeks the view of stakeholders regarding the content of a new Implementing Directive on principles and guidelines of good manufacturing practice for medicinal products for human use."

For details see: EMA