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is therefore necessary that Directive 2003/94/EC is repealed and replaced by a Delegated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."
Posted by Tim Sandle
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