Saturday, 14 March 2020

Draft Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders


The European Medicines Agency has issued a draft paper titled “Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders”, which is currently out for public comment.


The paper is “focussed on the GMP-related responsibilities that apply to Marketing Authorisation Holder (MAH) companies. While it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products themselves, the current European Commission (EC) guide to GMP (hereafter referred to as the ‘GMP guide’) refers, in several places, to MAHs and their responsibilities in relation to GMP.”

For details see: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-good-manufacturing-practice-marketing-authorisation-holders_en.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

No comments:

Post a comment

Pharmaceutical Microbiology Resources

Special offers