News about GMP/cGMP


CMDh: Decentralised procedures and mutual recognition during COVID-19

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) of the EMA has published a Q&A for the practical handling of processes for mutual recognition of authorisations during the COVID 19 crisis. 

Explanations and practical guidance are intended to provide support in the application and implementation of the requirements for MR (mutual recognition) and DCP (decentralised procedures) products.

The seven-page document contains 13 questions and answers and clarifies, among other things, the way in which the QP's statement can be given in the case of a new application or a variation. The sole provision of a valid GMP certificate is not sufficient for this purpose. However, under certain conditions desktop audits are possible (Questions 10 and 11).

The Q&A is an addition to the Q&A already published by the European Commission, the EMA, and the HMA on April 10, 2020 (we reported). Further questions and answers have already been added to this Q&A: The document now comprises twelve pages. Questions 2.2, 2.3, 2.4 and 4.1 are new.


CMDh: Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis 

EMA: Q&A on regulatory exspectations for medicinal products for human use during the COVID-19 pandemic