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.

Sources:

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