New Version of the Q&A Catalogue published

Recommendation

20/21 February 2024
Munich, Germany

GMP meets Regulatory Affairs
Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective

Again, the question and answer catalogue "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC" of the Heads of Medicines Agencies (HMA), European Medicines Agency (EMA) and the European Commission (EC) has been extended and updated. This third version additionally lists points 4.2-4.4 and includes an update of point 2.2.

The question and answer catalogue provides instructions on the current handling of marketing authorisation procedures and existing marketing authorisations and informs about the handling of variation procedures or marketing authorisation renewals. Additional guidance and practical approaches to these issues can be found in the "Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis".

Here, you will find the latest version of the "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC" and the corresponding explanations of "Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis".