Covid-19: Handling of Marketing Authorisations
Recommendation
Tuesday, 24 February 2026 10.30 - 15.45 h
Focus on CADIFA and obtaining a Brazilian GMP certificate
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
The processes and procedures relating to marketing authorisations are still strongly influenced by the corona pandemic. On the website of the HMA (Heads of Medicines Agencies) this has been reiterated and the available templates and information to facilitate and manage marketing authorisations and registration procedures have been consolidated and listed.
In addition to the continuously updated catalogue"QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC", the "Template for submission of an application for a Covid-19 exeptional change management process (ECMP)" and the "Template for Step 3 Notification of implementation" are available here.
The overview of the information provided and application templates can be found on the website of the HMA (Heads of Medicines Agencies) in the section CMDh.
Related GMP News
10.12.2025Guideline for CEP Revisions published for Comment
10.12.2025Revised Q&As for Centralised Procedures - Post-authorisation
09.12.2025Updated Q&As for Centralised Procedures - pre-authorisation procedural advice
01.10.2025Updated Classification Guideline Published
16.09.2025EMA updates IRIS Documents
16.09.2025eSubmission: Update to the 'PLM Portal eAF - Release Notes'