Covid-19: Handling of Marketing Authorisations

The EU Pharmaceutical Legislation Reform: Impact on the API Industry

Recommendation

21 October 2025
Barcelona, Spain

The EU Pharmaceutical Legislation Reform: Impact on the API Industry
An ECA Course prior to the 28th APIC/CEFIC Global GMP & Regulatory API Conference

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.