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COVID 19 - Marketing authorization, Variations, Renewal, Sunset Clause

The current COVID-19 pandemic is currently having a huge impact on citizens, patients and businesses.

The ANSM is mobilized on a daily basis in close collaboration with the Ministry of Solidarity and Health and all health stakeholders in the exceptional context of the COVID-19 pandemic.

As a public service and with regards to its mission towards public health, the ANSM has organized itself to meet its essential missions, in particular to ensure the availability and safety of health products and treatments for patients with COVID-19.

This Questions and Answers document (27/04/2020) application/pdf (287 ko)  (Q/A) should be read as an addendum to the recommendations from the European authorities:

>> European Commission

>>  Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) 

This document provides guidance to applicants and marketing authorizations holders for medicinal products for human use on regulatory expectations as well as possible adaptations during the COVID-19 pandemic in line with to those already provided at European level and which is applicable for national procedures.

If needed, this document will be updated to answer new questions and to adapt the content to the evolution of the pandemic. It  remains valid until further notice.

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