What Marketing Authorisation Holders need to know now about their Registrations

On 10 April 2020, the European Medicines Agency (EMA) together with the Heads of Medicines Agencies (HMA) and the European Commission (EC) published a first version of the document "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC", which is continuously updated and adapted.

With this Q&A catalogue, the EMA, HMA and the Commission aim to provide guidance to marketing authorisation holders (MAHs) on regulatory options and adjustments in times of Covid-19 and to facilitate the handling of registration procedures and existing marketing authorisations. In addition to the topics variations and renewals, the document provides information on the handling of sunset clauses or of product information and labelling. Further, the CMDh has issued the "Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis", explaining the topics presented in the Q&A document. This guidance shows and describes practical approaches for the implementation, addressing and the requirements of the measures.

You can also find further information directly in the "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC" - as well as in the "Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis".

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