COVID-19: Regulatory flexibility

messages in brief | 22/04/2020

In its March 2020 meeting, the CMDh agreed on flexibility with regard to regulatory deadlines as well as the implementation of user tests. Further information can be found on the website of the CMDh in the press release of the March Meeting, in the "Notice to stakeholders: Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic" recently published by the EC, HMA and EMA, and in an additional document of the CMDh ("Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis").

If you have any questions, please contact nat@basg.gv.at.

Furthermore, the EMA website provides an overview of the measures and EMA's involvement in the global fight against SARS-CoV-2.

These links can be also found on the website of the BASG in the section Marketing authorisation & life cycle.

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