COVID-19: Regulatory guidance in connection with COVID-19 and possible impact on assessment times

14 May 2020

The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) – a network for the national drug regulatory authorities in the EU/EEA – have prepared common regulatory guidance for marketing authorisation holders. The guidance can be used during the COVID-19 pandemic and describes situations in which the authorities will apply flexibilities during the pandemic.

The CMDh has prepared practical guidance to be read in conjunction with the first-mentioned guidance and which applies to medicines submitted under the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP).

The Danish Medicines Agency follows both guidance documents, also for medicines authorised under the purely national procedure.

At the Danish Medicines Agency, we are doing our best to keep the time allowed for assessment of applications for marketing authorisation, variations and renewals. But it cannot be excluded that the COVID-19 pandemic may impact our possibilities to keep the assessment times.

Links

Guidance from the European Commission, EMA and HMA:

Notice to stakeholders – Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic

Guidance from the CMDh:

Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis

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