Regulatory guidance in connection with COVID-19 and impact on assessment times
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.
Both the CMDh and the CMDv 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 all three guidance documents, also for medicines authorised under the purely national procedure.
The COVID-19 pandemic has impact on our assessment times for applications for marketing authorisations, variations, renewals and applications for parallel import. However, at the Danish Medicines Agency we continue to do our best to process the applications within the deadlines.
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
Practical guidance of the CMDv for facilitating the handling of processes during the COVID-19 crisis