Coronavirus: new corona agency and joint European regulatory guidance for marketing authorisation holders during the COVID-19 pandemic

The Government is establishing a new corona agency to ensure the availability personal protective equipment and increased test capacity.

At a press conference on 12 May 2020, the Government informed the public that it will establish a new corona agency whose main task is to coordinate the public preparedness across authorities and to create an overview over personal protective equipment in relation to the current COVID-19 pandemic. Thereby, the corona agency is to strengthen the overall effort by the authorities and enable healthcare workers to focus on health-related tasks.

Furthermore, the corona agency is established to prepare Denmark for a possible second wave of the COVID-19 pandemic or a completely new pandemic. The Government expects the new agency to be ready in August.

New joint guidance

The European Commission, the European Medicines Agency (EMA), the Co-ordination Group on the Mutual and Decentralised Procedures (CMD(h)) and the Heads of Medicines Agencies (HMA) issue a joint guidance.

This guidance may be used by marketing authorisation holders during the COVID-19 pandemic. Among other things, the guidance contains information on the following subjects: 

  1. Whether medicinal products intended for use in COVID-19 patients can be marketed in the absence of a marketing authorisation;
  2. Possibility for postponing a renewal application for a marketing authorisation;
  3. Changes in the manufacturing/supply chain to ensure continuity of supplies of crucial medicines for treatment of COVID-19 patients;
  4. Automatic extension of GMP certificates;
  5. Amended quality requirements for medicines intended to be used for the treatment of COVID-19 patients;
  6. Adverse reactions reporting; and
  7. Packaging and labelling.

The entire guidance can be found here.

Simultaneously, the CMD(h) has prepared a practical guidance which should be read in addition to the above guidance and can be seen here.

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