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