Filenews 6 January 2021
The Committee for Human Medicines (CHMP) of the European Medicines Agency (EMA) has issued a recommendation approving the authorisation for the Moderna vaccine. The adoption of the recommendation by the Member States and the adoption of the conditional authorisation by the Commission will follow in the coming hours.
According to the EMA, conditional marketing authorisation is one of the EU regulatory mechanisms to facilitate timely access to medicines that meet an unfulfilled medical need, including in emergencies such as the current pandemic.
"The conditional marketing authorisation is the formal approval of the vaccine, which covers all batches produced for the EU and provides a strong assessment to support vaccination campaigns," the EMA points out.
The product information approved by the CHMP for the vaccine contains prescribing information for healthcare professionals, a package leaflet for members of the public and details of the conditions for approval of the vaccine.
The Commission will quickly follow the relevant procedure for deciding on the conditional marketing authorisation for the vaccine, allowing the development of vaccination programmes across the EU.
Source: eyenews/KYPE
