Applications for authorisation of COVID-19 treatments are made centrally to the European Medicines Agency (EMA). If the EMA concludes that the benefits of a treatment outweighs its risks in treating COVID-19, it makes a recommendation to the European Commission to grant either a marketing authorisation or a conditional marketing authorisation. Once the European Commission grants a marketing authorisation for a medicine, this is valid and legally binding across all EU Member States, including Ireland.
Ireland, through the HPRA, is an active participant in all EMA reviews. The HPRA contributes directly to the assessment of all new medicines and the monitoring of their safety once in use. This is also the case for COVID-19 treatments.
The EMA website contains further information about the development, evaluation and approval of COVID-19 treatments.
The tables below outlines the current status of a treatment in the EMA approval process and links to product information for approved treatments.
The product information includes the:
The following medicines can be used in the EU to treat COVID-19:
Treatments under evaluation
The EMA is currently evaluating the following COVID-19 treatments
*The European Medicines Agency (EMA) may review COVID-19 medicines under Article 5(3) of the Regulation establishing the EMA (Regulation (EC) No 726/2004).
This is intended to support national decision-making on the possible use of these medicines before a formal authorisation is issued.