BRIEF—MHRA grants CMA for Merck's Lagevrio

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a conditional marketing authorization for US pharma giant Merck & Co’s COVID-19 drug Lagevrio (molnupiravir) in Great Britain and a temporary Regulation 174 authorization for Northern Ireland to ensure supply across all of the UK.

If the European Medicines Agency grants a CMA for Lagevrio it would apply in Northern Ireland and the Regulation 174 authorization would no longer be in place.

Supply of this product will be subject to the same requirements in Great Britain and Northern Ireland, and the product information on this applies to both authorizations.

The information for healthcare professionals and UK recipients on using Lagevrio safely will be periodically updated as new data become available and this will continue when the CMA is converted to a marketing authorization.