We are working to support hospital blood banks to focus on service continuity during the COVID-19 outbreak, by offering to provide temporary regulatory flexibility in exceptional circumstances.Blood compliance reportThe submission…
We have also published guidance on Exceptional good distribution practice (GDP) flexibilities for medicines during the outbreakUnexpected deviationsAnnex 16 of GMP provides a mechanism to allow certain ‘unexpected deviations’ in…
Sponsors and researchers developing COVID-19 vaccines are invited to contact the MHRA to discuss their regulatory strategy and plans for filing regulatory submissions in the UK.To support companies’ development plans…
This page was published in 2014 and remains online only as a historical record. For updated information about these medicines, please consult the relevant Summary of Product Characteristics and Patient…
Warning statements need to be added to the labels and leaflets of certain medicines. The words in this guidance do not need to be used verbatim but that have already…
