MHRA to Issue Guidance for UK Manufacturers in No-Deal Case


If Boris Johnson is named the new UK Prime Minister, many will regard the chance of a no-deal Brexit as an uncomfortably real possibility.

Drugmakers need to prepare accordingly, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance for active substance manufacturers in the UK.

The agency has stressed that, in the event of a no-deal, the UK will be recognized as a third country for the export of active substances for human use to the European Union (EU) and wider European Economic Area (EEA).

Written confirmation will be required for each shipment of active substances manufactured in the UK that is exported to the EEA, the guidance states.