UK – Guidance on handling of Decentralised and Mutual Recognition Procedures in a no-deal Brexit

This guidance describes the approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP) if there is no-deal Brexit.

At the end of a decentralised procedure with a positive agreement, a national Marketing Authorisation (MA) is issued in all Member States involved. For mutual recognition procedures where the UK is the Reference Member State (RMS), a national (UK) MA has already been granted in the UK before the start of the MRP. For an MRP where the UK is a concerned Member State (CMS), a national (UK) MA is issued if a positive outcome is reached.

Products approved in DCP/MRP on or before exit day with the UK as RMS or CMS

All medicinal products approved in the UK on or before the day the UK leaves the EU via a DCP or MRP have been issued with a national (UK) MA. These MAs will be unaffected and remain valid in the UK. Any subsequent variation to the MA should be submitted as a national variation using current procedures (see separate guidance on variations)…