1. Due to the possibility of a no-deal brexit, the UK MHRA have released detailed guidance on a varity of topics. These are all collated into the “MHRA guidance and publications about a possible no-deal Brexit”

On the 7th and 8th of August the HMRA added 10 new guidances which are listed below:

• Further guidance note on the regulation of medicines, medical devices and clinical trials in a no-deal Brex

• List of approved countries for authorised human medicines if there is a no-deal Brexit

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

• Guidance on Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) in a no-deal Brexit

• Licensing of biological products: biosimilars, ATMPs and PMFs in a no-deal Brexit

• Regulating medical devices in the event of a no-deal Brexit

• Guidance note on new assessment routes in a no-deal Brexit

• Completed Paediatric Studies – submission, processing and assessment in a no-deal Brexit

• Guidance on substantial amendments to a clinical trial if the UK leaves the EU with no deal

• Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit

2. In addition to these guidances the Irish regulatory Authority HPRA has written to all UK based Irish MA Holders, within the last week, seeking confirmation of their readiness to be able to supply in the event of a no-deal Brexit.