NHS ramps up guidance for 'no deal' Brexit
While uncertainty remains about if and when the UK will leave the EU - with or without a deal - health sector preparations for readiness to leave with ‘no deal’ have been ramped up.
New official guidance from NHS England and the MHRA has been issued on how to best prepare in event of a ‘no deal’ Brexit includes:
- Letter from Professor Keith Willett, EU Exit Strategic Commander and Medical Director for Acute Care and Emergency Preparedness at NHS England on the operational response that NHS England is undertaking in preparation for a ‘no-deal’ scenario
- Guidance for procurement/prescribers and guidance for patients on accessing medicines
- Guidance on the actions to take to ensure continuity of processing and sharing of personal data
- Updated advice for UK travellers on the continuity of reciprocal healthcare arrangements.
For manufacturers, the MHRA has added further ‘no deal’ guidance to its online collection, including:
- Guidance on Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences
- How renewals of Marketing Authorisations will be handled in a no deal scenario
- Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on exit day
- Licensing of biological products: biosimilars, ATMPs and PMFs
- Converting CAPs to UK Marketing Authorisations (MAs), 'grandfathering' and managing lifecycle changes
- Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products
- Guidance on how variations to Marketing Authorisations (MAs) will be handled after exit day
- Guidance on handling of Decentralised and Mutual Recognition Procedures
- Guidance on how medical devices will be regulated and new guidance on the actions to take to safeguard the availability and supply of medical devices and clinical consumables.