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DHSC and DExEU publish plans for no-deal Brexit

Will government plans ensure supplies continue to reach UK patients?

Government officials have revealed their plans for ensuring supplies of medicines and medical devices continue following a possible no-deal Brexit on the 29 March 2019.

Secretary of State for Health and Social Care Matt Hancock has written to NHS organisations, GPs, community pharmacies and service providers.

Also, Secretary of State for Exiting the European Union Dominic Raab has issued a series of statements covering: quality testing of medicines, blood and blood products, medicines, medical devices, clinical trials, and organs, tissues and cells.

The DHSC is asking pharmaceutical companies to create additional six-week stockpiles of medicines in addition to their usual stock levels. However, NHS organisations are forbidden from stockpiling. Any over-ordering of medicines by NHS organisations will be investigated.

The DExEU has announced that the UK will recognise medical devices approved for the EU market and CE-marked.

Marketing authorisations for most medicines will continue to apply, and all European Medicines Agency centrally authorised products will automatically be converted into UK MAs on 29 March 2019, although manufacturers will be required to provide the appropriate data.

For new products, Medicines and Healthcare Products Regulatory Agency (MHRA) authorisation will be required but, in many areas, it is clear EMA decisions will be considered.

Suppliers will need to establish a UK-based named individual who can be contacted in the event of a safety issue. The MHRA will be able to require independent re-testing or withdrawal of a product from the market. Suppliers will also require a UK-based qualified person for pharmacovigilance (QPPV).

In a ‘no deal’, new UK systems of regulation and incentives for paediatric medicines and orphan medicines will be established, following consultations.

The UK will continue to accept batch testing of human medicines carried out in countries on a list from the MHRA, and will require a UK, EU or EEA-based appointed qualified person to certify batch testing.

Imports of blood or blood components from the EU for transfusion will require a description of activity to receive authorisation.

On clinical trials, the existing 2004 Regulations will remain in force and the UK will in future align with the upcoming EU Clinical Trials Regulation (CTR) 536/2014.

Limits on numbers of doctors and nurses who can be employed through the tier 2 visa route have been removed and the EU structural and investment fund projects are to be underwritten by the UK Government up to 2020.

Further information Letter to the health and care sector: preparations for a potential no-deal Brexit Regulating medicines and medical equipment