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Question for Department of Health and Social Care

UIN HL16724, tabled on 26 June 2019

To ask Her Majesty's Government what steps they have taken to assess the impact on the NHS of leaving the European regulatory framework in the event of a no-deal Brexit.

Answered on

10 July 2019

The Government maintains that leaving the European Union with a deal is the best outcome. However, as a responsible Government, we continue to plan and prepare for all eventualities, including a potential ‘no deal’ exit.

The Government is committed to the safe and effective regulation of medicines and medical devices in the United Kingdom. We will continue to strengthen safety while ensuring National Health Service patients and the public have fast access to new, innovative medicines.

The Government is providing short-term regulatory flexibility, in order to ensure that the UK can still import medicines from the European Economic Area (EEA), when the UK leaves the EU. We have announced that, in the event of a ‘no deal’ scenario, the UK will recognise batch testing that takes place in the EU and EEA, thus ensuring regulatory continuity so that the NHS can maintain ease of access to medicines developed and manufactured in the EU.

In the event of a ‘no deal’ exit, the Government will continue to ensure that UK patients are able to access the best and most innovative treatments and that their safety is protected.