Europe

Government publishes guidance on regulation of medicines and clinical trials in case of a no-deal Brexit

Guidance on how medicines, medical devices, and clinical trials will be regulated if the UK leaves the EU with no withdrawal agreement has been .

In a ‘no-deal’ Brexit, the UK’s participation in the European regulatory network would cease, and the Medicines and Healthcare products Regulatory Agency (MHRA) would take on the functions currently undertaken by the EU for medicines on the UK market. This would require changes to UK law via the Human Medicines Regulations 2012.

The MHRA is planning a public consultation on some of the major proposed legislative changes.

The UK would recognise CE-marked medical devices approved for the EU market. If this were to change in the future, adequate time would be provided for businesses to implement any new requirements, the government said.

The 2004 regulations for clinical trials will remain in force, modified using powers under the EU (Withdrawal) Act to ensure they still work in the UK after exit.

New EU clinical trials regulations (CTR) that are being developed will not be in force in the EU when the UK exits the EU, and so will not be incorporated into UK law on ‘exit day’ under the terms of Act.

But the government said the UK “will align where possible with the CTR without delay” when the regulations come into force in the EU.

Citation: The Salvadore DOI: 10.1211/PJ.2018.20205465

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