MHRA Update on a No Deal Brexit

26th July 2019

If the UK leaves the EU without a deal, contingency legislation will be needed in order for the MHRA to be able to take on regulatory processes for human medicines and devices that are currently undertaken by the European Medicines Agency and other bodies.

Three separate pieces of legislation will allow for the continued sale of, and access to, medicines, medical devices and clinical trials:

1. Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc) (EU Exit) Regulations 2019
2. The Medical Devices (amendment) (EU exit) Regulations 2019
3. The Medicines for Human Use (Clinical Trials) (amendment) (EU exit) Regulations 2019

These Regulations were approved by Parliament in April 2019.

The Human Medicines and Medical Devices (Amendment etc.) (EU exit) Regulations 2019 was laid in parliament on the 24th July 2019.

This instrument makes a number of changes to the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 to ensure that the UK legislation accurately reflects technical updates at EU level since April 2019 and also corrects drafting errors and omissions to reflect published policy in the event of a no deal Brexit.

An explanatory memorandum can be found here, with the full legislation available here.

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