ESPL Regulatory Consulting

News

Regulatory News and Updates

BREXIT: Contingency legislation covering regulation of medicines and medical devices in a no deal scenario

Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no deal scenario.

Contingency legislation is needed in order for the Medicines and Healthcare products Regulatory Agency (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.

The 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 have been approved by Parliament and were made in April 2019.

Read more on the HMRA website here.

Ian Abernethy