Freedom of Information request on Freedom of Information Request - Post-Brexit definition (FOI 21-027)
Published 24 March 2021
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Thank you for your email.
Please find below answers in blue to the questions you have raised.
1) Are there any planned changes to the definitions of medicines, medical devices and biocides from their current categorisation under Article 1 in the upcoming Medicines and Medical Devices Bill 2019-21? a) If yes, please could you outline what the new definitions for medicines, medical devices and biocides will be?
There are currently no plans to amend the definitions of medicines and medical devices through the Medicines and Medical Devices Bill. The Bill does not enable amendments to be made to the definition of “medicinal product” in the Human Medicines Regulations 2012. The Bill does provide the powers to amend the definition in the Medical Devices Regulation 2002 for “medical device”, should a future need arise, for example to reflect innovative technologies not yet captured in the definition. Biocides are outside the scope of the Bill and are regulated by the Health and Safety Executive.
2) Will the Health & Safety Executive remain the competent authority for inspection / enforcement of biocide regulations post Brexit transition?
This will need to be addressed by the Health and Safety Executive who regulate biocide regulations.
We hope this is helpful.
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Yours sincerely
MHRA Customer Service Centre Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000