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UK Government Updates Regulatory Affairs Newsletter Archive

Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA: Intermediate products – Import Information Notes

Intermediate products – Import Information Notes Page summary: Guidance for vets, importers and border control officials when importing intermediate products to Great Britain. Change made: Updated to clarify that unprocessed raw material is not considered an intermediate product. Also updated guidance on required documentation. From 30 April 2025, EU traders can choose to use importer declarations for these products. From…
Ben Kemp
September 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Reminder: Defra is consulting on extensions to transitional registration deadlines

Defra UK REACH Consultation: extension of transitional registration deadlines The Defra UK REACH Consultation on the extension of transitional registration deadlines is still open. Defra want to hear your views on government proposals to extend: the UK REACH deadlines for businesses to submit dossiers for transitional registrations the dates for HSE (the UK REACH agency) to carry out compliance checks…
Ben Kemp
September 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA – Border Trade Newsletter – getting it right at the border 28 08 25

Getting it right at the border  This newsletter from the Animal and Plant Health Agency (APHA) covers the latest operational updates on requirements and border controls for importing live animals, germinal products, products of animal origin and animal by-products into Great Britain. In this newsletter: IPAFFS Scheduled Update - Monday, 1 September ABP importer declarations Extra border checks cancelled ahead…
Ben Kemp
September 8, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes updated Government Response to the Consultation on Statutory Fees for medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) published an update to the Government Response to the MHRA Consultation on Statutory Fees for medical devices yesterday. This follows a consultation in 2024 which proposed fee increases which would have made many in vitro diagnostic products unviable for the UK market. BIVDA were supported by members to respond to the consultation…
Ben Kemp
September 3, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA updated clinical trials guidance for companion diagnostics

Following BIVDA's feedback to the MHRA, on August 22nd the Government's Clinical Trials Guidance page was updated. The update includes specifics of trial submission when companion diagnostics are involved in GB. Separate IVDR related guidance applies to trials conducted in Northern Ireland. You can find the latest guidance here.
Ben Kemp
September 2, 2025
Near Patient Testing Working PartyRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UK MHRA CDx guidance for clinical trials updated 22AUG2025

Dear members, following our feedback to the MHRA, on August 22nd the Clinical Trials Guidance page on gov.uk was updated. The update includes specifics of trial submission when companion diagnostics are involved in GB. Separate IVDR related guidance applies to trials conducted in Northern Ireland. Thanks to Alison Gillies, Leica Biosystems who spotted and reported the update, which I don’t…
Ben Kemp
August 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Updates (WC 25 Aug)

AI to cut paperwork to free up doctors’ time for patients Page summary: Patients and frontline staff could see huge benefits from new AI helping people out of hospital quicker and slashing bureaucracy. Change made: First published. Time updated: 10:30pm, 16 August 2025 AI Exemplars programme Page summary: AI Exemplars are transforming public services – improving healthcare, education, planning and…
Ben Kemp
August 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Environment, Food & Rural Affairs Updates (WC 25 Aug)

Extended producer responsibility for packaging: templates for sampling and inspection plans Page summary: If you are required to apply for registration as a reprocessor or exporter of packaging waste under extended producer responsibility (EPR) for packaging, and to apply for optional accreditation, you must submit a sampling and inspection plan using these templates. Change made: This adds the overseas reprocessing…
Ben Kemp
August 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates (WC 25 Aug)

Ceri Morgan Appointed Trade Commissioner for Europe Page summary: Ceri Morgan Appointed as His Majesty’s Trade Commissioner for Europe Change made: First published. Time updated: 12:01am, 18 August 2025 Northern Ireland science and tech industries boosted by over £30 million from UK Industrial Strategy Page summary: Major win for Northern Ireland’s high-tech sectors from the UK’s modern Industrial Strategy, supporting…
Ben Kemp
August 28, 2025
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