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DHSC Updates (WC 16 Feb)

Reporting to the National Supply Disruption Response (NSDR) Page summary: Information on how to request assistance from the NSDR. Change made: Updated to promote earlier contact with the NSDR in a disruption response situation. Time updated: 10:01am, 11 February 2025 Government ramps up efforts to end HIV transmissions in England Page summary: Over 20,000 self-testing and self-sampling kits will be…
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 16 Feb)

AI Growth Zones: expression of interest Page summary: Regional authorities, local authorities and industry are invited to submit an expression of interest for the development of AI Growth Zones. Change made: First published. Time updated: 12:01am, 10 February 2025 Government fires starting gun on AI Growth Zones to turbocharge Plan for Change Page summary: Thousands of new jobs are set…
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 16 Feb)

Notice to Importers 2953: Russia import sanctions Page summary: Import prohibitions in force under the Russia Sanctions Regulations 2019, as amended. It should be read alongside the statutory guidance. Change made: ‘Import licences’ section of ‘NTI 2953: Russia import sanctions’ updated to advise when a licence cannot be granted. Time updated: 11:39am, 10 February 2025 Import controls Page summary: How…
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Updates (WC 16 Feb)

Regulations: Nagoya Protocol on access and benefit sharing (ABS) Page summary: Guidance for those conducting research and development on genetic resources. Change made: Minor updates made, including to the OPSS address, and obsolete leaflet removed. Time updated: 4:04pm, 12 February 2025
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: Upcoming active substance renewals and dossier submission deadlines

Apply for active substance renewal by the deadlines to keep products on the GB market 29 May 2025 5-chloro-2-(4-chlorphenoxy)phenol (DCPP) (CAS 3380-30-1 EC 429-290-0) in product types 1, 2 and 4 27 August 2026 Citric acid (CAS 77-92-9 EC 201-069-1) in product type 2
Ben Kemp
February 21, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update from BIVDA’s 2025 Regulatory Affairs Seminar

BIVDA welcomed Dr Rob Reid and Nadine Neale from the MHRA to BIVDA's Regulatory Affairs Seminar last week. They provided updates on the latest MHRA activity including the MHRA Fees consultation, GB Post Market Surveillance, the Pre-Market SI Consultation, and the AI Airlock Pilot, which members will find useful. We have outlined all updates below: MHRA Fees Consultation – The…
Ben Kemp
February 19, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update (WC 10 Feb)

Current approaches to product marking Page summary: Guidance on product marking, including the continued recognition of certain EU requirements, such as CE marking, for specific product sectors. Change made: First published. Time updated: 7:00am, 3 February 2025 MHRA asks for views on proposed guidance to support the safe regulation of new personalised cancer therapies   Page summary: The draft MHRA…
Ben Kemp
February 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 10 Feb)

Using harmonised standards for placing CE marked products on the GB market Page summary: If you rely on the continued recognition of EU requirements, including CE marking, and have used a harmonised standard without an identical GB designated standard, you may need to take specific actions. Change made: First published. Time updated: 7:00am, 3 February 2025 Current approaches to product…
Ben Kemp
February 18, 2025