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MHRA PMS and Vigilance reporting – Updated UK requirements

Last week, MHRA updated the PMS and Vigilance guidance page. They intend to continue to accept reporting for NI using the EU MIR and will transition to using 7.3.1 as per the EU deadline, however for GB reporting there is a new GB Schema that will be introduced and will need to be used from the date of application of…
Ben Kemp
May 19, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA – Guidance: Intensified Official Controls at the EU Border

Guidance on what happens when Intensified Official Controls are triggered at the EU Border The Department for Environment, Food & Rural Affairs (Defra) has published new guidance aimed at businesses exporting animal products from Great Britain to the European Union. This guidance sets out the procedures and requirements for exporters if their consignments trigger Intensified Official Controls (IOCs) or Imposed…
Ben Kemp
May 15, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Updates (WC 11 May)

Government’s tech reform to transform cancer diagnosis Page summary: Cancer 360 brings patient data into one central system, so clinicians can prioritise those most in need and see patients quicker Change made: First published. Time updated: 12:01am, 4 May 2025 Primary Care Utilisation and Modernisation Fund 2025 to 2026 Page summary: A full list of schemes included in the Primary…
Ben Kemp
May 15, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Energy Security and Net Zero Updates (WC 11 May)

UK ETS 2025 Baseline Data Collection and HSE/USE scheme status: how to meet the data submission requirements Page summary: Guidance for operators on meeting the requirements for the baseline data collection and scheme status application submission window, 1 April – 30 June 2025. Change made: Added UKETS17 FAR: Waste gases and process emissions sub-installations. Time updated: 9:32am, 8 May 2025…
Ben Kemp
May 15, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates (WC 11 May)

Export primate samples to Switzerland: certificate 5527 updated Page summary: Apply online to export primate samples to Switzerland. Change made: EHC now available on Export Health Certificates Online (EHCO) Time updated: 2:38pm, 8 May 2025 Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and…
Ben Kemp
May 15, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates (WC 11 May)

Extended producer responsibility for packaging: report packaging data Page summary: Guidance for organisations who may need to report packaging data because they are affected by extended producer responsibility (EPR) for packaging Change made: Added link to new guidance for small producers. Time updated: 12:07pm, 6 May 2025 Common user charge: rates, eligibility and invoices Page summary: Common user charge rates…
Ben Kemp
May 15, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 11 May)

Notice to Importers 2951: Syria import sanctions Page summary: Overview of import prohibitions in force on certain goods originating or consigned from Syria imported into the UK, including Northern Ireland. Change made: Amended to reflect the Syria (Sanctions) (EU Exit) (Amendment) Regulations 2025, alongside changes to the ‘Trade sanctions licences’, ‘Enforcement of trade sanctions’ and ‘Enquiries’ sections. Time updated: 11:42am,…
Ben Kemp
May 15, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 11 May)

Applications open to bring 25 top tech minds into government, to accelerate AI-driven growth and modernise public sector Page summary: Applications are open for a new round of government fellowships aimed at bringing 25 leading technologists and scientists into public service. Change made: First published. Time updated: 12:01am, 7 May 2025 CHERI technology for cyber security Page summary: CHERI is…
Ben Kemp
May 15, 2025