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UK Government Updates Regulatory Affairs Newsletter Archive

Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA launch statutory fees consultation

The MHRA last week launched a consultation on statutory fees proposals for April 2025 until March 2027. Unsurprisingly, the trajectory is upwards - in some cases (such as clinical trials) significantly. BIVDA’s Head of Policy and Programmes, Paul Fisher noted, "These proposed increases will disproportionately impact SMEs - the sector that the government and NHS recognise as a key part…
Ben Kemp
September 3, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 26 Aug)

DCMS Sectors Economic Estimates Page summary: This series brings together all documents relating to DCMS Sectors Economic Estimates. Change made: Added latest monthly GVA publication. Time updated: 9:30am, 20 August 2024 UK innovation diffusion and adoption survey Page summary: The Department of Science Innovation and Technology (DSIT) is conducting a survey of UK businesses. Help us understand how we can…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 26 Aug)

Get someone to deal with customs for you Page summary: Find out how you can hire a person or business to deal with customs for you. Change made: Guidance updated to make it clear you will still be responsible for due diligence for your customs declarations if you appoint someone to deal with customs for you. Time updated: 2:01pm, 21…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates (WC 26 Aug)

General licences and authorisations to import live animals or animal products Page summary: Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products. Change made: Updated 2 licences:- General licence to import certain products for in vitro use with 10% or less animal by-product carrier or stabilizer…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UKHSA Updates (WC 26 Aug)

Shingles vaccination: guidance for healthcare practitioners Page summary: Information about the shingles vaccination programme aimed at healthcare practitioners. Change made: Clarifications made in the 2 sections about severely immunosuppressed individuals who received Zostavax prior to becoming immunosuppressed. Time updated: 9:30am, 23 August 2024 Smallpox vaccine PGD template Page summary: PGD template for administering smallpox vaccine in response to mpox (monkeypox).…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 26 Aug)

Our governance Page summary: The main decision-making, executive and managerial bodies at the Medicines and Healthcare products Regulatory Agency (MHRA). Change made: Added registration information for next meeting to be held on Tuesday 17 September 2024 Time updated: 10:17am, 23 August 2024 AI Airlock: the regulatory sandbox for AIaMD Page summary: A proactive, collaborative, agile and the first of its…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA Updates (WC 26 Aug)

General licences and authorisations to import live animals or animal products Page summary: Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products. Change made: Updated 2 licences:- General licence to import certain products for in vitro use with 10% or less animal by-product carrier or stabilizer…
Ben Kemp
August 28, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Weekly Update (WC 26 Aug)

Overseas business risk: Honduras Page summary: The overseas business risk report provides information on security and political risks UK businesses may face when operating in Honduras. Change made: The guidance has been reviewed and updated where necessary, Time updated: 1:32pm, 19 August 2024 Overseas business risk for Guatemala Page summary: The overseas business risk report provides information on security and…
Ben Kemp
August 27, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA AI Airlock Webinar from July 2024 available

The MHRA have uploaded their webinar covering the AI Airlock from July, which may be of interest to members. The webinar provides a helpful overview of the utilisation of the Airlock for the development of AI IVDs. It can be accessed here.
Ben Kemp
August 23, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 19 August)

Safety and security requirements on imports and exports Page summary: Find out about safety and security requirements that apply to goods entering and exiting the UK. Change made: References to Customs Handling of Import and Export Freight (CHIEF) system have been removed as all import and export declarations must now be made through the Customs Declaration Service. Time updated: 3:40pm,…
Ben Kemp
August 21, 2024
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