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UK Government Updates Regulatory Affairs Newsletter

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

DSIT Update (WC 19 August)

AI Upskilling fund Page summary: The AI Upskilling fund pilot scheme will support small and medium-sized enterprises (SMEs) by match-funding AI skills training for their employees. Change made: Added details of a drop-in webinar on Wednesday 14 August 2024. Time updated: 3:32pm, 12 August 2024 Cyber Essentials management information Page summary: Figures showing the number of Cyber Essentials certificates awarded,…
Ben Kemp
August 21, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Update (WC 19 Aug)

UK REACH authorisation for Abbott Laboratories Ltd, 3 July 2024 Page summary: Decision on application for authorisation under UK REACH. Change made: First published. Time updated: 12:00pm, 12 August 2024 UK REACH authorisations for Siemens Healthcare Diagnostics Products GmbH, 3 July 2024 Page summary: Decision on application for authorisations under UK REACH. Change made: First published. Time updated: 12:00pm, 12…
Ben Kemp
August 21, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Update (WC 19 Aug)

Trade barriers: what you need to know Page summary: Find out what trade barriers are and how they may affect you when exporting goods or services. Change made: Link to information about ‘harmful international trading practices’ added to the ‘further information’ section of the page. Time updated: 11:48am, 12 August 2024 CPTPP: impact assessment Page summary: This impact assessment sets…
Ben Kemp
August 21, 2024
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