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Ben Kemp

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Changes to NICE regulations: cost-effectiveness threshold – members’ views needed

The UK government has proposed assuming direct control over the cost-effectiveness thresholds used by the National Institute for Health and Care Excellence (NICE), the body responsible for assessing the value of medicines and medical technologies. The proposal applies to both pharmaceuticals and medical devices. Under the proposal, responsibility for setting the threshold would move from NICE’s independent board to government…
Ben Kemp
January 5, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Tell HMRC about insolvency for Plastic Packaging Tax

Tell HMRC about insolvency for Plastic Packaging Tax Page summary: How to report to HMRC if an organisation becomes insolvent for Plastic Packaging Tax purposes, send any final returns and deregister. Change made: Updated the guidance to replace ‘insolvency practitioner’ with a list of roles who can submit the online form. Updated to include that you can use the online…
Ben Kemp
December 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Notice to exporters 2025/33: open general export licences (OGELs) updated

This impacts exports of devices that can be considered ‘dual use’ i.e. could be used for military purposes, such as the creation of chemical or biological weapons. Notice to exporters 2025/33: open general export licences (OGELs) updated The Export Control Joint Unit (ECJU) has updated 8 OGELs. Please see link for details. ECJU's website can be found on GOV.UK
Ben Kemp
December 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Update from GOV.UK for: Radio equipment regulations

Dear members, Remember that NI is following the EU Radio Equipment Directive (RED) including the new cybersecurity requirements that apply to off the shelf equipment, but IVDs and MDs themselves are exempt. RED applies to any devices with wireless capability including Bluetooth, WiFI, Cellular or Near Field Communication such as RFID reading. Radio equipment regulations Page summary: Guidance for businesses…
Ben Kemp
December 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update: WC 15 Dec

Strengthening collaboration between the MHRA and the Department of Health Northern Ireland Page summary: The MHRA and Northern Ireland partners are working together to support innovation, enhance patient safety and ensure people in Northern Ireland benefit from world-class regulation. Change made: First published. Time updated: 11:24am, 9 December 2025 Complaints procedure Page summary: How to make a complaint about a…
Ben Kemp
December 22, 2025
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