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DBT Weekly Update (WC 2 Dec)

Invest 2035: the UK’s modern industrial strategy Page summary: The industrial strategy is the UK government’s proposed 10-year plan for the economy. It aims to deliver the certainty and stability businesses need to invest in the high-growth sectors and drive long-term economic growth. We want to hear your views on our proposals. The final industrial strategy will be published in…
Ben Kemp
December 5, 2024
European Commission Updates Regulatory Affairs NewsletterRegulatory Affairs Newsletter

EU / UK regulation updates – Other legislation

The EU have recast the Liability for defective products directive (EU) 2024/2853, which comes into force 8th December 2024 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024L2853 Note that the maximum timeframe for entitlement for compensation is normally 10 years, but can be up to 25 years (Article 17) – this could impact minimum document retention periods. Additionally, the Recast EU General Safety and Performance Regulation 2023/1828…
Ben Kemp
December 5, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New legislation and amendments to adapt the EU single market in the event of a crisis

The EC have published new legislation to adapt the EU single market in the event of a crisis. It allows for flexibility in continuing to be able to place products on the market under emergency conditions. Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures related to an internal…
Ben Kemp
December 5, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Clinical Trials Guidance

MHRA’s Mark Grumbridge, earlier this month sent out a reminder on LinkedIn about their Clinical Investigation Guidance Page Clinical investigations guidance - GOV.UK which includes links to a useful checklist and updated information on conducting trials in Northern Ireland.
Ben Kemp
December 5, 2024