Ben Kemp – Page 216 – BIVDA Newsletter

Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive Upcoming Events Regulatory Affairs Newsletter Upcoming Events Regulatory Affairs Newsletter Archive

Registration now open for webinar on Implementing the new UK Clinical Trials regulations

The Medicines and Healthcare products Regulatory Agency (MHRA), in partnership with the Health Research Authority (HRA), is hosting a short webinar to introduce our joint plans to share draft guidance with stakeholders and to set out the anticipated timelines for implementing the new UK Clinical Trials regulations. If you sponsor clinical trials or are an interested stakeholders from academia or…

Ben KempOctober 1, 2024

Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

IP Connect newsletter – September 2024

International UK reinforces commitment to global IP collaboration in talks with Singapore The IPO lead global dialogue on IP in August, during the 13th annual IP Week in Singapore event. The IPO hosted a high-profile event at Eden Hall titled 'From Intellectual Assets to Capital: The Branding and Innovation Edge'. The discussion, featuring the IPO's Interim Chief Analyst, Rich Corken,…

Ben KempOctober 1, 2024

FDA updates Regulatory Affairs Newsletter FDA Updates Regulatory Affairs Newsletter Archive Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive

Draft FDA Guidance on ACA Basic Safety and Essential performance on MD electrical equipment

You can find the guidance here.

Ben KempOctober 1, 2024

Environmental Newsletter Environmental Newsletter Archive UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

Packaging EPR labelling delay

DEFRA have announced a temporary delay in the introduction of mandatory packaging labelling requirements in the UK. Official announcement below. This supersedes our previous announcement regarding packaging labelling, and we will continue to monitor for updates as they become available in 2025. Please note that DEFRA intend releasing a number of implementing statutory instruments to the Extended Producer Responsibility throughout…

Ben KempOctober 1, 2024

Environmental Newsletter Environmental Newsletter Archive European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive

Get Prepared for the 2025 EU PCN Inspections

Finished IVDs are exempt from Poison Center Notifications, and the requirements for products to have a Unique Formular Identification, however research Use Only and Vet Use products which are not IVDs are in scope: Background Article 45 of CLP requires importers and downstream users to notify hazardous mixtures to the appointed bodies (i.e. poison centers) using the harmonized format (Annex…

Ben KempOctober 1, 2024

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IFRS Foundation Launches Guide to Help Companies Voluntarily Apply ISSB Sustainability Reporting Standards

The IFRS Foundation announced today the publication of a new guide aimed at helping companies to voluntarily apply the International Sustainability Standards Board’s (ISSB) recently issued climate and sustainability-related disclosure standards and communicate their progress to investors. Find out more here.

Ben KempOctober 1, 2024

Other Updates Regulatory Affairs Newsletter Other Updates Regulatory Affairs Newsletter Archive Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive

Article 16(4) certification – relabelling and repackaging activities by importers and distributors

This following would apply to members based in Northern Ireland conducting these tasks, or members distributors, performing these tasks in the EU: Article 16(4) Certification Scheme As part of BSI’s commitment to ensuring patient safety while supporting timely market access to global medical device technologies, we are pleased to inform you that we are expanding our Notified Body services to…

Ben KempOctober 1, 2024

Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

UKHSA Conference 2025

UKHSA Conference 2025 Page summary: Save the date for the UKHSA Conference 2025. Hosted at Manchester Central on 25 to 26 March in partnership with the Faculty of Public Health (FPH). Change made: Updated ‘submit an abstract’ as the submission period has now closed. Time updated: 12:30pm, 25 September 2024

Ben KempOctober 1, 2024

Environmental Newsletter Environmental Newsletter Archive European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive

Commission adopts EU-wide restriction on PFAS subgroup

On 19 September 2024, the European Commission adopted a restriction on undecafluorohexanoic acid (PFHxA), its salts and related substances. This restriction will start applying from 10 April 2026 onwards. PFHxA may be used in various consumer products, including clothing, footwear and cosmetics. These substances are very persistent in the environment and can contaminate soil, drinking water and seas. The restriction…

Ben KempOctober 1, 2024

Environmental Newsletter Environmental Newsletter Archive European Chemicals Agency Updates Environmental Newsletter European Chemicals Agency Updates Environmental Newsletter Archive

Introduction to ECHA’s guidance on new CLP hazard classes

Are you impacted by the classification of substances under the CLP Regulation? This webinar gives an overview of the new ECHA guidance on the recently introduced hazard classes under the Classification, Labelling and Packaging (CLP) Regulation. The updated guidance has been developed by experts from ECHA, EU Member States, EU level non-governmental organisations and associations as well as other nominated…

Ben KempOctober 1, 2024