New import controls were implemented on 30 April 2024. This email gives you operational information on the Border Target Operating Model (BTOM). Common Health Entry Documents – Good Practice to reduce delays Estimated Time of Arrival (ETA) in IPAFFS Resources to help you comply Contact points for urgent BTOM queries Common Health Entry Documents What is a CHED? A Common…
Ben KempDecember 16, 2024
Critical Communication Notifying BSI of Changes to the Post-market Clinical Follow-up (PMCF) and Post-market Performance Follow-up (PMPF) Plans There is currently a lack of guidance on what constitutes a substantial change to a PMCF/PMPF plan. To address this gap and to provide clarity for our clients, BSI has issued this communication setting out our expectations. For MDR and IVDR devices…
Ben KempDecember 16, 2024
The European Commission announced the publication of a new set of frequently asked questions (FAQs), aimed at helping support investors in the implementation of the EU Taxonomy, its classification system for defining sustainable economic activities. According to the Commission, the publication is aimed at making the Taxonomy easier to use, and forms part of its efforts to reduce the administrative…
Ben KempDecember 16, 2024
AI Airlock pilot cohort Page summary: An overview of the five technologies selected for the AI Airlock pilot. Change made: First published. Time updated: 9:00am, 4 December 2024 MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach Page summary: The pilot scheme, AI Airlock, is designed to help test and improve the rules for…
Ben KempDecember 16, 2024
Using export health certificate (EHC) online: certifier guidance Page summary: Guidance for Official Veterinarians (OVs) and Food Competent Certifying Officers (FCCOs ) on registering for EHC Online and certifying export health certificates. Change made: First published. Time updated: 9:30am, 2 December 2024 How to apply for an export health certificate (EHC) Page summary: Guidance for exporters in England, Scotland and…
Ben KempDecember 16, 2024
DMCCA 2024: turnover and control regulations Page summary: Consultation on draft legislation to be made under powers provided for by the Digital Markets, Competition and Consumers Act (DMCCA) 2024 regarding turnover and control. Change made: List of respondents added to consultation response. Time updated: 4:56pm, 2 December 2024 New plans revealed to save small firms £22,000 a year and improve…
Ben KempDecember 16, 2024
Request for information on substances proposed as persistent organic pollutants (POPs) 2024 Page summary: Request for information to feed into a draft Risk Profile, and draft Risk Management Evaluation for 2 chemical substances proposed as POPs to the UN’s POP Review Committee. Change made: The request for information has ended and comments have been received. Time updated: 4:18pm, 4 December…
Ben KempDecember 16, 2024