The Office for Life Sciences have published their latest updates. OLS Stakeholder Bulletin - 12 April These include updates on news, including regulatory updates, transitional guidance and events.
adminApril 17, 2024
Multiple EU and UK legislative changes have taken place recently. Notably, these include changes to: EU legislations: Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of…
adminApril 17, 2024
Please note this is an extract of the original bulletin. Notify the MHRA about a clinical investigation for a medical device Page summary: How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Added Combined review of a CTIMP and Medical Device section and accompanying guidance Combined IMP Device guidance Borderlines…
adminApril 17, 2024
BSI are looking for experts in the field of electrical equipment for measurement, control and laboratory use, specifically for IVD equipment (BS EN 61010-2-101:2017, BS EN 61010-2-101:2017), to join their committee EPL/66 in developing the above standard which is undergoing a revision. BIVDA members who may be interested in joining this committee are requested to contact Regulatory@bivda.org.uk.
adminApril 17, 2024
Please note this is an extract of the original bulletin. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Added Medway Park Veterinary Centre to the list of professionals who can…
adminApril 10, 2024
Please note this is an extract of the original bulletin. Government response to the Regulatory Horizons Council report on neurotechnology Page summary: Minister for Science, Research and Innovation and Minister of State for Health and Secondary Care have responded to recommendations made by the Regulatory Horizons Council on the regulation of neurotechnology. Change made: First published. …
adminApril 10, 2024
Please note this is an extract of the original bulletin. UK & United States announce partnership on science of AI safety Page summary: The UK and US have signed a Memorandum of Understanding which will see them work together to develop tests for the most advanced AI models. Change made: First published. Collaboration on the safety of AI: UK-US memorandum…
adminApril 10, 2024
Please note this is an extract of the original bulletin. Trade with Canada Page summary: How you import from and export to Canada. Change made: Amendment to rules of origin sections on EU cumulation and origin quotas to reflect expiry of these time-limited clauses. Notice to exporters 2024/06: updates to UK strategic export list Page summary: The UK strategic export…
adminApril 10, 2024
Please note this is an extract of the original bulletin. MHRA Windsor Framework Page summary: New Guidance in accordance with the Windsor Framework Change made: First published. UK Parallel Import Licences Following Agreement of the Windsor Framework Page summary: On this page we provide information on UK Parallel Licences following the Agreement of the Windsor Framework. Change made: First published.
adminApril 10, 2024