The Office for Life Sciences have published their latest updates. OLS Bulletin - 24 July These include updates on news, including regulatory updates, transitional guidance and events.
adminJuly 28, 2023
Please note this is an extract of the original bulletin. Approved verification: guidance and application form Page summary: Weights and Measures Act 1985 and subsequent Deregulation Order 1999 (as amended). Change made: Register of approved verifiers updated. OPSS enforcement actions Page summary: Enforcement actions from 1 April 2018 to 31 March 2023. Change made: OPSS enforcement actions 1 October to…
adminJuly 28, 2023
Please note this is an extract of the original bulletin. Borderline products: how to tell if your product is a medical device and which risk class applies Page summary: How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device. Change made: An additional section…
adminJuly 21, 2023
The MHRA have recently updated their Guidance on the regulation of In Vitro Diagnostic medical devices in Great Britain to: Reflect the current requirement for UKCA marking (section 3.15) Add UK approved bodies and UKCA mark/marking in the Conformity assessment procedure flow charts (section 3.11) instead of using CE mark/marking and NBs The rest of this document remains the same.…
adminJuly 21, 2023
Please note this is an extract of the original bulletin. Notice to exporters 2023/12: The Export Control (Amendment) Regulations 2023 Page summary: The Export Control Joint Unit (ECJU) has amended the Export Control Order 2008 (“the 2008 Order”) and the retained Council Regulation (EC) No 428/2009. Change made: First published. Notices to exporters Page summary: Notices to exporters published by…
adminJuly 21, 2023
Please note this is an extract of the original bulletin. Balai Directive: approved premises Page summary: Institutes, centres and premises in Great Britain approved to move animals, semen and embryos covered by the Balai Directive. Change made: We have updated the approval dates for Chew Valley Animal Park, Dudley Zoological Gardens, Fernvalley Wildlife Centre, Folly Farm Leisure Limited, AB/17/10/005, Shepreth…
adminJuly 21, 2023
Please note this is an extract of the original bulletin. Taking part in the UK Emissions Trading Scheme markets Page summary: This guidance explains the operation of the UK ETS markets and how to take part in auctions and in trading on the secondary market. Change made: Cost Containment Mechanism figures updated for latest month. Opportunities for economic growth in…
adminJuly 21, 2023
Please note this is an extract of the original bulletin. England Rare Diseases Action Plan 2023 Page summary: The second action plan setting out how the Department of Health and Social Care and delivery partners will implement the UK Rare Diseases Framework in England. Change made: Updated to link to the now published report on the Breaking Down Barriers focus…
adminJuly 21, 2023
HSE have published their latest bulletins: Biocides 17 July: Live online training event delivered by HSE: human health endocrine disruption of pesticides and biocides (27 and 28 September 2023) This event will focus on the toxicological ED assessment of pesticide and biocide active substances and biocide products and will present the current evaluation approach used by HSE. The training…
adminJuly 21, 2023
Please note this is an extract of the original bulletin. UK REACH authorisation for Lonza Biologics Plc: 30 June 2023 Page summary: Decision on application for authorisation under UK REACH. Change made: First published. Authorisation decisions: UK REACH Page summary: Authorisation decisions on the time-limited use of hazardous substances of very high concern under UK REACH. Change made: We updated…
adminJuly 21, 2023