Regulatory Affairs Newsletter Archive – Page 118

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APHA weekly update (WC 24 Jun)

Please note this is an extract of the original bulletin. Export rendered protein and/or rendered fat not intended for human consumption to Rwanda: certificate 8855 Page summary: Apply online to export rendered protein and/or rendered fat not intended for human consumption to Rwanda. Change made: First published. Find a professional to certify export health certificates Page summary: A list of…

adminJuly 3, 2024

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Swissmedic weekly update (WC 24 Jun)

Please note this is an extract of the original bulletin. Go-live for the swissdamed Actors module Since 26 May 2021, Swiss economic operators (manufacturers, importers and authorised representatives) have had to register with Swissmedic in order to obtain a unique registration number (Swiss Single Registration Number – CHRN). The Actors module of swissdamed will be available from 6 August 2024. After…

adminJuly 3, 2024

Various pieces of EU legislation amended (June 2024)

A couple EU legislative changes have taken place recently. Notably, these include changes to: Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/ECText with EEA relevance Regulation (EU) 2024/1735 of…

adminJuly 3, 2024

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IMDRF publishes “In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)”

On 25 June, the IMDRF published their updated "In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)." This document sets out significant revisions based on regional policy changes since the last update was published in 2019. The table of contents is designed to support IVD regulatory submissions. IMDRF have confirmed that companion diagnostics are in scope but clinical…

adminJune 25, 2024

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UKHSA weekly update (WC 17 Jun)

Please note this is an extract of the original bulletin. Antimicrobial intravenous-to-oral switch: criteria for prompt switch Page summary: National antimicrobial intravenous-to-oral switch (IVOS) criteria for prompt switch have been developed for adult and paediatric patients, categorised into 5 sections. Change made: Added decision guide for paediatrics.

adminJune 25, 2024

DEFRA weekly update (WC 17 Jun)

Please note this is an extract of the original bulletin. An alternative transitional registration model (ATRm) for UK REACH Page summary: We are seeking views on an ATRm for the UK REACH (registration, evaluation, authorisation and restriction of chemicals) regulation. Change made: Extended the consultation period from 11 July to 25 July due to limited engagement with industry during pre-election…

adminJune 25, 2024

APHA weekly update (WC 17 Jun)

Please note this is an extract of the original bulletin. General licences and authorisations to import live animals or animal products Page summary: Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products. Change made: Updated 2 general licences: – Dog or cat semen from donors compliant…

adminJune 25, 2024

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MHRA weekly update (WC 10 Jun)

Please note this is an extract of the original bulletin. Software and artificial intelligence (AI) as a medical device Page summary: Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD). Change made: Updated guidance to include reference to guiding principles on transparency for machine learning-enabled medical devices…

adminJune 19, 2024

APHA weekly update (WC 10 Jun)

Please note this is an extract of the original bulletin. APHA laboratory test submissions and price lists Page summary: Guidance on the Animal and Plant Health Agency laboratory testing services and prices for animal disease diagnosis. Change made: Updated the Export and ABC price list. Find a professional to certify export health certificates Page summary: A list of organisations in…

adminJune 19, 2024

DEFRA weekly update (WC 10 Jun)

Please note this is an extract of the original bulletin. Transiting animals and animal products through Great Britain Page summary: Rules to follow if you’re moving animals or animal products from one country to another and transiting through Great Britain (England, Scotland and Wales), known as ‘landbridge’ movements. Change made: In the sections on ‘Transits from the EU through Great…

adminJune 19, 2024