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MHRA Newsletter February 2025 - content. govdelivery. com Welcome to your February 2025 edition of MHRA News The essential industry newsletter where we update you on our most recent activities To keep hearing from us with future editions, register here
Guidance on changes to the clinical trials regulations To help you understand and prepare for the new requirements, we have developed guidance that outlines the changes: This guidance sets out the changes to the REC and MHRA review process for CTIMPs in line with the new clinical trials regulations
Feb 2025: MDCG Planning, MHRA Guidance more - Casus Consulting Below is an overview of the February 2025 news items that were not already individually reported Please see our Regulatory Updates main page for those topics, e g , the EU draft amendment to eIFU legislation, MDCG 2019-6 revised to clarify ‘structured dialogues’ with Notified Bodies, and more
Brexit guidance change explorer - govukdiff. njk. onl Updated to reflect the changes to UK legislation implementing new arrangements for medicines following agreement of the Windsor Framework, and the European Union updates to GVP module XVI
Volume 18 Issue 7 February 2025 - GOV. UK The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices work and are acceptably safe
UK Medical Devices Regulations 2025: Key Amendments Impact The Medicines and Healthcare products Regulatory Agency (MHRA) plans to implement new UK Medical Device Regulations between 2026 and 2027, introducing measures such as implant cards, unique device identifiers, and an international reliance scheme for medical devices
UK MHRA Guidance: Exceptions and Modifications to the EU Good . . . The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on pharmacovigilance requirements that apply to UK Marketing Authorisation Holders (MAHs) following Brexit This guidance outlines key modifications and exceptions to the EU Good Pharmacovigilance Practices (GVP), ensuring regulatory compliance under UK