Webb6. In The UK’s approach to the Northern Ireland Protocol, the UK Government set out the essential commitments that needed to be respected in all scenarios: a. Northern Ireland businesses must have unfettered access to the rest of the UK market. b. Trade from Great Britain to Northern Ireland which remained in the UK Webb4 sep. 2024 · Statutory guidance concerning the QPPV for UK authorised products is described in the Good Pharmacovigilance Practices ( GVP) Module I. This guidance will …

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WebbGreat Britain is not part of it – although Northern Ireland is – and imposing its own version risks complicating imports even more. Great Britain therefore lacks any competitive advantage from modernising regulation, and is operating without safety provisions brought in by the EU following scandals such as those affecting breast implants. Webb31 dec. 2024 · If you source a medicine with a marketing authorisation from Northern Ireland for supply to the Great Britain Parallel Import market or for export, you will … hayley henwood on youtube

The Northern Ireland MHRA Authorised Route (NIMAR) - GOV.UK

Webb29 aug. 2024 · What you need to know around the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), additionally theirs implementation in Northern Ireland. Medical devices: EU regulations for MDR and IVDR (Northern Ireland) - GOV.UK Assisted Decision-Making (Capacity) Act 2015 WebbNorthern Ireland and the EU implemented the new EU Medical Devices Regulation (EU MDR) in May 2024 and the new EU in vitro diagnostic regulation (EU IVDR) will apply … Webb30 okt. 2024 · Control of Clinical Trials / Studies. The MHRA guidance confirms that from 1 st January 2024 clinical trial sponsors will still need to register trials in a currently … hayley hennessy