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UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences

Earlier today (25 March 2025) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for Manufacturer or Wholesaler of Medicines Licences" and "Regulation of devices in Northern Ireland".

This guidance outlines the process for applying for a licence to manufacture or wholesale medicines in the UK and explains How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.

The wholesale distribution licence, also known as a wholesale distribution authorisation or wholesale distribution licence, is required to sell or supply medicines to anyone other than the patient. To qualify for a wholesale distribution licence, you must follow good distribution practices (GDP) and pass regular GDP inspections.

Also this guidance provides step-by-step instructions on how to prepare and submit an application for a manufacturer or wholesaler licence. It explains the documentation and information required, such as detailed descriptions of facilities, personnel qualifications, and quality management systems.

This guideline provides comprehensive guidance on the regulation of devices, aligning with the EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This also clarifies the regulatory framework for medical devices in Northern Ireland, outlining the requirements for compliance with the MDR and IVDR. It explains how these regulations apply to devices placed on the Northern Ireland market and the role of economic operators in ensuring compliance.

The guidance highlights key changes brought about by the MDR and IVDR, such as increased scrutiny of devices, stricter requirements for clinical evidence, and enhanced post-market surveillance. It also explains the implications of these changes for manufacturers, importers, distributors, and notified bodies.

The major update was to reflect the coming into force of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 and to include information on MDCG guidance on the Health Institution Exemption.


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