UK MHRA Guidance: Navigating on Applying for a Licence to Market a Medicine
MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing
MHRA Guidance: Notify the MHRA about a Clinical Investigation for a Medical Device
UK MHRA: Guidance on 150-Day Assessment for National Applications for Medicines
UK MHRA: Guidance on Operational Information Sharing
UK MHRA: Guidance on Submitting Changes to Labelling and Patient Information Leaflets
UK MHRA Guidance: Apply for a Parallel Import Licence
UK MHRA: Guidance on Register Medical Devices to Place on the Market
UK MHRA: Guidance on Change of Ownership: Marketing Authorisation Process
MHRA Guidance: Common Issues Identified during Clinical Trial Applications
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK
UK MHRA: Clinical Trials for Medicines: Apply for Authorisation in the UK
MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
MHRA MD Guidance: Innovative Devices Access Pathway (IDAP) & How to Notify Clinical Investigation
UK MHRA: Guidance on International Recognition Procedure
UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime
UK MHRA: Guidance on Labelling & Packaging of Medicinal Products - Windsor Framework
MHRA Med Dev Guidance: In-Vitro Diagnostic Medical Devices on Legislation
UK MHRA MD Guidance: Borderlines with Medical Devices & Other Products in Great Britain