UK MHRA Guidance: How Marketing Authorisation Applications referred under Article 29 are Handled
UK MHRA Guidance: Orphan Medicinal Products, Reference Medicinal Products (RMPs), and Handling of Active Substance Master Files (ASMFs) and Certificates of Suitability (CEP)
UK MHRA Guidance: Conditional Marketing Authorisations, Exceptional Circumstances Marketing Authorisations, and National Scientific Advice
UK MHRA Guidance: Pre-submission Advice & Support
UK MHRA: Guidance on Applying for a Manufacturer or Wholesaler of Medicines Licence
UK MHRA: Windsor Framework: Wholesalers & Manufacturers Guidance & Labelling and Packaging Requirements
UK MHRA Guidance: Clinical Trials for Medicines – Applying for Authorisation in the UK
UK MHRA Guidance: Apply for the Early Access to Medicines Scheme (EAMS)
UK MHRA Guidance: Medicines Pipeline Data and Pre-submission Advice & Support
UK MHRA Guidance: Machine Learning Medical Devices: Transparency Principles
UK MHRA: "AI Airlock" The Regulatory Sandbox for AIaMD
UK MHRA: Guidance on Send and Receive information on Adverse Drug Reactions (ADRs)
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
UK MHRA: Notify MHRA About a Clinical Investigation for a Medical Device
UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation
UK MHRA: Rolling Review for MAA and 150-Day Assessment for National Applications
UK MHRA Guidance: Borderlines with Medical Devices & Other Products in Great Britain
UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences
UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
UK MHRA: Guidance on Established Medicines Marketing Authorisation Application Process Changes