UK MHRA Guidance directory

All uk mhra guidance435 total

• Updates to CIR 520/2012 – Information for UK Marketing Authorisation Holders2026-02-09
• Good pharmacovigilance practice (GPvP)2026-02-09
• Orphan medicinal products2026-02-06
• GLP-1 medicines for weight loss and diabetes: what you need to know2026-02-05
• Access, new active substance and biosimilar work sharing initiatives2026-01-30
• Submission and assessment timetables for innovative medicines applications2026-01-27
• Safety Public Assessment Reports2026-01-26
• Route B substantial modification pilot2026-01-21
• International Recognition Procedure2026-01-21
• Health Institution Exemption for general medical devices2026-01-20
• MORE Submissions - user reference guide2026-01-12
• Operational Information Sharing2026-01-02
• MMRV Vaccine Factsheet – Information for Parents and Caregivers2025-12-22
• Medical devices: list of UK approved bodies2025-12-18
• Medical devices: legal requirements for specific medical products2025-12-17
• In Vitro Diagnostic roadmap2025-12-15
• Register a homeopathic medicine2025-12-11
• The 2024 voluntary scheme for branded medicines pricing, access and growth: payment percentage for 20262025-12-10
• Centres of Excellence for Regulatory Science and Innovation (CERSIs)2025-12-02
• Vaccine safety – patient factsheet2025-12-02
• RegulatoryConnect2025-11-05
• Regulatory considerations for therapeutic use of bacteriophages in the UK2025-11-03
• Herbal medicines granted a traditional herbal registration (THR)2025-10-28
• Register for the Distance Selling logo2025-10-23
• AI Airlock Sandbox Pilot Programme Report2025-10-16
• Variations to marketing authorisations (MAs)2025-10-16
• AI Airlock Phase 2 Cohort2025-10-15
• Medicines marketing authorisation: change of ownership2025-10-02
• Drugs and pharmaceutical electronic market information tool (eMIT)2025-09-24
• Valproate – reproductive risks2025-09-23
• Request a MHRA speaker at an event or conference2025-09-18
• Supplying take home naloxone without a prescription2025-09-12
• Apply for manufacturer or wholesaler of medicines licences2025-09-12
• Medical devices: standardised post-market surveillance report format2025-09-05
• Medical devices: post-market surveillance requirements2025-09-05
• Medicines: apply for a parallel import licence2025-09-02
• Make a payment to the MHRA2025-09-02
• Breast implants – patient perception of risk research2025-08-25
• Cosmetic Breast Augmentation Risk Awareness Tool2025-08-25
• Cancel a medicine's marketing authorisation or other licence2025-08-14
• Market Exploration: Modelling and Monitoring Conflict Wounds2025-08-12
• Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance2025-08-01
• Pharmaceutical needs assessments: information pack2025-07-31
• Statement of Policy Intent: Early Access to Innovative Medical Devices2025-07-30
• The Yellow Card scheme: guidance for healthcare professionals, patients and the public2025-07-24
• CLOSED AI Airlock Phase 2 application2025-07-17
• MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions2025-07-17
• Digital mental health technology: qualification and classification2025-07-03
• Medical devices: standardised format for the periodic safety update report2025-07-02
• Types of application for marketing authorisations (legal basis of applications)2025-06-30
• Introducing new medicines in the NHS in the UK2025-06-23
• AI Airlock Background2025-06-22
• Medical devices: periodic safety update report2025-06-18
• Device specific vigilance guidance: Coronary Stents and associated delivery systems2025-06-16
• Medical devices: examples of reportable incidents2025-06-16
• Custom-made medical devices in Great Britain2025-06-16
• Device specific vigilance guidance: Inferior vena cava (IVC) filters2025-06-16
• Field safety notice (FSN): what it is and why it's important2025-06-16
• Device specific vigilance guidance: Cardiac Implantable Electronic Devices (CIEDs)2025-06-16
• Device specific vigilance guidance: Artificial Heart Valves2025-06-16
• Field safety notices: guidance for manufacturers2025-06-16
• Electronic Common Technical Document (eCTD) submissions update2025-06-16
• Decentralised manufacture: Clinical Trial Authorisation (CTA) and Good Clinical Practice (GCP)2025-06-10
• Decentralised Manufacture: Labelling2025-06-10
• Decentralised Manufacture: UK Guideline of Good Pharmacovigilance Practices2025-06-10
• Human medicines Modular Manufacture and Point of Care 20252025-06-10
• Decentralised Manufacture: Marketing Authorisation application2025-06-10
• Supplying authorised medicines to Northern Ireland2025-06-09
• Manufacturer’s Online Reporting Environment (MORE)2025-06-09
• MORE implementation2025-06-09
• MORE Registrations - user reference guide2025-06-09
• Risk minimisation measures for medicines2025-06-09
• Clinical trials for medicines: manage your authorisation, report safety issues2025-06-09
• Decentralised Manufacture: The designation step2025-06-09
• Decentralised manufacture: UK Guideline on Good Manufacturing Practice (GMP)2025-06-09
• Documentation for implementation of data requirements under the new Post-Market Surveillance regulations2025-06-08
• Disapplication of Falsified Medicines Directive Safety Features: Requirements for Parallel Imports2025-06-03
• UK parallel import licences following agreement of the Windsor Framework2025-06-03
• E-cigarette and vape advice for retailers / producers2025-06-01
• Chapter 2 - Product type guidance - Northern Ireland2025-06-01
• Chapter 2 - Product type guidance - Great Britain2025-06-01
• Assistive technology: definitions, examples and safe use2025-05-23
• Find a telecare provider2025-05-13
• The Northern Ireland MHRA Authorised Route (NIMAR)2025-05-09
• Reporting to the National Supply Disruption Response (NSDR)2025-04-29
• Advertise your medicines2025-04-11
• Medical devices: information for patients2025-04-02
• Medicines: register as a broker2025-04-01
• Medicines: register to manufacture, import or distribute active substances2025-04-01
• Periodic Safety Update Reports (PSURs) for medicinal products2025-04-01
• Established medicines: marketing authorisation application changes2025-04-01
• Early Access to Medicines Scheme - Information for Applicants2025-04-01
• Exceptional Use Authorisation2025-03-30
• Community Pharmacy Contractual Framework: 2024 to 2025 and 2025 to 20262025-03-30
• Blue Guide: advertising and promoting medicines2025-03-28
• Safety communications concerning medicines, medical devices and other healthcare products2025-03-25
• MHRA graduate scheme2025-03-18
• UK-wide licensing for human medicines2025-03-12
• Advertising and Promotion following agreement of the Windsor Framework2025-03-11
• Wholesalers & manufacturers guidance following agreement of the Windsor Framework2025-03-11