UK MHRA Guidance directory

All uk mhra guidance435 total

• Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework2025-03-11
• Marketing authorisation applications referred under Article 292025-03-11
• Rolling review for marketing authorisation applications2025-03-11
• Conditional marketing authorisations, exceptional circumstances MAs, scientific advice2025-03-11
• Reference medicinal products (RMPs)2025-03-11
• Windsor Framework explainer2025-03-11
• Apply to release a vaccine or a blood product to market2025-03-11
• Advanced therapy medicinal products: regulation and licensing in UK2025-03-06
• AI Airlock pilot cohort2025-02-28
• Format and content of applications for agreement or modification of a Paediatric Investigation Plan2025-02-28
• Guidance on the licensing of biosimilar products2025-02-27
• Licensing plasma master files and vaccine antigen master files2025-02-27
• Market Exploration: Non-Compressible Haemorrhage – Novel Technologies2025-02-25
• Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA2025-02-19
• Registration of in vitro diagnostic devices with expiring CE certificates2025-02-17
• Registration of reusable or upclassified Class I devices and/or expiring CE certificates2025-02-17
• Completed paediatric studies: submission, processing and assessment2025-02-13
• Importing investigational medicinal products into Great Britain from approved countries2025-02-12
• Decision tree for navigating nanotechnology-based products for medical application2025-02-05
• UK-wide licensing for human medicines: supplementary guidance2025-01-31
• Import a human medicine2025-01-29
• Supply unlicensed medicinal products (specials)2025-01-29
• Reporting adverse incidents involving software as a medical device under the vigilance system2025-01-15
• Adverse incidents: in vitro diagnostic (IVD) blood glucose meters2025-01-15
• Breast implants: reporting adverse incidents:2025-01-15
• Reporting adverse incidents: neurostimulators2025-01-15
• Medical devices: how to comply with legal requirements in Great Britain2025-01-15
• Reporting adverse incidents: intraocular lenses2025-01-15
• In vitro diagnostic medical devices: guidance on legislation2025-01-15
• Reporting adverse incidents: joint replacement implants2025-01-15
• Reporting adverse incidents: devices for cardiac ablation2025-01-15
• Reporting adverse incidents: insulin pumps and meter systems2025-01-15
• Applying human factors to medical devices2025-01-15
• Pre-clinical vaccine evaluation2025-01-10
• UKHSA's Vaccine Development and Evaluation Centre (VDEC)2025-01-10
• Supplementary information for pharmacists and medicines procurers on the Windsor Framework2025-01-09
• Supplementary information for pharmaceutical wholesalers on the Windsor Framework2025-01-09
• Guidance on pharmacovigilance procedures2025-01-08
• Pharmacovigilance requirements: qualified person for PV and PSMF2025-01-08
• Guidance on MAH and QPPV location2025-01-08
• Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland2025-01-02
• Guidance on new provisions for traditional herbal medicinal products and homeopathic medicinal products2024-12-31
• Renewing marketing authorisations for medicines2024-12-31
• Procedures for UK paediatric investigation plan (PIPs)2024-12-31
• UK medicines export and Windsor Framework labelling requirements2024-12-30
• Sourcing medicines for the UK market2024-12-30
• Medicine choices in opioid substitution treatment2024-12-27
• Timor-Leste: medical facilities2024-12-23
• Comparator products in bioequivalence/therapeutic equivalence studies2024-12-20
• Unfettered access procedure for marketing authorisations approved in Northern Ireland2024-12-20
• The 2024 voluntary scheme for branded medicines pricing, access and growth: payment percentage for 20252024-12-16
• MHRA Windsor Framework Webinar Recordings2024-11-20
• MHRA Windsor Framework Video Explainers2024-11-20
• Windsor Framework Webinar Recordings2024-11-14
• Advice for producers of e-cigarette and vape products2024-11-13
• Statement of policy intent: relaunch of the Innovative Licensing and Access Pathway2024-11-06
• Advice for Producers of E-Cigarette/Vape Products2024-11-04
• Handling of Active Substance Master Files and Certificates of Suitability2024-10-18
• Report safety concerns with insulin pumps and continuous glucose monitoring equipment2024-10-08
• Pre-submission Advice & Support2024-10-01
• Preventing drug and alcohol deaths: partnership review process2024-09-26
• Access Consortium Generic Medicines Working Group Mandate2024-09-24
• AI Airlock pilot call for applications (closed)2024-09-22
• Ionising Radiation (Medical Exposure) Regulations 2017: guidance2024-09-04
• E-cigarettes: regulations for consumer products2024-08-16
• Chapter 1 - Submission type guidance - Great Britain2024-08-16
• Chapter 3 - Emissions guidance - Great Britain2024-08-16
• Chapter 4 - Nicotine dose guidance - Great Britain2024-08-16
• Chapter 5 - Presentation guidance - Great Britain2024-08-16
• Chapter 6 - Ingredient guidance - Great Britain2024-08-16
• Chapter 7 - Annual reporting guidance - Northern Ireland2024-08-16
• Chapter 7 - Annual reporting guidance - Great Britain2024-08-16
• Chapter 9 - General advice on due diligence - Great Britain2024-08-16
• Chapter 10 - General advice on vigilance - Great Britain2024-08-16
• Chapter 8 - Labelling guidance - Great Britain2024-08-16
• Chapter 1 - Submitting notifications EUCEG guidance - Northern Ireland2024-08-16
• Chapter 1.1 - Submission type guidance - Northern Ireland2024-08-16
• Chapter 3 - Emissions guidance - Northern Ireland2024-08-16
• Chapter 4 - Nicotine dose guidance - Northern Ireland2024-08-16
• Chapter 5 - Presentation guidance - Northern Ireland2024-08-16
• Chapter 6 - Ingredient guidance - Northern Ireland2024-08-16
• Clinical evaluation for vaccines2024-07-16
• Discovery and surveillance2024-07-16
• Partnerships and collaborations on vaccine development and evaluation2024-07-16
• Post-licensure vaccine services2024-07-16
• Services offered by the Vaccine Evaluation and Development Centre (VDEC)2024-07-16
• Machine learning medical devices: transparency principles2024-06-12
• Topical corticosteroids and withdrawal reactions2024-05-29
• How VDEC develops and evaluates vaccines2024-05-19
• Working with UKHSA's expertise2024-05-19
• Medical devices: compliance and enforcement of the regulations2024-05-17
• Medicines: good manufacturing practice and good distribution practice2024-05-13
• Send and receive information on adverse drug reactions (ADRs)2024-05-09
• National coding taxonomy for incident learning in clinical imaging, MRI and nuclear medicine2024-04-22
• User guidance and application of the national taxonomy for incident learning in clinical imaging, MRI and nuclear medicine2024-04-21
• Medical technology innovation classification framework2024-04-08
• Infant and follow-on formula and food for special medical purposes2024-04-03
• Access Consortium2024-02-26
• Guidelines for submitting a nutritional product to the ACBS2024-02-01
• Community pharmacy: delivering substance misuse services2024-01-24