UK MHRA Guidance directory

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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