Medicines, medical devices
Services
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Sunset clause: request for public health exemption
Apply for a public health exemption from the sunset clause.
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Apply for a statement of exemption from the MHRA
Apply for a statement of exemption from the Medicines and Healthcare products Regulatory Agency (MHRA).
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Infant formula and foods for medical purposes: notification
Application to notify authorities about the introduction of medical foods and infant formula to the UK.
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Blood facility declaration form
Blood facility declaration form to be completed and returned to MHRA.
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Apply for a nutritional product to be considered by the ACBS
Apply for a nutritional product to be considered by the Advisory Committee on Borderline Substances (ACBS).
Guidance and regulation
- Regulating medical devices from 1 January 2021
- How tests and testing kits for coronavirus (COVID-19) work
- Find product information about medicines
- Registering to make submissions to the MHRA from 1 January 2021
- Clinical trials applications for Coronavirus (COVID-19)
News and communications
- Human and veterinary medicines: register of licensed manufacturing sites
- Human and veterinary medicines: register of licensed wholesale distribution sites
- Medical devices given exceptional use authorisations during the COVID-19 pandemic
- Field Safety Notices: 23 to 27 November 2020
- Oxford/AstraZeneca COVID-19 vaccine: MHRA statement confirming letter received
Research and statistics
- Community Pharmaceutical Services Statistics for Northern Ireland, Quarter 2 2020/21
- Public Assessment Report of the Reclassification of Benacort Hayfever Relief for Adults 64 micrograms, nasal spray from POM to GSL
- Early access to medicines scheme applications: pending, refused, granted
- Weekly Personal Protective Equipment (PPE) Deliveries, Northern Ireland: Week ending 6th March to week ending 30th October 2020
- Medicines: licensing time-based performance measures
Policy papers and consultations
- Isotretinoin: call for information to be considered as part of an expert review
- MHRA draft guidance on the licensing of biosimilar products
- Consultation on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines
- How should we engage and involve patients and the public in our work
- Medicines and Medical Devices Bill: overarching documents
Transparency and freedom of information releases
- Voluntary scheme aggregate net sales and payment information: August 2020
- Health service products and medicines regulations 2018: annual review 2020
- Medicines and Healthcare products Regulatory Agency GPC spending over £500: 2020 to 2021
- Medicines and Healthcare products Regulatory Agency spending over £25,000: 2020 to 2021
- Public Health England (PHE) research involving animals
Organisations
Explore sub-topics
- Clinical trials and investigations
- Conferences and events
- Good practice, inspections and enforcement
- Herbal and homeopathic medicines
- Manufacturing, wholesaling, importing and exporting medicines
- Marketing authorisations, variations and licensing guidance
- Medical devices regulation and safety
- Pharmacy
- Vigilance, safety alerts and guidance