Sunset clause: request for public health exemption
Apply for a public health exemption from the sunset clause.
Apply for a statement of exemption from the MHRA
Apply for a statement of exemption from the Medicines and Healthcare products Regulatory Agency (MHRA).
Infant formula and foods for medical purposes: notification
Application to notify authorities about the introduction of medical foods and infant formula to the UK.
Blood facility declaration form
Blood facility declaration form to be completed and returned to MHRA.
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
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- MHRA draft guidance on the licensing of biosimilar products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