Marketing authorisations, variations and licensing guidance

Services

Sunset clause: request for public health exemption

Apply for a public health exemption from the sunset clause.

Category lists following implementation of the Windsor Framework
- Standard
- 25 March 2025
- Medicines and Healthcare products Regulatory Agency
Apply for a licence to market a medicine in the UK
- Detailed guide
- 11 December 2024
- Medicines and Healthcare products Regulatory Agency
Medicines: packaging, labelling and patient information leaflets
- Detailed guide
- 7 March 2024
- Medicines and Healthcare products Regulatory Agency
Medicines: apply for a variation to your marketing authorisation
- Detailed guide
- 22 April 2024
- Medicines and Healthcare products Regulatory Agency
Medicines: reclassify your product
- Detailed guide
- 20 February 2025
- Medicines and Healthcare products Regulatory Agency

World first as MHRA approves trofolastat for diagnostic imaging of prostate cancer in men聽
- 28 March 2025
- Medicines and Healthcare products Regulatory Agency
- Press release
Orphan registered medicinal products
- 24 March 2025
- Medicines and Healthcare products Regulatory Agency
- Decision
Parallel import licences granted in 2025
- 19 March 2025
- Medicines and Healthcare products Regulatory Agency
- Decision
Marketing authorisations granted in 2025
- 19 March 2025
- Medicines and Healthcare products Regulatory Agency
- Decision
GB marketing authorisations for centrally authorised products
- 11 March 2025
- Medicines and Healthcare products Regulatory Agency
- Decision

Early access to medicines scheme applications: pending, refused, granted
- 8 November 2023
- Medicines and Healthcare products Regulatory Agency
- Official statistics
Medicines: licensing time-based performance measures
- 31 January 2023
- Medicines and Healthcare products Regulatory Agency
- Official statistics
Public Assessment Report of the Reclassification of Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension
- 26 May 2021
- Medicines and Healthcare products Regulatory Agency
- Research
Public Assessment Report of the Reclassification of Almerg 180mg film-coated tablets
- 26 April 2021
- Medicines and Healthcare products Regulatory Agency
- Research
Public Assessment Report of the Reclassification of Allevia 120mg Tablets
- 22 December 2020
- Medicines and Healthcare products Regulatory Agency
- Research

Draft guidance on individualised mRNA cancer immunotherapies
- 3 February 2025
- Medicines and Healthcare products Regulatory Agency
- Closed consultation
- Date closed 31 March 2025
Consultation on proposal to make Aquiette 2.5mg Tablets (oxybutynin hydrochloride) available from pharmacies
- 3 July 2023
- Medicines and Healthcare products Regulatory Agency
- Consultation outcome
- Date closed 13 May 2022
The future strategy for batch testing of medicinal products in Great Britain
- 15 December 2022
- Department of Health and Social Care
- Consultation outcome
- Date closed 26 July 2022