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Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Applications received to amend the specification of a patent under sections 27 and 75 before the court and the Office.
Guidance on labelling for medicinal products used in clinical trials.
The MHRA has today, 26 November 2025, approved inavolisib (Itovebi) for the treatment of adults with a type of breast cancer called HR-positive
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Jan - 31 Mar 2024.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Guidance on using non-investigational medicinal products in a clinical trial.
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
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