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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.
Summary of the latest safety advice for medicines and medical device users
Guidance on labelling for medicinal products used in clinical trials.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Jan - 31 Mar 2024.
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
As with any medicine, the MHRA will keep the safety and effectiveness of mirdametinib under close review.
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