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How to apply for a clinical trial (prior to 28 April 2026) including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Guidance on using non-investigational medicinal products in a clinical trial.
Placing a veterinary medicine on the market, including non-medicinal products, how to obtain advice and report non-compliance.
Explainer for the rules for advertising products used in, on or near animals that are not licensed veterinary medicines.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
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