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Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect 23 July 2025.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Guidance on using non-investigational medicinal products in a clinical trial.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
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