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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect on 23 July 2025.
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.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
For manufacturers and distributors of intermediate and final feedingstuffs containing a medicinal premix or specified feed additives.
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