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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.
Advice on ingredients in nicotine-containing liquids in electronic cigarettes and refill containers.
How the MHRA makes decisions on what is a medicinal product (borderline products).
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain.
A form of IP that extends the protection of patented active ingredients present in pharmaceutical or plant protection products.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
Get help to classify organic chemicals that contain certain permitted additives or can be dissolved in water, for import and export.
You can claim relief to pay no Customs Duty and VAT if you're importing therapeutic substances of human origin, blood-grouping or tissue-typing reagents, or related packaging, solvents and accessories.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Patients with recurring lymphoma, or who have not responded to prior treatments, could access a new bispecific antibody therapy to help treat their condition.
Section last updated: April 2024.
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