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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.
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 new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
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 herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Section (4A.01 - 4A.31) last updated October 2023.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
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.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
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