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How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Find out about the ways people can make certain decisions for you or do certain things on your behalf
Provides information on how the Pharmaceutical Price Regulation Scheme (PPRS) is controlling spend on branded medicines in the NHS.
The process for the simultaneous review of veterinary medicine submissions by New Zealand’s Ministry for Primary Industries (MPI) and the UK's Veterinary Medicines Directorate.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guidance for veterinary medicines manufacturers and wholesale dealers in GB on selling and supplying products placed on the EU and UK markets before 1 January 2021 and the evidence you may need to provide.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
The process for the simultaneous review of veterinary drug submissions by Health Canada’s Veterinary Drugs Directorate and the UK's Veterinary Medicines Directorate.
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