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Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Urgent and clinically significant safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
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.
Information on comparator products used in studies supporting abridged marketing authorisation application.
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Who in the pharmaceutical industry can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
Don’t include personal or financial information like your National Insurance number or credit card details.
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