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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.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. The article also includes information on a recent National Patient Safety Alert...
Find out about applications to protect traditional terms related to wine products in Great Britain.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
Check the tariff classification for a defined daily dose of active substances.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Check the tariff classification for preparations put up for retail sale.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
Who in the pharmaceutical industry can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
The way you apply to licence biological products has changed
See the list of applications to protect the geographical name of a food, drink or agricultural product in Great Britain.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
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.
Guidance on applications and licences for manufacturers & wholesalers, suspended and revoked licences, registrations, exporting medicines, defective medicinal products and fees.
How to apply to protect a food, drink or agricultural product name under the UK GI schemes.
Get help to classify organic chemicals that contain certain permitted additives or can be dissolved in water, for import and export.
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