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How to carry out a clinical trial to apply for a marketing authorisation, manage your authorisation and report safety issues.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
Apply for an import certificate to import a medicinal product into the UK for veterinary use.
For manufacturers and distributors of intermediate and final feedingstuffs containing a medicinal premix or specified feed additives.
Placing a veterinary medicine on the market, including non-medicinal products, medicinal words and phrases, how to obtain advice, report non-compliance.
The legal text underpinning the regulation of manufacture, authorisation, marketing, distribution, use and post-authorisation surveillance of veterinary medicines and medicated feed.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine etrasimod (Velsipity) to treat people with moderately to severely active ulcerative colitis.
Following MHRA approval of a clinical trial, early breast cancer patients on endocrine-based therapy can benefit from a study with camizestrant.
Requirements for an Animal Test Certificate (ATC) to carry out the field trial of a veterinary medicine in animals (clinical trial) in the UK.
Legal requirements and good practice guidance for Veterinary Practice Premises Inspections.
Correspondence from Home Office ministers or the Secretary of State to the ACMD.
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
This research project aims to develop improved methods for the determination of mycotoxins.
Check the tariff classification for a defined daily dose of active substances.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
This series brings together all documents relating to ACMD drug-specific reports.
The process for the simultaneous review of veterinary medicine submissions by Switzerland’s Swissmedic and the UK's Veterinary Medicines Directorate.
Guidance on applications and licences for manufacturers & wholesalers, suspended and revoked licences, registrations, exporting medicines, defective medicinal products and fees.
Trade remedies protect domestic industries from unfair practices around imports. The UK’s own independent trade policy includes a trade remedies system.
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