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Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain.
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.
This is the Hub for all the Veterinary Medicines Directorate's communications on current and future regulatory changes.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
If an adverse drug reaction is suspected, ask patients if they are taking any herbal or homeopathic medicines and report any suspicions to the Yellow Card scheme. Remind patients to check that a herbal or homeopathic medicine is licensed and...
Guidance for the pharmaceutical industry on who can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.
Guidance and application forms for Marketing Authorisations, Animal Test Certificates, Veterinary Homeopathic Remedy, Export and Import certificates, Batch release and Batch control.
Definitive fees charged for applications under Schedule 7 of the Veterinary Medicines Regulations 2013.
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
Links to EU guidance, as it stood immediately before end of transition period.
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