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Register as a manufacturer, importer or distributor of active substances.
Register as a manufacturer, importer or distributor of active substances for use in veterinary medicines.
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.
A form of IP that extends the protection of patented active ingredients present in pharmaceutical or plant protection products.
Section (SPP0.01 - SPP21.01) last updated: October 2022.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
The MHRA is continuing to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs)
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Check the tariff classification for a defined daily dose of active substances.
Check what side effects people have reported when they've taken a medicine.
You must get permission to export certain drugs and medicines.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to comply with the exemption from the Veterinary Medicines Regulations that allow certain animal medicines to be sold without a marketing authorisation.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
Advice on ingredients in nicotine-containing liquids in electronic cigarettes and refill containers.
Get help to classify organic chemicals that contain certain permitted additives or can be dissolved in water, for import and export.
Submission dates and how the submissions using the EC decision reliance procedure work.
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