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How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Information on good laboratory, manufacturing and distribution practice, good pharmacovigilance practice (GPvP), out-of-specification investigations, inspection metrics and fees.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Ten guiding principles that can inform the development of Good Machine Learning Practice (GMLP).
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Links to EU guidance, as it stood immediately before end of transition period.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
Comply with good pharmacovigilance practice and prepare for an inspection.
A list of herbal ingredients which are banned or restricted for unlicensed medicines.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
Guidance for industry on flexible approaches we are taking on good distribution practices.
Legal terms for veterinary medicines, marketing of non-medicinal products including medicinal words and phrases, how to complain.
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
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