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Register as a manufacturer, importer or distributor of active substances.
A form of IP that extends the protection of patented active ingredients present in pharmaceutical or plant protection products.
You must get permission to export certain drugs and 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.
The MHRA is continuing to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs)
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
VICH consultation on the guideline relating to good manufacturing practice for active pharmaceutical ingredients used in veterinary medicinal products.
Check the tariff classification for a defined daily dose of active substances.
How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
How the MHRA makes decisions on what is a medicinal product (borderline products).
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
How to comply with the exemption from the Veterinary Medicines Regulations that allow certain animal medicines to be sold without an authorisation.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Submission dates and how the submissions using the EC decision reliance procedure work.
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