Get the free Guideline on Active Substance Master File - European Medicines ... - ema europa
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European Medicines Agency Veterinary Medicines and Inspections London, 15 April 2005 EMEA/CAMP/134/02 Rev 1 CAMP/TWP/227/02 Rev 1 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CAMP) COMMITTEE FOR
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What is guideline on active substance?
Guideline on active substance is a set of instructions and requirements for the registration and approval of active substances in pharmaceutical products.
Who is required to file guideline on active substance?
Manufacturers and distributors of pharmaceutical products are required to file guideline on active substance.
How to fill out guideline on active substance?
Guideline on active substance can be filled out by providing detailed information about the active substance, its properties, and its intended use.
What is the purpose of guideline on active substance?
The purpose of guideline on active substance is to ensure the safety, quality, and efficacy of active substances in pharmaceutical products.
What information must be reported on guideline on active substance?
Information such as the chemical structure of the active substance, manufacturing process, impurities, and stability data must be reported on guideline on active substance.
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