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March 2022 EMA/377885/2015Rev.3 Veterinary Medicines Divisionalization checklist for initial MAY pharmaceuticals (applicable to submissions under Regulation (EU) 2019/6)1. Background on the product
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Read the instructions and guidelines provided on the webpage
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The www.emaeuropaeu/en/veterinary-regulatory/veterinary-medicinal-products-regulation/european form is needed by individuals or organizations involved in the veterinary industry in Europe.
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What is wwwemaeuropaeuenveterinary-regulatoryveterinary medicinal products regulationeuropean?
The European Medicines Agency (EMA) is responsible for the scientific evaluation, supervision and safety monitoring of veterinary medicinal products in the European Union.
Who is required to file wwwemaeuropaeuenveterinary-regulatoryveterinary medicinal products regulationeuropean?
Manufacturers and distributors of veterinary medicinal products in the European Union are required to file with the EMA.
How to fill out wwwemaeuropaeuenveterinary-regulatoryveterinary medicinal products regulationeuropean?
Companies must complete the necessary forms and provide all required documentation for each veterinary medicinal product.
What is the purpose of wwwemaeuropaeuenveterinary-regulatoryveterinary medicinal products regulationeuropean?
The purpose is to ensure the safety, quality and efficacy of veterinary medicinal products available in the European Union.
What information must be reported on wwwemaeuropaeuenveterinary-regulatoryveterinary medicinal products regulationeuropean?
Companies must report information related to the manufacturing process, composition, safety and efficacy of the veterinary medicinal product.
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