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International Journal Of Drug Regulatory Affairs
Year : 2023, Volume : 11, Issue : 3
First page : ( 62) Last page : ( 67)
Print ISSN : 2321-7162. Online ISSN : 2321-6794.
Article DOI : 10.22270/ijdra.v11i3.619

Comparative study of regulatory requirements for preparation of dossier for registration of veterinary drug in US, EU and Canada

Raysing Swati, Nerkar Pankaj, Sanghavi Siddhesh, Jogdand Shewta, Patil Atul

R. C. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur, Maharashtra, 425405

Online Published on 29 March, 2024.

Abstract

The main purpose of this article is to research the requirement of the veterinary drug dossier submission in the three countries is US, EU, and Canada and the procedure of all the three countries are different for the submission of the veterinary drug dossier and their rules and regulation are different but all the three countries follow the VICH guidelines in these articles all the information available like necessary documents timeline approval procedure are different for US, EU, and Canada.

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Keywords

Veterinary Drug, Registration, CTD, Ectd, CVM, REP, SMPC, CVMP, VDD.

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