Comparative study of Regulatory requirement for preparation of Dossier for Registration of Veterinary Drug in US, EU and Canada

  • Swati Raysing R. C. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur, Maharashtra 425405
  • Pankaj Nerkar
  • Siddhesh Sanghavi R C Patel Institute of Pharmaceutical Education & Research Shirpur
  • Shewta Jogdand
  • Atul Patil
DOI https://doi.org/10.22270/ijdra.v11i3.619

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.

Keywords: Veterinary Drug, Registration, CTD, eCTD, CVM, REP, SMPC, CVMP, VDD

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References

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How to Cite
Raysing, S., P. Nerkar, Siddhesh Sanghavi, S. Jogdand, and A. Patil. “Comparative Study of Regulatory Requirement for Preparation of Dossier for Registration of Veterinary Drug in US, EU and Canada”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 3, Sept. 2023, pp. 62-67, doi:10.22270/ijdra.v11i3.619.
Issue
Vol 11 No 3 (2023): VOLUME 11, ISSUE 3, 2023
Section
Review
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