On the issue of licensing pharmaceutical activities carried out in the field of circulation of medicinal products for veterinary use
https://doi.org/10.52419/issn2782-6252.2023.1.21
Abstract
The article analyzes data on the provision of public services for licensing pharmaceutical activities in the field of circulation of medicines for veterinary use.
Studied regulatory legal documents on the procedure for licensing. The register of licensees and making appropriate changes to it is maintained by the Federal Service for Veterinary and Phytosanitary Surveillance. In accordance with the established procedure, the Service provides interested persons with information from the Register and other information in this field of activity. Through the Unified Portal of Public Services of the Federal State Information System, applications for the provision of licenses are sent. In electronic form, a request is also made to the licensing authority to amend the Register and terminate the licenses. The use of EPGU for this purpose was introduced from March 1, 2022.
The data of the North-Western Interregional Department of Rosselkhoznadzor in the assigned field of activity for granting licenses, suspension of their validity, renewal and termination of licenses are analyzed.
About the Authors
D. V. Zakhodnova
Diana V. Zakhodnova
, PhD in Veterinary Sciences, Docent
Russian Federation
Russian Federation
R. V. Poyarkova
St. Petersburg State University of Veterinary Medicine;
North-Western Interregional Directorate of Rosselkhoznadzor
Russian Federation
Russian Federation
PhD in Veterinary Sciences
I. I. Shershneva
St. Petersburg State University of Veterinary Medicine;
Russian Federation
Russian Federation
References
1. Zakhodnova, D.V. Licensing of production and pharmaceutical activities in the field of circulation of medicines intended for animals /D.V. Zakhodnova, I.I. Shershneva, D.A. Orekhov // Questions of regulatory and legal regulation in veterinary medicine No. 3-2015, St. Petersburg, SPbGAVM p.51-54.
2. Zakhodnova, D.V. On federal state control (supervision) in the field of circulation of medicinal products for veterinary use. / D.V. Zakhodnova, I.I. Shershneva, A.I. Yaroshchuk, M.V. Vinokhodova // Normative-legal regulation in veterinary medicine, No. 2, 2022, St. Petersburg, SPbGUVM. pp.34-38.
3. Regulations on the licensing of pharmaceutical activities, approved by the Decree of the Government of the Russian Federation of March 31, 2022 No. 547.
4. Decree of the Government of the Russian Federation dated December 2, 2021 No. 2176 “On Amendments to the Decree of the Government of the Russian Federation dated July 30, 2021 No. 1279 “On Conducting an Experiment in the Russian Federation to Optimize and Automate Licensing Processes, including Licensing”.
5. Rules for the formation and maintenance of the register of licenses and the standard form of an extract from the register of licenses, approved by Decree of the Government of the Russian Federation of December 29, 2020 No. 2343.
6. Federal Law No. 99-FZ of May 4, 2011 “On Licensing Certain Types of Activities”.
7. Federal Law of April 12, 2010 No. 61-FZ “On the circulation of medicines”. 8. Shershneva, I.I. Normative-legal regulation of the control of release and circulation of medicines for animals / I.I. Shershneva, D.V. Zakhodnova, M.V. Vinokhodova // Proceedings of the national scientific conference of the faculty, researchers and graduate students of SPbGAVM - St. Petersburg, Publishing House of FGBOU VO SPbGAVM, 2020 pp.114-116.
Review
For citations:
Zakhodnova D.V., Poyarkova R.V., Shershneva I.I. On the issue of licensing pharmaceutical activities carried out in the field of circulation of medicinal products for veterinary use. Legal regulation in veterinary medicine. 2023;(1):21-25. (In Russ.) https://doi.org/10.52419/issn2782-6252.2023.1.21
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