Analysis of current legislation in the field of introduction into civil circulation of drugs for veterinary use

Abstract

This article analyzes the current legislation in the field of introducing medicines for veterinary use into civil circulation.

The changes described in the regulatory documentation consolidate the key norms and rules governing the registration process of veterinary medicinal products, include registration algorithms that were not previously used, and effective assessment of the safety and quality of drugs before their release to the market.

As a result of the analysis of the current legislation in the field of introducing medicines for veterinary use into civil circulation, 3 fundamental changes were identified:

1) Application of the term “introduction into civil circulation” in relation to drugs for veterinary use;

2) Introduction of the concepts of “an authorized person of the manufacturer of medicines” (for Russian manufacturers) and “a person authorized by the holder or owner of the registration certificate of a medicinal product for veterinary use” (for foreign manufacturers), defining their functions and the procedure for their certification;

3) Obligation for all production sites, regardless of the country of production, to have a Russian GMP certificate.