Amendments to Federal Law “On the Circulation of Medicines“ Entered into Force

| By | Regulatory, Russia, Veterinary drugs
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Russian President Vladimir Putin signed the Federal Law “On Amending Certain Legislative Acts Regarding the Regulation of the Circulation of Medicinal Products for Veterinary Use”. The document is published on publication.pravo.gov.ru.

According to amendments to Federal Law “On the Circulation of Medicines”, the federal executive body Rosselkhoznadzor is vested with the right to conduct a controlled purchase of medicines for veterinary use. Giving Rosselkhoznadzor such a right will make it possible to quickly identify substandard, counterfeit medicines for veterinary use, and cases of violations by pharmaceutical entities engaged in good pharmacy practice.

In addition, the Federal Law specifies:

  • the powers of the federal executive authorities regarding the establishment of the issuance procedure and the form of a document confirming that the medicinal product for veterinary use is approved for circulation in the Russian Federation;
  • the procedure for submitting and considering applications for state registration of a medicinal product for veterinary use;
  • the procedure for the submission by the holder or owner of a registration certificate of a medicinal product of a report on the results of pharmacovigilance;
  • a list of samples of substances used to control the quality of the drug.

According to the changes, the Ministry of Agriculture of Russia is also empowered to approve the procedure for prescribing drugs for veterinary use, the form of prescription forms for these drugs, and the procedure for their registration and storage.

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