The law establishes a simplified official registration procedure for the authorized human drugs to be used in animals.
In order to register a human drug as a veterinary pharmaceutical, the manufacturer has to submit the results of a preclinical study of the corresponding medicinal product. The report on the results of a clinical trial will be substituted by a review of scientific research results on the usage of the drug in the intended animal species.
Rosselkhoznadzor is responsible for the registration of veterinary drugs. As Veterinary Medicine and Life was informed in the press service of the Rosselkhoznadzor, the simplified registration procedure will take 45 working days instead of 120.
There are currently two national registers of authorized medicines in Russia: one for medicinal use and one for veterinary use. The register of veterinary medicinal products includes about 2,000 entries, while the register of medicinal products for human use contains more than 18,000 items.
The facts of the unofficial usage of human drugs in animals were stated earlier in the explanatory note to the document.
“Veterinary products used for animal anesthesia during operations proved to be inefficient, which encourages veterinarians to use human drugs in violation of the law. Otherwise, the animal may die because it is unable to endure the neurogenic shock. In the resuscitation of animals, adrenaline, atropine, dopamine, norepinephrine, and lidocaine are used, but all these are drugs for medical use, intended for the treatment of humans. There are no medicines with the same effectiveness in veterinary medicine. Dental medications also aren’t included in the register of veterinary medicinal products, as they aren’t used in farm animals but are quite relevant in pets,” says the explanatory note.