The bill contains amendments to the law “On drugs circulation” (№61-FZ).
According to the document, the outcomes of human medication preclinical studies have to be submitted to launch accelerated authorization procedure for its use in animals. The results of clinical studies can be substituted by a review of scientific data on the effect the medication shows in different animals.
The Rosselkhoznadzor will be in charge of veterinary drugs simplified authorization.
“There are two Registers of medicinal products in Russia – one for human use and another for veterinary use. These registers are maintained by different national authorities. Consequently, in order to allow veterinary clinics or veterinarians to prescribe some human medications to treat animals, they have to be included in the Register of medicinal products for veterinary use,” says the explanatory note to the bill.
The Register of medicinal products for veterinary use contains about 2.000 drugs, and the Register of medicinal products for human use has more than 18.000.
The authors of the bill pointed out, that veterinary medicines have certain limitations. “Medicinal products for veterinary anesthesia used at surgeries may be ineffective, so veterinarians often have to break the law while applying human drugs to avoid the death of an animal from pain shock. Adrenaline, atropine, dopamine, norepinephrine, lidocaine are used in animal resuscitation, but these are all human drugs, used in human medicine. There are no effective alternatives for these drugs in veterinary medicine. The drugs for dental procedures are not included in the Register of medicinal products for veterinary use, as they are not used in livestock treatment, though they are applied widely in treating pets ,” says the explanatory note to the bill.
As Maria Novikova, the director of Department for Veterinary Medicine of Russian Ministry of Agriculture, said in an interview to V&L, there are some manufacturers of sedatives and aesthetics that are willing to have their products authorized for veterinary use.