+7(495)665-81-35
+7(843)226-03-63

Animal drugs (medicine) – pharmaceuticals used for treatment or prevention of diseases and enhancement of productivity and zootechnical performance, vaccines, anatoxins, preparations for diagnostic tests, treatment and preventive serums, gamma globulins, probiotics, immunity inducing microbiological agents, microorganisms accumulation sensitive systems, as well as preparations used in artificial insemination and embryos transplantation, antiseptics, disinfection substances, detergents, pest control and rats extermination substances, animal feeds, feed additives and animal grooming aids.

Feed additives (supplements) – substances of organic, mineral and/or synthetic origin used as a supply source of biologically active substances in animals’ nutrition. According to Federal Law No.61-FZ of April 12, 2010 «On the Circulation of Medicines»,

medical substances and feeding additives of veterinary use are the subjects for the State registration.

According to the order of Russian Federation Ministry of Agriculture No.48 of April 01, 2005,

«On Validation of the Rules of State Registration of Animal Drugs and Feed Additives» the following are obligatory for registration:

— new drugs;

— new additives;

— new combinations of previously registered medicines;

— new combinations of previously registered additives;

— previously registered medicines that are produced in new forms or in new dosage or in other

composition;

— previously registered additives that are produced in new forms or in new dosage or in other

composition;

— generic drugs;

— generic additives.

State registration of drugs and additives is conducted by Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) based on report made by federal governmental agency «The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed (hereinafter as «VGNKI»).

AiLFARMA Ltd provides following services:

— telephone and personal consulting;

— documents analysis and file preparation;

— technical documentations development including full technical specifications for registration

file preparation;

— provision of documents’ forms and filling-in consultations;

— file submission to the state agencies;

— laboratory trials/expert study organization, pre-clinical and clinical trials in the course of registration process, issuing the contracts (with VGNKI);

— the file’s modifications and changes when needed;

— receiving letters, bills, regulations, registrations;

— informing on legislative and regulatory changes in product legalization/registration field in the territory of the Russian Federation,

— prompt response to requested services.

AiLFARMA Ltd guarantees full scale supervision of registration procedure from A to Z.



 



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Contacts

Address: c. Moscow, 2-й Syromyatnicheskiy str., д.1
Phone: +7(495)665-81-35
Address: г. Kazan, Pr. Yamasheva 46/33
Phone: 8 (843) 226-03-63 ,
Email:
WhatsApp: +7(495)665-81-35
Skype: ailfarma@mail.ru

AiLFarma - licensing of medicines
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