NCE defends the interests of manufacturers of veterinary drugs in EEC

The agricultural unit of the National Chamber of Entrepreneurs of Kazakhstan "Atameken" suggested to the Eurasian Economic Commission to minimize the demands in the field of veterinary drugs.

As stated the expert of the Secretariat of the AIC Committee of NCE RK Bolat Seisenov, who participated at the recent meeting of the Working Group of the Eurasian Economic Commission in Moscow, 20 fundamental amendments of the Kazakh side were taken into account in drafting of documents on a common approach to the treatment of veterinary drugs.

According to him, at a meeting of the Working Group of EEC were considered the issues of formation of unified approaches to the treatment of drugs for veterinary use on the territory of the Customs Union and the Single Economic Space. In addition, it was noted that work will continue to finalize the draft Rules to regulate the handling of veterinary medicinal products at the customs territory of the EAEU.

As noted Bolat Seisenov, Secretariat of the AIC Committee of NCE RK "Atameken" made proposals to simplify the requirements for the pharmaceutical manufacturing of veterinary medicinal products, as proposed regulations were aimed at increasing complexity of procedures for issuing licenses and certificates in the field of production, registration and trade of veterinary drugs. Big number of requirements, according to representatives of NCE, is not constructive, it will not bring any effect in the area of ​​trafficking and production of veterinary products, in addition to more red tape in business processes.

In Kazakhstan there is now a trend towards reduction of types of licenses, which simplify process of doing business.

"Currently in our country there are only two types of licenses. In the first case, it concerns the production of veterinary products, that is, the enterprise, whether it is a biofactory or a biokombinat must obtain licenses to conduct their activities. And the second - is the right to carry out veterinary and sanitary examination of meat and slaughter products on the market "- said the expert of NCE. According to Bolat Seisenov, these types of licenses are sufficient to do business in this area, in other cases it was decided to limit by permissions and inclusion in the roster of the local executive bodies.

At the meeting of the working group of EEC, representatives NCE RK stated that in Kazakhstan it will be retained at the national level. Representatives of the Working Group of Belarus and the Ministry of Agriculture of the Russian Federation agreed with the proposal of the Kazakhstani business community.

The opinion of NCE RK "Atameken" was taken into account, and now the Commission introduced in draft Rules, regulating the circulation of veterinary medicinal products at the customs territory of the EAEU, proposals voiced by representatives of the Kazakh working group.

We also managed to convince EEC that the customs territory of the EAEU should be established a transitional period until 2025 in the introduction of GMP - Good Manufacturing Practice Rules to be applied in respect of veterinary medicinal products on the whole of the customs territory of the EAEU.

"The experts agreed that the rules of good manufacturing practice of EAEU (GMP) will be applied to veterinary medicinal products at the customs territory of the EAEU. In addition, there will be approved rules, regulating circulation of veterinary medicines and will be established a transitional period in relation to GMP for veterinary medicinal products that allow manufacturers of domestic drugs to carry a gradual shift of production (2025) to good manufacturing practices within EAEU (GMP)”, - said Bolat Seisenov. According to him, currently in Kazakhstan there are no companies in the veterinary field, which have implemented GMP. This is a rather expensive procedure, and Kazakh enterprises, adopting standards GMP, need support or guarantees from the state. Meanwhile, the expert of NCE said that in Russia there are already 30 companies, which have implemented GMP.

At a EEC meeting in Moscow, experts of NCE raised another painful question of diagnostic tools to identify particularly dangerous animal diseases when importing livestock.

"When importing animals from countries near and far abroad there are situations on suspicion of the presence of exotic animal diseases. And the problem is that due to lack of testing, we cannot carry out a diagnostic study. Moreover, according to domestic law, for the test, we need to get a registration, which can take up to 3 months. And during this time the infection can spread to the entire batch of imported cattle, and even lead to its death. More memory tragedy in northern Kazakhstan, when it emerged that the cattle imported from Europe was infected with Schmallenberg virus. Veterinarians were lost in conjectures, Russian specialists suspected viral diarrhea. During this fuss, in other countries was launched diagnostics, time was lost. As a result, the Government of the Republic of Kazakhstan, in order to prevent epidemics, decided to destroy all infected cattle", - said the expert of NCE, adding that more than 700 heads of cattle were burned.

According Bolat Seisenov, there are two types of diagnostics, which are used in contact with the animals -in vitro, and contactless - in vivo, where there is no risk of contamination. Experts of NCE RK "Atameken" offered to EEC to exclude the diagnostics in vivo, and their opinion was heard.

"The Working Group adopted a consensus on the registration of diagnostics tools for veterinary purposes, which are applied directly on the body of the animal (in vivo). It was decided to apply veterinary medicinal products to these diagnostic tools by introducing respective requirements and procedures. With respect to diagnostic tools (in vitro), it was decided to establish uniform framework requirements within the Union with the ability to use the national requirements of Member States for the production, storage, sale, etc.", - said Bolat Seisenov.

The representative of NCE said that by 2019 will be developed a separate volume pharmacopoeia articles for medicines for veterinary use, which will harmonize the pharmacopoeia of the Member States of EAEU. But today there is a single registry of drugs and feed additives for EAEU members, containing information on all registered veterinary drugs on the territory of the Member States of the Union.

"Almost all of the comments and suggestions made to the draft were taken into account in the formation of the Draft Rules, regulating circulation of drugs and feed additives for use in animal husbandry in the Customs Union. In general, more than 20 substantive and relevant comments and suggestions were included in the final version of the draft Rules", - said the expert of the Secretariat of the AIC Committee NCE "Atameken" Bolat Seisenov.

Karlygash ZHUSUPBEKOVA