ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of August 5, 2013 No. 444

About approval of the Technical regulation "About Safety of Veterinary Medicines"

According to the Law of the Kyrgyz Republic "About bases of technical regulation in the Kyrgyz Republic" the Government of the Kyrgyz Republic decides:

1. Approve the enclosed Technical regulation "About Safety of Veterinary Medicines".

2. To the Ministry of Agriculture and Land Reclamation of the Kyrgyz Republic, the State inspectorate for veterinary and phytosanitary safety under the Government of the Kyrgyz Republic to bring the acts into accord with the Technical regulation approved by this resolution.

3. To impose control of execution of this resolution on department of agro-industrial complex and ecology of Government office of the Kyrgyz Republic.

4. This resolution becomes effective after six months from the date of its official publication. This resolution is effective before entry into force in the territory of the Kyrgyz Republic of the corresponding technical regulation of the Customs union.

Approved by the Order of the Government of the Kyrgyz Republic of August 5, 2013, No. 444

Technical regulation "About Safety of Veterinary Medicines"

Chapter 1. General provisions

1. This Technical regulation "About Safety of Veterinary Medicines" (further - the Technical regulation) determines mandatory requirements to all (imported) on territory of the Kyrgyz Republic veterinary medicines, processes of their production, storage, transportation, realization, use and utilization (destruction) made (made) and imported.

The list of objects of technical regulation is given in appendix 1 to the Technical regulation.

2. The veterinary medicines arriving in the address shall correspond to this Technical regulation, and also other regulatory legal acts which action extends to them. At the same time veterinary medicines shall undergo assessment procedure of compliance to requirements of this Technical regulation. The veterinary medicines non-compliant to the requirements of this Technical regulation shall not be marked by mark of conformity to this Technical regulation and are not allowed to placement in the market.

3. This Technical regulation does not extend to prototypes of the veterinary medicines imported for carrying out state registration and also to the drugs made of genetically modified raw materials.

4. In this Technical regulation the following concepts and determinations are used:

active pharmaceutical ingredient (active substance, pharmaceutical substance, active ingredient) - the substance of plant, animal, biotechnological or synthetic origin having pharmacological activity, intended for production and production of veterinary medicines and determining their efficiency;

pharmaceutical institution - veterinary pharmaceutical warehouses, drugstores, pharmaceutical Items;

safety of veterinary medicines, production processes and use - lack of the unacceptable risk connected with possibility of harming of life animals, health of the person and the environment;

biologically active agents - the substances of different origin which are potential sources in case of receipt of veterinary medicines:

defective products - the products which lost quality owing to inadequate storage conditions, transportations non-compliant to the requirements of the regulating documentation, officially revealed and documentary fixed;

balk - product - the dosed medicine which passed all stages of engineering procedure of production of medicine except final packaging;

secondary package - packaging in which the primary package is located;

returned products - the finished goods returned to manufacturer or the distributor;

the owner of the registration certificate - the legal entity who is responsible for production, quality, safety and efficiency of veterinary means;

excipient - pharmacological not active agent of the organic or not organic nature which is used in medicine production process for giving of physical and chemical properties;

intra production supervision - (technological, interoperational) carried out in course of production for the purpose of control and in case of need adjustment of parameters of engineering procedure in order that products conformed to the established requirements;

release in parameters - system of release which, being based on information collected in production process and based on compliance to specific requirements of proper production practice regarding release in parameters, provides guarantees that products have required quality;

preclinical (not clinical) trial - the physical, chemical, biological, microbiological, pharmacological, toxicological and any other research conducted for the purpose of obtaining by scientific methods of estimates and proofs of efficiency and safety of veterinary medicine, which is not including experiments on animals;

the distributor - the legal entity who conducts procurement of products at the seller or the producer and organizes its subsequent realization on retail prices in network of pharmaceutical institutions, based on the agreement (contract), on condition of observance of regional exclusive policy of the seller or the producer of these products. The distributor can perform the activities as from the, and not on its own behalf, but at own expense;

the applicant - the legal entity or physical person which submitted the application for state registration and confirmation of conformity of veterinary medicine in the Kyrgyz Republic;

the application instruction - officially the approved instruction attached to packing unit of veterinary medicine intended for specialists and containing information necessary for the correct use of veterinary medicine;

quality of veterinary medicine - set of the properties giving to veterinary medicine capability to satisfy consumers according to the appointment and to meet the requirements established by the regulating document;

contamination of veterinary medicines - mixing of several types, different series / batches of veterinary medicines or substitution of one type of products by another in case of storage and transportation;

the international not patent name - the shortened scientific name of veterinary medicine on the basis of active ingredient;

proper laboratory practice (Good Laboratory Practice, GLP) - rules of the organization of process and conditions under which preclinical (not clinical) trials are planned, carried out, controlled are regulated, remain and their data are documentary drawn up;

proper production practice (Good Manufacturing Practice, GMP) - rules of production of veterinary medicines on industrial enterprise;

substandard veterinary medicines - the veterinary medicines not suitable for use, owing to discrepancy to the established requirements;

promotion of veterinary medicines - complex of the actions of promotional and informational and motivational nature performed by the pharmaceutical companies;

intermediate products - partially processed products which shall pass the subsequent stages of engineering procedure before it becomes finished goods;

producer of veterinary medicine the legal entity who performs at least one of production phases of veterinary medicine, including packaging;

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