ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of December 31, 2013 No. 1474

About modification and amendments in the order of the Government of the Republic of Kazakhstan of May 31, 2012 No. 711 "About approval of Rules of import and export of medicines, products of medical appointment and medical equipment"

The government of the Republic of Kazakhstan DECIDES:

Bring in the order of the Government of the Republic of Kazakhstan of May 31, 2012 No. 711 "About approval of Rules of import and export of medicines, products of medical appointment and medical equipment" (SAPP of the Republic of Kazakhstan, 2012, No. 54, the Art. 729) the following changes and amendments:

in Rules of import of the medicines, products of medical appointment and medical equipment approved by the specified resolution:

state Item 3 in the following edition:

"3. Import of medicines and pharmaceutical substances (further - medicines) from the states which are not state members of the Customs union is performed according to the Regulations on procedure for import to customs area of the Customs union of medicines and pharmaceutical substances approved by the decision of Board of the Eurasian economic commission of August 16, 2012 No. 134;

1) of item 4 to state the subitem in the following edition:

"1) proper production practice - the national standard in the field of drug circulation, products of medical appointment and medical equipment establishing requirements to production organization, production process and monitoring procedure in case of production of medicines, products of medical appointment and medical equipment;";

5, of 6, 7 to state Items in the following edition:

"5. When importing to the territory of the Republic of Kazakhstan of medicines from the states which are not state members of the Customs union, their room is performed under customs procedures according to the decision of Board of the Eurasian economic commission of August 16, 2012 No. 134.

6. Import of medicines, including from the states which are not state members of the Customs union (including unregistered) in non-commercial purposes for private use by physical persons, workers of diplomatic corps or representatives of the international organizations, for treatment of passengers and members of crews of the vehicles, crews of train and transport drivers who arrived to customs area of the Customs union for treatment of participants of the international cultural, sporting events and participants of the international expeditions is performed without the permission of authorized body.

7. Execution of the conclusion (the allowing document) for import to the territory of the Republic of Kazakhstan of the unregistered medicines (including when importing the unregistered medicinal substances made in the conditions of proper production practice), the registered medicines intended for clinical trials, the humanitarian assistance (assistance) or the help in case of emergency situations and approval of the medicines registered in the Republic of Kazakhstan is performed by authorized body or its territorial subdivisions in form, according to appendices 1, 2 and 9 to these rules.";

in Item 8:

the paragraph one to state in the following edition:

"8. For execution of the conclusion (the allowing document), approval on import of the medicines registered in the territory of the Republic of Kazakhstan the applicant submits the following documents to authorized body:";

third the subitem 1) to state the paragraph in the following edition:

"the copy of the certificate on state registration (re-registration) as the individual entrepreneur - for physical persons or the copy of the reference (certificate) on state registration (re-registration) - for legal entities;";

third the subitem 2) to state the paragraph in the following edition:

"the copy of the certificate on state registration (re-registration) as the individual entrepreneur - for physical persons or the copy of the reference (certificate) on state registration (re-registration) - for legal entities;";

3) to state the subitem in the following edition:

"3) for prevention and/or elimination of effects of emergency situations:

statement;

the copy of the certificate on state registration (re-registration) as the individual entrepreneur - for physical persons or the copy of the reference (certificate) on state registration (re-registration) - for legal entities;

the copy of the agreement (contract) or invoice (delivery note) with transfer into the state or Russian languages;

the letter from local executive bodies on emergency situation;

the inventory of the submitted documents.

For review import of the medicines registered in the territory of the Republic of Kazakhstan (except for subitems 1-3 of Item 8) the applicant submits the following documents to territorial subdivisions of authorized body:

statement;

the copy of the license for occupation pharmaceutical activities with appendix on subspecies of the activities connected with production of medicines or with wholesale of medicines or the copy of the license for implementation of medical activities by the organizations of health care (in case of import of medicines by the organization of health care);

the copy of licenses and appendix to the license for occupation types of activity in the field of drug trafficking, psychotropic substances and precursors (in case of import of the medicines containing drugs, psychotropic substances and precursors);

the copy of the agreement (contract) with indication of regulations on realization of the imported medicines only in the territory of the Republic of Kazakhstan, and also the copy of the specification with indication of the producer and the country of the producer of medicines with transfer into the state or Russian languages;

the copy of the certificate on state registration (re-registration) as the individual entrepreneur - for physical persons or the copy of the reference (certificate) on state registration (re-registration) - for legal entities;

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