ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 13, 2019 No. KR DSM-73

About introduction of amendments to the order of the Minister of health and social development of the Republic of Kazakhstan of August 17, 2015 No. 668 "About approval of Rules of import to the territory of the Republic of Kazakhstan of medicines, products of medical appointment and medical equipment and export from the territory of the Republic of Kazakhstan of medicines, products of medical appointment and medical equipment"

According to Item 1 of article 80 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" I ORDER:

1. Bring in the order of the Minister of health and social development of the Republic of Kazakhstan of August 17, 2015 No. 668 "About approval of Rules of import to the territory of the Republic of Kazakhstan of medicines, products of medical appointment and medical equipment and export from the territory of the Republic of Kazakhstan of medicines, products of medical appointment and medical equipment" (it is registered in the Register of state registration of regulatory legal acts at No. 12096, it is published on October 13, 2015 in information system of law of Ad_let) (further - the Order) the following changes:

state heading in the following edition:

"About approval of Rules of import to the territory of the Republic of Kazakhstan of medicines and medical products and export from the territory of the Republic of Kazakhstan of medicines and medical products"

state Item 1 in the following edition:

"1. Approve:

1) Rules of import to the territory of the Republic of Kazakhstan of medicines and medical products according to appendix 1 to this order;

2) Rules of export from the territory of the Republic of Kazakhstan of medicines and medical products according to appendix 2 to this order.";

state appendices 1 and 2 in edition according to appendices 1 and 2 to this order.

2. To provide to committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days from the date of state registration of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "Institute of the legislation and legal information of the Republic of Kazakhstan" for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

4) within ten working days after state registration of this order submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2) and 3) of this Item.

3. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

4. This order becomes effective after ten calendar days after day of its first official publication.

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of May 13, 2019 No. KR DSM-73

Appendix 1

to the Order of the Minister of health and social development of the Republic of Kazakhstan of August 17, 2015 No. 668

Rules of import to the territory of the Republic of Kazakhstan of medicines and medical products

Chapter 1. General provisions

1. These rules of import to the territory of the Republic of Kazakhstan of medicines, medical products (further - Rules) are developed according to Item 1 of article 80 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) and determine procedure for import of medicines and medical products to the Republic of Kazakhstan.

2. Import of medicines from the states which are not state members of the Eurasian Economic 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.

3. In these rules the following basic concepts are used:

1) the document confirming humanitarian character of load to the receiver - the agreement, invoice (delivery note), the invoice, the agreement (contract), the specification with indication of information on gratuitousness of load, producer, the manufacturing country, release form, quantity, expiration date;

2) the plan of target use (distribution) of the humanitarian assistance - the document approved by the head of the organization of health care, containing information on terms, the place, the name, the number of distribution of the humanitarian assistance;

3) authorized body in the field of health care (further - authorized body) - the central executive body performing management and cross-industry coordination in the field of protection of public health, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, control of quality of medical services;

4) proper production practice (GMP) - the standard in the field of health care establishing requirements to production organization, production process and monitoring procedure in case of production of medicines, medical products;

5) the registration file - the set of documents and materials of the established content represented together with the statement on state registration, re-registration of medicine, medical products and modification of the registration file.

Chapter 2. Procedure for import of medicines

4. For receipt of the conclusion (the allowing document) for import to the territory of the Republic of Kazakhstan of the medicines of person, the stipulated in Article 80-1 Code registered in the Republic of Kazakhstan (further - the applicant) represent on the web portal of "The electronic government" (further - the Portal) the following documents:

1) for humanitarian assistance (assistance):

statement;

the electronic copy of the written confirmation about control of target non-commercial use of medicines from local authorities of public administration by health care of the areas, cities of republican value and the capital or the organizations of health care having the license for medical activities, supporting this humanitarian action;

the electronic copy of the document confirming humanitarian character of load with transfer into the Kazakh or Russian languages;

electronic copy of the plan of target use (distribution) of the humanitarian assistance;

2) for prevention and (or) elimination of effects of emergency situations:

statement;

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

the electronic copy of the letter from local executive bodies on emergency situation (natural and technogenic nature).

Applications on import to the territory of the Republic of Kazakhstan of the medicines registered in the Republic of Kazakhstan are submitted on the Portal in form according to appendix 1 to these rules.

5. For receipt of the conclusion (the allowing document) for import to the territory of the Republic of Kazakhstan of the unregistered medicines in the Republic of Kazakhstan the applicant submits the following documents on the Portal:

1) for performing clinical trials:

statement;

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