ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of June 10, 2019 No. KR DSM-93

About introduction of amendments to the order of the Minister of health and social development of the Republic of Kazakhstan of June 26, 2015 No. 525 "About approval of Rules of purchase of goods and services for implementation of examination in case of state registration of medicines, products of medical appointment and assessment of their safety and quality"

According to the subitem 122) of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" I ORDER:

1. Of June 26, 2015 No. 525 "About approval of Rules of purchase of goods and services for implementation of examination in case of state registration of medicines, products of medical appointment and assessment of their safety and quality" (it is registered on July 29, 2015 No. 11783, is published in the Register of state registration of regulatory legal acts on August 25, 2015 in information system of law of Ad_let) to make the following changes to the order of the Minister of health and social development of the Republic of Kazakhstan:

state heading in the following edition:

"About approval of Rules of purchase of goods and services for implementation of examination in case of state registration of medicines, medical products and assessment of their safety and quality";

The rules of purchase of goods and services for implementation of examination in case of state registration of medicines, products of medical appointment and assessment of their safety and quality approved by the specified order to be reworded as follows according to appendix, to this order.

2. To "Committee of quality control and safety of goods and services" to provide the Ministries of Health of the Republic of Kazakhstan in the established legislative procedure to republican public institution:

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" the Ministries of Justice 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

to the Order of the Minister of Health of the Republic of Kazakhstan of June 10, 2019 No. KR DSM-93

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of June 26, 2015 No. 525

Rules of purchase of goods and services for implementation of examination in case of state registration of medicines, medical products and assessment of their safety and quality

Chapter 1. General provisions

1. These rules of purchase of goods and services in case of state registration of medicines, medical products and assessment of their safety and quality (further - Rules) are developed for implementation of examination according to the subitem 122) of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system".

2. The basic concepts used in these rules:

1) the potential supplier - the physical person performing business activity, the legal entity (except for public institutions if other is not established for them by the laws of the Republic of Kazakhstan), temporary consolidation legal entities (consortium), the purchase agreements applying for the conclusion;

2) the competitive price offer - the price offered by the potential supplier for participation in procurement by tender method, attached to the bid;

3) tender committee - the collegiate organ created by the organizer of purchases for accomplishment of the procedure of carrying out purchases by the tender method provided by these rules;

4) the tender documentation - documentation provided to the potential supplier for preparation of the bid which contains conditions and procedure for carrying out purchases by tender method;

5) service - the activities directed to satisfaction of need of the organizer (customer), which do not have material result;

6) residents of the Republic of Kazakhstan - the legal entities created according to the legislation of the Republic of Kazakhstan with the location on its territories, and also their branches and representations with the location in the Republic of Kazakhstan and beyond its limits;

7) the supplier - the physical person performing business activity, the legal entity (except for public institutions if other is not established by the laws of the Republic of Kazakhstan), the temporary consolidation legal entities (consortium) acting as the customer's partner in the purchase agreement signed with it;

8) commission of experts - the collegiate organ created by the organizer (customer) of purchases with involvement of experts for participation in development of the technical specification of the purchased goods, services and (or) preparation of the expert opinion concerning compliance of proposals of potential suppliers of the technical specification of the purchased goods, services;

9) the expert - the physical person having special and (or) technical knowledge, experience and qualification in the field of the carried-out public procurements, the confirmable relevant documents (diplomas, certificates, certificates and other documents), attracted by the organizer of public procurements or the customer to participation in development of the specification and (or) the technical specification of the purchased goods, works, services and (or) preparation of the expert opinion concerning compliance of proposals of potential suppliers of the technical specification of the purchased goods, works, services;

10) purchases - acquisition by the customer of goods and services, according to appendix 14 to these rules, necessary for implementation of examination in case of state registration of medicines, medical products and assessment of their safety and quality, performed according to the procedure, established by the civil legislation of the Republic of Kazakhstan and these rules, except for the purchase of goods and services performed according to international treaties of the Republic of Kazakhstan and also within implementation of the investment projects financed by the international organizations which member is the Republic of Kazakhstan, including with use of the web portal of purchases;

11) the web portal of purchases - the information system of the organizer (customer) providing single point of access to electronic procurement;

12) the purchase agreement - the civil agreement signed between the Customer and the supplier, including electronically by means of the web portal of purchases;

13) goods - subject (thing), including semifinished product or raw materials in strong, liquid or gaseous state, objektivirovanny results of creative intellectual activities, the corporeal rights, the equipment (the devices, devices and the equipment used separately in complexes or systems);

14) the organizer (customer) - the state expert organization in the field of drug circulation, medical products or its branch;

15) the digital signature - set of electronic digital symbols created by means of the digital signature and confirming reliability of the electronic document, its accessory and invariance of content;

3. These rules extend to the potential suppliers delivering and provide purchase of goods and services for implementation of examination in case of state registration of medicines, medical products and assessment of their safety and quality.

4. Implementation of purchases is based on the principles:

1) optimum and effective expenditure of the money used for purchases;

2) provisions to potential suppliers of equal opportunities for participation in the procedure of carrying out purchases;

3) fair competition among potential suppliers;

4) openness and transparency of process of purchases;

5) responsibility of participants of purchases;

6) non-admissions of corruption manifestations;

5. The procedure for purchases includes:

1) development and approval of procurement plan;

2) choice of the supplier;

3) conclusion and agreement performance about purchases.

Chapter 2. Procedure for development and approval of procurement plan of goods and services for implementation of examination in case of state registration of medicines, medical products and assessment of their safety and quality

6. The annual plan of purchases is developed and affirms the organizer (customer) based on the development plan.

7. The annual plan of purchases affirms the organizer (customer) within ten working days from the date of approval of the development plan.

8. The organizer (customer) within five working days from the date of approval of the annual plan of purchases places it on Internet resource and the web portal of purchases.

9. The annual plan of purchases is signed by the first head of the organizer (customer) or replacement his face.

10. The organizer (customer) makes changes and (or) additions to the annual plan of purchases no more than two times a month.

11. The organizer (customer) within five working days from the date of decision making about modification and (or) amendments in the annual plan of purchases places the made changes and (or) additions on Internet resource and the web portal of purchases.

Chapter 3. Procedure of purchase of goods and services for implementation of examination in case of state registration of medicines, medical products and assessment of their safety and quality

12. The purchase is performed by the following methods:

1) tender on selection of the supplier on qualification requirements and technical characteristics;

2) tender on selection of the supplier on qualification requirements and technical characteristics by means of the web portal of purchases.

3) request of price offers;

4) from one source.

The purchase provided by subitems 2) - 4) this Item, the organizer (customer) of purchase conducts procurements, in electronic form by means of the web portal. In case of not operability of the web portal of purchases more than 5 (five) working days or lack of access at the organizer (customer) of purchase to functionality of the web portal of purchases the purchase is performed in paper form.

13. The customer determines method of implementation of purchases proceeding from annual amounts of the goods and services necessary for ensuring activities of the customer:

1) tender on selection of the supplier on qualification requirements and technical characteristics) - if the annual purchasing amount of certain goods, or certain service in value term exceeds seven thousandfold size of the monthly settlement indicator established by the law on the republican budget for the corresponding financial year;

2) request of price offers - if the annual purchasing amount of certain goods, or certain service in value term does not exceed seven thousandfold size of the monthly settlement indicator established by the law on the republican budget for the corresponding financial year;

3) from one source in the cases provided by Items 90 and 91 of these rules;

Paragraph 1. Tender on selection of the supplier on qualification requirements and technical characteristics

14. For performing procedures of carrying out purchase of goods and services the organizer (customer) of purchases on carrying out each purchase separately creates tender committee and determines the secretary of tender committee.

The decision on creation of tender committee and determination of the secretary of tender committee is accepted by the first head of the organizer (customer) or person fulfilling its duties and is drawn up in the form of the order.

Members of tender committee are the chairman, the vice-chairman and other members of tender committee. During absence of the chairman of its function the deputy carries out. The total quantity of members of tender committee constitutes odd number and at least five people.

The chairman of tender committee is determined by the first head of the organizer (customer).

15. Chairman of tender committee:

1) plans work and directs activities of tender committee;

2) presides over meetings of tender committee;

3) performs other functions provided by these rules.

16. The commission is effective from the date of entry into force of the decision on its creation and stops the activities from the date of the conclusion of the purchase agreement of goods and services.

17. Meetings of tender committee are held on condition of presence of simple majority of total number of members of tender committee and drawn up by the protocol which is signed by the present members of tender committee and the secretary of tender committee. In case of absence of any member of tender committee in the minutes of tender committee the reason of its absence with appendix of the document confirming this fact is specified.

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