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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, medical products and assessment of their safety and quality

(as amended of the Order of the Minister of Health of the Republic of Kazakhstan of 10.06.2019 No. KR DSM-93)

According to the subitem 122) 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" PRIKAZYVAYU:

1. Approve the enclosed 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.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development 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 after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction on official publication in periodic printing editions and information system of law of regulatory legal acts of the Republic of Kazakhstan of Ad_let;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan;

4) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of health and social development 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 vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

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

Minister of health and social development of the Republic of Kazakhstan

T. Duysenova

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) the contest 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 sphere 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 the contest committee and determines the secretary of the contest committee.

The decision on creation of the contest committee and determination of the secretary of the contest 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 the contest committee are the chairman, the vice-chairman and other members of the contest committee. During absence of the chairman of its function the deputy carries out. The total quantity of members of the contest committee constitutes odd number and at least five people.

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

15. Chairman of the contest committee:

1) plans work and directs activities of the contest committee;

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

18. The decision of the contest committee is made by open voting and deemed accepted if for it the majority of votes from total quantity of the members of the contest committee who are present at meeting is given. In case of equality of votes the decision for which the chairman of the contest committee or, in case of its absence, the vice-chairman voted is deemed accepted. In case of disagreement with the solution of the contest committee any member of this contest committee has the right to special opinion which is stated in writing and is applied to the minutes of the contest committee.

19. Organizational activities of the contest committee are provided with the secretary of the contest committee. The secretary of the contest committee is not member of the contest committee and has no right to vote in case of adoption of decisions by the contest committee.

The secretary of the contest committee is determined from among officials of structural division of the organizer (customer) of purchases responsible for the organization and carrying out purchases.

Secretary of the contest committee:

1) creates the agenda of meeting of the contest committee, provides the commission with necessary documents, will organize holding meeting of the contest committee;

Draws up 2) and signs the protocol of opening of envelopes with bids, the protocol on the admission to participation in tender, the protocol on tender results on purchase, and other protocols of meetings of the contest committee;

3) sends to the organizer (customer) of purchases the protocols of meetings signed by the contest committee;

4) ensures safety of documents and materials of purchases of goods and services from the moment of opening of bids;

5) performs registration of potential suppliers in the magazine.

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