Order of the Minister of Health No 4/2019

Bratislava 17. April 2019
Number: S07990-2019-OPZ

Order of the Minister of Health of the Slovak Republic

No 4/2019

To increase transparency, ensure effective spending on the procurement of goods and works; and services, as well as checks in the award processes carried out in Public procurement Law No 343/2015 Z. z. o. public procurement and amending certain laws, as amended subsequent legislation (hereinafter referred to as the Public Procurement Act)

I command

1. Stock companies owned by the Ministry Healthy SR, member of statutory bodies of these companies

1. By 31 October of the relevant calendar year, submit to the Ministry Health of the Slovak Republic for the assessment of the plan of investment and sale of assets the following calendar year (within the meaning of Annex 1a to this Order).

• When declaring or initiating a procurement procedure to be received a decision within the meaning of a valid investment and sale plan', which was drawn up in accordance with the statutes of the public limited liability company the calendar year and approved by the General Assembly. Items included in the investment and sale plans under consideration' are not subject to specific the assessment process referred to in point (3). (a) this order, with the exception of Medical techniques to be followed establishing a paragraph 3 letter (b) this order and subsequently request consent Ministry of Health of the Slovak Republic with the beginning of the implementation of the public process procurement in accordance with the provision (s). 3 letter (a) this Order. In case of all other items (i.e. medical equipment up to EUR 30 000.00) without VAT) however, it is necessary before the implementation of public for assessment completed by the Ministry of Health of the Slovak Republic tables within the meaning of Annex 3 to this order by electronic means to: procurement@health.gov.sk If the Ministry of Health SR under 10 calendar days after their delivery does not express the implementation of the relevant public procurement may be launched. To be sentThe Ministry of Health of the Slovak Republic information about the beginning of the relevant public procurement (referred to in Annex No. 4 this order) and up to two working days after the end of the calendar month in which it was applicable Public procurement implemented, sent to the Ministry of Health of the Slovak Republic an indication of its implementation (within the meaning of Annex 5 to this Order).
• To award contracts for contracts not included in the plan investments and sales of assets" in case of unforeseen events; and emergency situations or other contracts which, by their nature, are not it is possible to include in the investment and sale plan of property (e.g. medicines, special medical materials, services, etc.) as follows:
• if the estimated value of the contract is equal to or greater than 15 000,00 Euro, VAT excluded, permission from the Ministry of Health initiating the public procurement process in accordance with the provision paragraph 3 (a) a) this order; request the approval of the Ministry of Health Slovakia with the start of the performance of the contract in question is also necessary Exemptions Act on public procurement within the meaning of Article 1 (except § 1 (14)) Act public procurement;
• for a contract with an estimated value of less than EUR 15 000.00 excluding VAT, may be effected by decision of the statutory authority companies, but to be sent to the Ministry of Health of the Slovak Republic Information on the opening of the relevant public procurement procedure (referred to in Annex No. 4 this order) and within two working days after the end of the calendar month, where the relevant procurement was carried out, send Information to the Ministry of Health about its implementation (in terms of Annex 5 to this Order). In case the contract was previous sentences implemented by direct order, without use procedures under the Public Procurement Act, to be sent information on the issue of the order (as set out in Annex No. 4a of this Order).
• If the estimated value of the contract is higher than the approved value By the General Assembly in the "Plan of investment and sale of assets', which was drawn up in accordance with the statutes of the public limited liability company on the relevant calendar year, the approval of the Ministry of Health of the Slovak Republic is required starting the implementation of the public procurement process for the new foreseen the value of the subject matter of the contract, together with the justification for its increase, i.e. to submit The Ministry of Health of the Slovak Republic duly requested in accordance with the provision (1). 3 letter (a) this Order.

2. State contribution organisations and state budget organizations within the scope of the Ministry of Health of the Slovak Republic, the statutory bodies of these organisations.

1. By 31 October of the relevant calendar year, submit to the Ministry Health of the Slovak Republic for the assessment of the plan of procurement of goods and works; and services of the following calendar year approved by the statutory authority the organisation concerned (referred to in Annex No. 1b of this Order).
2. When declaring or initiating a procurement procedure to be received decisions within the meaning of the submitted proposal for the procurement of goods, works and services-approved by the statutory authority of the organisation concerned.

• If the estimated value of the contract is equal to or greater than 15 000,00 Euro, VAT excluded, to be requested before public procurement agreement of the Ministry of Health of the Slovak Republic to start the implementation of the public process procurement in accordance with the provision (s). 3 letter (a) that order, including in where the contract concerned has been included in the "Procurement plan', construction works and services. Request permission from the Ministry of Health of the Slovak Republic the start of the performance of the contract in question is also necessary in case of exceptions from Act on public procurement within the meaning of § 1 (except § 1 (14) Act public procurement;
• The award or opening of a contract award; whose estimated value is less than EUR 15 000,00 excluding VAT, to implement by decision of the statutory authority and with an obligation to send Information to the Ministry of Health about the start of the process public procurement (referred to in Annex No. 4 executions (within the meaning of Annex 5 to this order). In case of contract according to the previous sentence carried out by direct order, without using procedures under the Public Procurement Act, send information on the issue of the order (as set out in Annex No. 4a this the order).
• In the case of the execution of a public procurement contract which was not included in the "Procurement plan for goods, works and services' of which the estimated value is equal to or greater than

15 000.00 Euro, VAT excluded, no need to request the Ministry of Health of Slovakia supplementing the "Procurement plan for goods, works and services'. In this If appropriate, request for consent to commence the implementation of the public procurement process in accordance with the provision (s). 3 letter (a) this Order.

3. Stock companies owned by the Ministry Health, state contribution organizations and state budget organizations within the scope of the Ministry of Health of the Slovak Republic, the statutory authority and the members of the statutory bodies of those companies; and organisations.

1. When requesting approval of the Ministry of Health of the Slovak Republic implementation of the process of public procurement of goods, works and services the following rules shall be followed:

• Request to send in form with defined minimum requirements according to the model set out in Annex No. 2 the name of the subject-matter of the contract must be established accurately and unambiguously already in time; submitting a request for consent to start the process public procurement to avoid confusion in terms of classification contracts to the relevant CPV category (s) and all the time the execution of a public procurement procedure using this single title;
• the application must be clearly marked on the cover by the term "Procurement',
• the annexes to the application must be:

i. description of the subject-matter of the contract (in case of award without use of the contract) an electronic marketplace) or a descriptive form of the subject matter of the contract, which went through the quarantine of the electronic marketplace or was selected from the library existing descriptive forms (in case of award using e-market), if applicable, pre-accepted offer selected from the catalogue of offers,
ii. Information on how to calculate the estimated contract value in accordance with s § 6 of the Public Procurement Act; if it was the basis for the calculation the estimated value of the contract market research must be annexed to the calculation,
(iii) procurement documents, including draft contract (in case of award) over- and under-limit contracts without using an electronic marketplace; over-the-counter contracts using the e-market area, the procedure under § 66 paragraph 8 of the Public Procurement Act and, in the case of public procurement, Sub-limitary concessions), where the tender documents are sufficient to be sent by electronic means form to: procurement@health.gov.sk,
iv. for public procurement of medical equipment to also provide a return on investment or contract by health insurance companies,
v. an opinion issued in accordance with the methodology set out in Annex 9 of this an order for the procurement of the medical equipment in question;
vi. in the case of public procurement of medicinal products, it is also necessary to submit a table within the meaning of Annex 6 to this Order,
vii. in the case of public procurement of medical material, a table must also be provided within the meaning of Annex 7 to that order.

1. in the case of special medical material, define the terms and conditions of the contracting authority so as to enable them to submit an offer to several potential suppliers; to this end, Definition of part –Description of the subject matter of the contract required be based on the current breakdown of groups and sub-groups of special medical material as specified in the current list categorised special medical materials which it publishes Ministry of Health and always in the current version accessible at: http://www.health.gov.sk/?zkszm; where the contracting authority considers it necessary to use More detailed technical specification of the subject matter of the contract in addition to the breakdown groups and subgroups of special medical material, such as: the procedure to justify in writing the application;
2. for recurring tenders for the same subject-matter of the contract − if the estimated value of one contract individually awarded is lower as EUR 15 000.00 excluding VAT, but the total estimated value of these contracts (for the same subject-matter of the contract) exceed EUR 15 000.00, VAT excluded for a certain period of time (e.g. 12 months), consent should be sought Ministry of Health of the Slovak Republic with the beginning of the implementation of the public process procurement to total value over the required period (e.g.: 12 months) and method of gradual implementation over the relevant period specify in the request for consent to start the implementation of the public procedure procurement (referred to in Annex No. 2 of this order), also in information on launching a public procurement procedure (referred to in Annex 4 of this the order) as well as an overview of its implementation (within the meaning of Annex 5 to this order); if there is an urgent need during the calendar year to carry out public procurement on the same subject-matter of the contract as it was realized, with the value of one contract individually awarded being lower as EUR 15 000.00 excluding VAT, but the total estimated value of these contracts (for the same subject matter of the contract) exceed 15 000,00 EUR, VAT excluded in for 12 months, the approval of the Ministry is required health and for a contract with a value of less than EUR 15 000.00 without VAT,

• when awarding a conditional contract using an electronic marketplace According to § 109-111 of the Public Procurement Act, it is necessary in electronic the contract system (ECS) indicating the maximum amount of funding; available to the contracting authority to finance the subject-matter of the contract.
• When requesting approval of the Ministry of Health of the Slovak Republic implementation of the public procurement process for medical goods technique and for which there is a high probability that assumed the value of the contract shall be equal to or greater than: EUR 30 000.00, VAT excluded, the following shall be complied with in addition to the obligations referred to in this paragraph: rules:
• Before carrying out market research, the Ministry should be sent Slovak Health electronically to: Medical technician@health.gov.skthe specification of the medical technique in question in accordance with the methodology described above Annex 9 of this Order;
• opinion issued in accordance with the methodology set out above as set out in the Annex No 9 of this order to acquire the medical equipment in question is also Mandatory annex to the request for consent to start implementation the public procurement process; 3. Ministry of Health of the Slovak Republic based on the sent specification process the average price of the medical technique in question and up to seven forward its opinion to the applicant on working days. Recommended use of this the opinion of the Ministry of Health of the Slovak Republic is described in Annex 9 of this order,
• in the case of the procurement of medical equipment through EKS, necessary on the descriptive form, within its part performance of the contract submit a detailed updated budget for the subject matter of the contract. Ask agreement of the Ministry of Health of the Slovak Republic to start the implementation of the public process procurement is also necessary for the execution of public procurement through the central purchasing body (s) joint procurement of goods, works and services,
• In the process of any procurement with estimated value contracts above 70 000,00 EUR, VAT excluded (except for standard contracts with Using the electronic market market place, the procedure under § 66 (8) of the Law on public procurement, conditional contracts using electronic means the market place, the procedure under § 109-111 of the Public Procurement Act; and low-value contracts Procurement) to invite a member of the commission to open tenders State employee of the Ministry of Health of the Slovak Republic medical technicians, including those with high standards contracts carried out by a tender procedure pursuant to § 66 (7) of the Law on public procurement (reverse competition). Application for nomination of a member a representative of the Ministry of Health of the Slovak Republic to the Commission for opening of offers within public procurement to be sent to the Ministry of Health of the Slovak Republic at least 10 calendar days before the date of the commission meeting.
• The relevant procurement needs to be declared in the envisaged value for which approval of the Ministry of Health of the Slovak Republic has been granted start implementation; if the estimated value is increased, or a substantial change in the subject matter of the contract before the start of the public execution procurement, it is necessary to submit to the Ministry of Health of the Slovak Republic a new Request for consent to start the public process the procurement, together with a justification for the change in the estimated value, or the subject of the contract, the original application being cancelled. In others cases (reduction of the estimated value of the contract, minor change subject matter of the contract and so on) does not need to be submitted to the Ministry Slovakia new request for consent to start implementation the public procurement process, but in this case it is necessary to send Information about such change to the Ministry of Health of the Slovak Republic electronically Address: procurement@health.gov.sk a wait for the opinion of the Ministry of Health of the Slovak Republic on this change. Start The relevant public procurement process is only possible after agreement mentioned change by the Ministry of Health of the Slovak Republic (electronically).
• If the value during the procurement process or after the electronic auction is higher than the estimated value of the contract; to which approval of the Ministry of Health of the Slovak Republic was granted to the Ministry of Health of the Slovak Republic immediately Package leaflet: before concluding a contract with a successful candidates.
• Use electronic auction in accordance with the relevant provisions of the Act public procurement.
• Only award contracts resulting from public procurement with applicants/suppliers who have a valid entry in the Register Public Sector Partners (public sector partners) 315/2016 Coll. on the Register of Public Sector Partners and amending certain legislation which entered into force on 1 February 2017.
• In order to increase transparency on purchases and use public sector information and communication technologies procurement as follows:
• when concluding all types of contracts, including framework agreements for purchases Information and communication technologies as well as other protective works intellectual property, with the exception of, in commercial practice known as so-called provisions for the grant of a licence within the meaning of the material listed in Annex 8 that order,
• when concluding contracts, including framework purchase agreements include information and communication technologies as a standard in contracts, including Framework agreements provisions on publication of authors, manufacturers and subcontractors the contractor within the meaning of the material listed in Annex 8 to this Order,
• in the case of contracts including framework agreements for purchases Information and communication technologies as well as other protective works intellectual property, with the exception of package software, copyright to proceed within the meaning of the material listed in Annex 8 to this order,
• publish on its website the reasons for cases where the rules referred to in points 1 to 3 of this point cannot be complied with,
• for each project (public procurement) information systems above 1 EUR million excluding VAT to be drawn up as a mandatory part of the project (documentation of Public procurement) procedural clause in terms of project standards management and submit to the Ministry of Health of the Slovak Republic deduction of this Tasks by 15 November of the calendar year concerned to the Secretary-General a service office,
• The question referred to above is governed by the provision of a Methodological instruction for standard terms of reference contracts, standard conditions for participation and optimal contract conditions related to ICT projects prepared by the Ministry of Finance of the Slovak Republic and made available in the current version at:http://www.informatizacia.sk/public-procurement-and-contract-pre-ikt/15273s.
• To have an established profile of the contracting authority within the meaning of the relevant the provisions of the Public Procurement Act and publish them all information and documents provided for in the Public Law procurement, in a manner determined by the Public Procurement Office. To publish on its website all contracts resulting from the public procurement process.
• Weeklylyly send to the Ministry of Health SR information about the launch the execution of any procurement for all contracts with the estimated value of the same or more than EUR 5 000 excluding VAT, including for contracts with an estimated value equal to or greater than 15 EUR 000,00 excluding VAT, for the start of implementation of which consent was granted Ministry of Health (according to Annex No. 4 of this Order). Beginning public procurement means publication of a notice of declaration Public procurement or calls for tenders in the Journal public procurement or the award of a contract in an electronic marketplace, or the dispatch of a call for award pursuant to Paragraph 117 of the Law on public procurement. Within two working days following the end of the calendar the month in which the procurement concerned was carried out, to be sent Ministry of Health SR overview of realized public procurement for all contracts with an estimated value equal to or greater than 5 EUR 000,00 excluding VAT as defined in Annex 5 to this order. Weekly information on the opening of public procurement and monthly overviews public procurement is also to be sent if in the relevant week (s) and month (s) have not started or completed any public procurement.
• Weeklylyly send to the Ministry of Health SR information about exposure each order (within the meaning of Annex 4a, to: procurement@health.gov.sk, and also for the Ministry's Management Office Health SR, Department of Evaluation of Processes in subordinates organisations Address: ovppo@health.gov.sk. This concerns direct orders placed by the out-of-law regime, in the amount up to EUR 5 000.00, VAT excluded or as determined by the Public Law procurement.
• Strictly comply with the provisions of the Public Procurement Act; and actively cooperate and comply with the Ministry's orders and related instructions Health of the Slovak Republic in the implementation of all process related tasks procurement of goods, works and services. Among the related instructions In particular, the order of the Minister of Health No 3/2016 of 7 June 2016 and Order No 7/2017 of the Minister for Health of the Slovak Republic of 25 September 2017 including related supplements.
• Written communication (plans, requests for consent to start) implementation of the public procurement process, applications for nomination of a member to Committees for opening tenders, justification for increasing the estimated value contracts, etc.) to be sent by post to the Procurement Department. Tables to be completed in accordance with the annexes to this order are necessary send also by e-mail in Excel format, to: procurement@health.gov.sk, where the prescribed content or form of the tables cannot be changed; and adapt. Information on the start of public procurement (v pursuant to Annex 4 to this Order) and an overview of all implemented Public procurement (referred to in Annex No. 5 this order) is sufficient to be sent electronically. IInformation on the issue of orders (within the meaning of Annex 4a to this Order) it is necessary to send to Address: procurement@health.gov.sk, and also for the Ministry's Management Office Health SR, Department of Evaluation of Processes in subordinates organisations Address:ovppo@health.gov.sk. Specification of the medical technique in question in accordance with the methodology described above Annex 9 of this Order before carrying out a market survey is necessary send the Ministry of Health to: Medical technicians@health.gov.sk
• All documents sent electronically, i.e. plans, applications, information, surveys, procurement documents is to be sent separately with a clear indication of the subject e-mail.
• In case of unforeseen events and emergency situations, the acceleration of the procedure can be used by electronic means, but subsequently the application it must also be sent by post. There must be a compelling reason for the accelerated procedure: provision cannot be used in cases where the contracting authority could prevent early submission of a request for consent to commence implementation of the public procurement process (see the following provision).
• Requests for consent to start the public process Procurement must be sent in good time before the actual start of the execution of the public procurement or the expiry of the period the validity of the contract so that the Public Procurement Commission has sufficient the scope for their assessment and discussion and for all to be observed; the time limits resulting from the Public Procurement Act.
• Applications to be submitted on header paper, signed by the statutory authority, including, where appropriate, an amendment to the applications; which are sent only by electronic means, in which case it is necessary to support the signed document in its scanned form (excluding tables in Excel format to be sent for medicinal products and medical devices, in the signed document is not required in the scanned form). V the application for the procurement of medical equipment, medicinal products, and special and consumables medical material is necessary complete a request with all annexes to be sent by electronic means to: procurement@health.gov.sk.
• Where a tender is submitted by only one tenderer and the value specify in the tender, is higher than expected, to be applied Provisions § 57 (2) of the Public Procurement Act.
• In the case of over- and under-limit contracts without recourse e-marketplace, as well as for over-the-counter contracts e-market and, in the case of over- and under-limit concessions before the actual signature of the contract with the tenderer whose tender was evaluated as successful, submit to the Ministry of Health of the Slovak Republic Approval of material - Proposal for approval of the conclusion of a contract (Annex No. 10 of the order), including the final version of the contract. This provision concerns only tendering procedures for the award of contracts, i.e. not applicable a direct negotiated procedure or, in the case of low value contracts, awarded by the procedure under § 117 of the Act on public procurement.
• In case of modification of a contract, framework agreement or concession contract during its duration without a new public procurement procedure (so-called "additionality') (e.g. the provisions of the Law on public procurement; and Request the approval of the Ministry Health of the Slovak Republic for any change of contract regardless of the value of change provided that this change increases the value of the original contracts. In this case, a completed application according to the Annex must be submitted No 2a of that order, the original contract which is the subject of the amendment and the draft amendment contracts. That provision concerns all amendments to contracts, irrespective of the procedure used in public procurement, i.e. those concluded the procedure under § 117 of the Public Procurement Act, provided that: The Ministry of Health of the Slovak Republic has given its consent to start their implementation (with original estimated contract value equal to or greater than 15 EUR 000.00, VAT excluded). In the case of contracts for which implementation by the Ministry Health SR did not grant consent (with original assumed value contracts up to 15 000.00 EUR, VAT excluded), the request for consent to change the contract during its duration it does not submit to the Ministry of Health. Listed the provision does not apply where the contract is subject to a reduction in value of the contract or change of the contract for reasons other than change its values (e.g.: change in compliance time, change in distribution points, change in places of implementation, change of subcontractor, etc.)
• This Order does not apply to the procurement of goods, works and services co-financed by the European Structural and Investment Funds.

4. Saving

1. To all statutory bodies and members of statutory bodies, ensure that everyone is aware of their competence in a demonstrable manner employees of the organisational units of public limited liability companies whose shareholders is the Ministry of Health of the Slovak Republic, employees of state budget and contributory organisations in the Ministry's founding competence Slovak Health with the above command/decision on the day of its acquisition efficacy.
2. All heads of staff of the Ministry's organisational units in order to ensure awareness within the scope of its remit all employees in the relevant departments of the Ministry health care in Slovakia with the above command on the date of its entry into force.

In relation to employees of the Ministry of Health of the Slovak Republic breach of this order considered to be a serious breach of labour discipline.

5. Final provisions

1. This Order shall enter into force on 17 April 2019. Acquisition Day the effectiveness of this order is cancelled Order No 2/2017 of the Minister of Health of the Slovak Republic, which entered into force on 1 June 2017.
2. Where some provisions of this Order/Decision are they become invalid, ineffective or not for any reason; neither will it result in nullity, ineffectiveness, or failure to enforce the other provisions of the order. Until replacement of an invalid, ineffective or unenforceable provision of the order new, but also in the absence of any replacement, Replacing an invalid, ineffective or irrecoverable provision other provisions of the order and, if they are not, the relevant provisions existing legislation.

Andrea Kalavská
Minister