Supply, Delivery and Installation of Laboratory Equipment for the Radiopharmaceutical Production of the PET (Positron Emission Tomography) Centre — Skopje

Ministry of Health

Supply, Delivery and Installation of Laboratory Equipment for the Radiopharmaceutical Production of the PET (Positron Emission Tomography) Centre — Skopje.

Рок

Рокот за прием на понудите беше 2014-09-30. Набавката беше објавена на 2014-09-12.

Кој? Што? Каде?
Историја на набавките
Датум Документ
2014-09-12 Оглас за договор
Оглас за договор (2014-09-12)
Предмет
Опсег на набавката
Наслов: Medical equipments, pharmaceuticals and personal care products
Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Медицинска опрема, фармацевтски производи и производи за лична нега 📦

Постапка
Вид на постапка: Отворена постапка
Вид на понуда: Поднесување за еден или повеќе делови
Критериуми за доделување
Најниска цена

Договорен орган
Идентитет
Земја: Северна Македонија 🇲🇰
Вид на органот кој доделува: Министерство или кој било друг национален или федерален орган
Име на органот кој доделува: Ministry of Health
Поштенска адреса: 50 divizija No 6
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: http://www.moh.gov.mk 🌏
Е-пошта: emilija.belopeta@zdravstvo.gov.mk 📧
Телефон: +389 23129006 📞
Факс: +389 23176042 📠

Референца
Датуми
Датум на испраќање: 2014-09-12 📅
Рок за поднесување: 2014-09-30 📅
Датум на објавување: 2014-09-17 📅
Идентификатори
Број на огласот: 2014/S 178-315471
OJ-S издание: 178

Предмет
Опсег на набавката
Краток опис:
Supply, Delivery and Installation of Laboratory Equipment for the Radiopharmaceutical Production of the PET (Positron Emission Tomography) Centre — Skopje.
Број на дел: 1
Наслов на делот: Lot 1
Краток опис:
Supply, delivery and installation of Laboratory Equipment (heavy build in equipment) for the 18F-FDG Production Laboratory — 00.02.02 of the Positron Emission Tomography PET Centre — Skopje, all in accordance with the technical specifications.
Дополнителни информации за деловите:
1.0 LOT 1Supply, delivery and installation of Laboratory Equipment (heavy build in equipment) for the 18F-FDG Production Laboratory — 00.02.02 of the Positron Emission Tomography PET Centre — Skopje, all in accordance with the technical specificationsNo.DescriptionQty Model / typeManufacturer / country of origin Price without VAT with included expenses and discounts VAT Total price(Qty*Price without VAT)1.1. Double stack hot cellFor synthesis modules 11.2. Dispensing isolator including autocalve and vials and syringuesDispenser 11.3Disepenser for vials and syringes 11.4 Laminar flow hood11.5 Radiopharmaceutical synthesizer 21.6 Switching delivery system for radionuclides from cyclotron to hot cells 1Total Lot 1
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1.0 LOT 1
Supply, delivery and installation of Laboratory Equipment (heavy build in equipment) for the 18F-FDG Production Laboratory — 00.02.02 of the Positron Emission Tomography PET Centre — Skopje, all in accordance with the technical specifications
No.
Description
Qty Model / type
Manufacturer / country of origin Price without VAT with included expenses and discounts VAT Total price
(Qty*Price without VAT)
1.1. Double stack hot cell
For synthesis modules 1
1.2. Dispensing isolator including autocalve and vials and syringues
Dispenser 1
1.3
Disepenser for vials and syringes 1
1.4 Laminar flow hood
1
1.5 Radiopharmaceutical synthesizer 2
1.6 Switching delivery system for radionuclides from cyclotron to hot cells 1
Total Lot 1
Број на дел: 2
Наслов на делот: Lot 2
Краток опис:
Supply, delivery and installation of Laboratory Equipment (heavy build in equipment) for the PET Radiopharm. Production Lab. — 00.02.03 of the Positron Emission Tomography PET Centre — Skopje, all in accordance with the technical specifications.
Дополнителни информации за деловите:
2.0 Lot 2Supply, delivery and installation of Laboratory Equipment (heavy build in equipment) for the PET Radiopharm. Production Lab. — 00.02.03 of the Positron Emission Tomography PET Centre – Skopje, all in accordance with the technical specificationsNo.DescriptionQty Model / typeManufacturer / country of origin Price without VAT with included expenses and discounts VAT Total price(Qty*Price without VAT)2.1 Shielded synthesis hot cell for housing for 11C synthesis module12.2 Shielded synthesis hot cell for housing for 68Ga synthesis module12.3 Ga-68 Radiopharmaceutical synthesizer 12.4 C-11 Radiopharmaceutical synthesizer 1Total Lot 2
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2.0 Lot 2
Supply, delivery and installation of Laboratory Equipment (heavy build in equipment) for the PET Radiopharm. Production Lab. — 00.02.03 of the Positron Emission Tomography PET Centre – Skopje, all in accordance with the technical specifications
2.1 Shielded synthesis hot cell for housing for 11C synthesis module
2.2 Shielded synthesis hot cell for housing for 68Ga synthesis module
2.3 Ga-68 Radiopharmaceutical synthesizer 1
2.4 C-11 Radiopharmaceutical synthesizer 1
Total Lot 2
Број на дел: 3
Наслов на делот: Lot 3
Краток опис:
Supply, delivery and installation of Laboratory Equipment (heavy build in equipment) for the Therapy Research Lab. — 00.02.04 of the Positron Emission Tomography PET Centre — Skopje, all in accordance with the technical specifications.
Дополнителни информации за деловите:
3.0 Lot 3Supply, delivery and installation of Laboratory Equipment (heavy build in equipment) for the Therapy Research Lab. — 00.02.04 of the Positron Emission Tomography PET Centre — Skopje, all in accordance with the technical specifications.No.DescriptionQty Model / typeManufacturer / country of origin Price without VAT with included expenses and discounts VAT Total price(Qty*Price without VAT)3.1 Hot cell for radiotherapy 13.2 GMP hot cell forRadiotherapy 13.3 Laminar flow hood 1Total Lot 3
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3.0 Lot 3
Supply, delivery and installation of Laboratory Equipment (heavy build in equipment) for the Therapy Research Lab. — 00.02.04 of the Positron Emission Tomography PET Centre — Skopje, all in accordance with the technical specifications.
3.1 Hot cell for radiotherapy 1
3.2 GMP hot cell for
Radiotherapy 1
3.3 Laminar flow hood 1
Total Lot 3
Број на дел: 4
Наслов на делот: Lot 4
Краток опис:
Supply, delivery and installation of Radiation Protection Equipment (built in equipment) for the facility for Positron Emission Tomography — PET Centre Skopje, all in accordance with the technical specifications.
Дополнителни информации за деловите:
4.0 Lot 4Supply, delivery and installation of Radiation Protection Equipment (built in equipment) for the facility for Positron Emission Tomography — PET Centre Skopje, all in accordance with the technical specifications.No.DescriptionQty Model / typeManufacturer / country of origin Price without VAT with included expenses and discounts VAT Total price(Qty*Price without VAT)4.1 Cyclotron bunker gamma dose rate meter 14.2 Cyclotron bunker air contamination sampler 14.3 Fixed gamma dose rate unit in the technical room 14.4 Target maintenance workbench 14.5 Area dose rate meters74.6 Central area dose rate monitoring and recording system 14.7 Air contamination monitor sampling system 14.8 Air compression station14.9 Target safe cabinet14.10 Bunker motion detector14. 11 General stack monitor14. 12 Liquid radioactivity automatic sampling system for the liquid waste reservoir — 01.02.07 1Total Lot 4
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4.0 Lot 4
Supply, delivery and installation of Radiation Protection Equipment (built in equipment) for the facility for Positron Emission Tomography — PET Centre Skopje, all in accordance with the technical specifications.
4.1 Cyclotron bunker gamma dose rate meter 1
4.2 Cyclotron bunker air contamination sampler 1
4.3 Fixed gamma dose rate unit in the technical room 1
4.4 Target maintenance workbench 1
4.5 Area dose rate meters
7
4.6 Central area dose rate monitoring and recording system 1
4.7 Air contamination monitor sampling system 1
4.8 Air compression station
4.9 Target safe cabinet
4.10 Bunker motion detector
4. 11 General stack monitor
4. 12 Liquid radioactivity automatic sampling system for the liquid waste reservoir — 01.02.07 1
Total Lot 4
Број на дел: 5
Наслов на делот: Lot 5
Краток опис:
Supply, delivery and installation of Equipment for Quality Control Laboratories of the Positron Emission Tomography – PET Centre Skopje, all in accordance with the technical specifications.
Дополнителни информации за деловите:
5.0 Lot 5Supply, delivery and installation of Equipment for Quality Control Laboratories of the Positron Emission Tomography — PET Centre Skopje, all in accordance with the technical specifications.No.DescriptionQty Model / typeManufacturer / country of origin Price without VAT with included expenses and discounts VAT Total price(Qty*Price without VAT)5.1 Shielded Laminar Flow Hood For Quality Control2Total Lot 5
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5.0 Lot 5
Supply, delivery and installation of Equipment for Quality Control Laboratories of the Positron Emission Tomography — PET Centre Skopje, all in accordance with the technical specifications.
5.1 Shielded Laminar Flow Hood For Quality Control
2
Total Lot 5
Референтен број: 30/2014
Место на извршување
Главна локација или место на извршување: Facility for Positron Emission Tomography, PET Centre Skopje.

Правни, економски, финансиски и технички информации
Услови за учество
Способност за вршење на стручната дејност:
2.2.1 The Contracting authority shall exclude any economic operator from the procedure for awarding a public procurement contract if:
— an effective court decision for participation in criminal organization, corruption, fraud or money laundering was rendered in the past 5 years;
— a minor penalty – ban on participation in public call procedures, awarding public procurement contracts and contracts on public-private partnership has been pronounced;
— a minor penalty – temporary or permanent interdiction to carry out particular business activity has been pronounced;
— the economic operator is in bankruptcy or liquidation procedure;
— the economic operator has unsettled taxes, contributions and other public duties, with the exception of cases in which the economic operator has been granted deferred payment of taxes, contributions or other public duties in accordance with the respective regulations;
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— a misdemeanour sanction has been pronounced – ban on performance of profession, action or responsibility, i.e. temporary ban on the performance of particular action; and
— the economic operator has given false data or has failed to submit the data requested by the Contracting Authority.
2.2.2 For the purpose of proving its personal status the economic operator shall submit the following documents:
— statement from the economic operator that no effective court decision for participation in criminal organization, corruption, fraud or money laundering was rendered in the past 5 years;
— statement by the competent authority that no
bankruptcy procedure has been initiated;
liquidation procedure has been initiated;
— receipt on settled taxes, contributions and other public duties by the competent authority from the country where the economic operator is registered;
— statement from the Register of penalties for crimes committed by legal persons stating that no minor penalty — temporary or permanent
ban has been pronounced for participation in invitation to tender procedures, awarding of a public procurement contracts or private-public partnership contract;
interdiction on carrying out particular business activity has been pronounced;
— statement that no misdemeanour sanction — interdiction on carrying out profession, action or responsibility, i.e. temporary interdiction on carrying out particular business activity, has been pronounced with an effective court decision.
2.2.3 The statement from indent 1, sub item 2.2.2 shall be prepared and signed by the economic operator, and it will not require verification by a competent authority.
2.2.4 The statements stating that no bankruptcy and liquidation procedure has been initiated, as well as the statements from the Register of penalties for criminal acts committed by legal persons of indents 5 and 6, sub item 2.2.2 shall be issued by the competent authorities in the country in which the economic operator has been registered. In the Republic of Macedonia the competent authority for issuance of the aforesaid statements is the Central Register of the Republic of Macedonia.
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2.2.5 The certificate of settled taxes, contributions and other public duties shall be issued by the competent authority from the country in which the economic operator has been registered. In the Republic of Macedonia the competent authority for issuance of the aforesaid receipt is the Public Revenue Office.
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2.2.6 The statement of indent 7, sub item 2.2.2 shall be issued by the competent authority in the country in which the economic operator has been registered. In the Republic of Macedonia the competent authority for issuance of the aforesaid statement is the Central Register of the Republic of Macedonia.
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2.2.7 The documents of sub item 2.2.2 shall not be older than 6 months calculated from the final deadline for submission of the tenders calculated backwards.
The Committee shall accept documents for establishing the personal status issued after the day of public opening of the bids, but not later than the day of adopting the decision for selecting most favourable tenderer.
2.2.8 If the country in which the economic operator has been registered, does not issue the documents specified in sub item 2.2.2 or if they do not encompass all aforementioned cases, the economic operator can submit a statement verified by the competent authority.
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Економска и финансиска состојба:
2.4.1 In order to qualify as competent for execution of the respective public procurement contract from aspect of economic and financial status, the economic operator shall meet the following minimum requirements:
a minimum total turnover of at least 650 000 EUR for the last 3 years (2011, 2012 and 2013) for Lot 1, Lot 2 and Lot 3;
a minimum total turnover of at least 150 000 EUR for the last 3 years (2011, 2012 and 2013) for Lot 4 and Lot 5.
2.4.2 If the economic operator performs the scope of activities in a period of less than three years, the minimum requirements for establishing the economic and financial eligibility shall be for the economic operator to have met the requirement of sub item 2.4.1 in the years for which data exist.
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2.4.3 The economic operator shall confirm the fulfilment of the minimum requirement of sub items 2.4.1 or 2.4.2 by enclosing the following:
— balance sheet verified by the competent authority, i.e. audited balance sheet or extracts from the balance sheet in cases when the publishing of the balance sheet is prescribed by law in the country in which the economic operator has been registered;
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— statement about the overall operation of the enterprise (data from the Balance sheet issued by the competent authority, i.e. audited Income statement), and where appropriate, from the operation in the area covered with the contract on public procurement for the last three financial years for which such information is available depending on the date when the enterprise was founded or started to operate and depending on the availability of such information.
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2.4.4 If the balance sheet and the Income statement have been a subject to commercial audit, the economic operator can submit them as a proof that the economic operator has fulfilled the minimal term for establishing the economic and financial status, without being additionally verified by a competent authority.
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2.4.5 If the balance sheet and the profit and loss account were not a subject to commercial audit, the economic operator shall submit them upon verification, i.e. following their issuance by a competent authority as proof that the economic operator has met the minimum term for establishing the economic and financial status. In the Republic of Macedonia the competent authority is the Central Register of the Republic of Macedonia.
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2.4.6 The economic and financial eligibility of the economic operator can be supported by another entity, regardless of the legal connections between the economic operator and the aforesaid entity. If the economic operator shall prove its economical and financial eligibility referring to the support of the aforesaid another entity, the economic operator shall validate that support by evidence stating that the aforementioned party shall make available to the economic operator the adequate professional resources. No effective court decision for participation in a criminal organization, corruption, fraud or money laundering should be rendered against the entity providing the financial support.
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2.4.7 If the economic operators submit a tender in a group of economic operators, the economic and financial status shall be established by considering the resources of all members of the group. If the group of economic operators acts by the financial support of a third entity, the economic and financial status shall be established in accordance with the aforementioned.
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Минимално ниво(а) на стандарди:
The economic operator shall confirm the fulfilment of the minimum requirement of sub items 2.4.1 or 2.4.2 by enclosing the following:
— balance sheet verified by the competent authority, i.e. audited balance sheet or extracts from the balance sheet in cases when the publishing of the balance sheet is prescribed by law in the country in which the economic operator has been registered;
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— statement about the overall operation of the enterprise (data from the Balance sheet issued by the competent authority, i.e. audited Income statement), and where appropriate, from the operation in the area covered with the contract on public procurement for the last three financial years for which such information is available depending on the date when the enterprise was founded or started to operate and depending on the availability of such information.
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Техничка и професионална способност:
2.5.1 In order to qualify as competent for execution of the respective public procurement contract from the aspect of technical and professional capacity, the economic operator shall meet the following minimum requirements:
a) At least 3 realized procurement contracts related to the subject of the procurement within the last 3 years. The Economic Operator shall have performed the procurement as an independent supplier, Lot 1, Lot 2, Lot 3, Lot 4 and Lot 5; the equipment offered economic operator no later than delivery of the equipment, which will guarantee the bank guarantee, have provided a service center authorized by the manufacturer of the equipment or has concluded a cooperation agreement with the manufacturer's authorized service of orpemata, where service will be employed
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b) For the offered equipment, the economic operator no later than its delivery, which will also be guaranteed the bank guarantee, have provided a service center authorized by the manufacturer of the equipment or has concluded a cooperation agreement with the manufacturer's authorized service for the equipment, where are employed at least two servicing engineers who have completed the necessary education for servicing and maintenance provided by the equipment manufacturer. The service shall be located within a radius of 60 km of the place in which the equipment has been installed, for Lot 1, Lot 2, Lot 3 and Lot 5, and in radius of 500 km for Lot 4;
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c) It shall hold authorization issued by the equipment manufacturers for participation in a tender, for Lot 1, Lot 2, Lot 3, Lot 4 and Lot 5;
d) Provision of support with spare parts for the offered equipment within a period of 15 years after the expiration of the warranty period for Lot 1, Lot 2, Lot 3 and Lot 5, and 10 years after the expiration of the warranty period for Lot 4;
e) It shall be prepared to accept and observe the requirements provided for in the tender documentation and the technical specifications, Lot 1, Lot 2, Lot 3, Lot 4 and Lot 5.
2.5.2 The Economic operator shall prove that it has met the minimum requirements referred to in item 2.5.1 by submitting the following:
a) List of major supplies of the tenderers or candidates completed in the last three years, with amounts, dates, buyers (contracting authorities or economic operators). If such certificates are impossible to procure for reasons beyond the control of the Economic operator, only with its written statement of supplies it has completed.
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— copies of realized contracts for completed supply of the procurement in subject with separate amount not lower than 100 000 EUR for Lot 1, Lot 2 and Lot 3, and 15 000 EUR for Lot 4 and Lot 5, in the last 3 years;
— at least 3 certificates (recommendations) from the end user for good quality and timely performance of supplies from the procurement in subject, Lot 1, Lot 2, Lot 3, Lot 4 and Lot 5.
b) Not later than the delivery of the equipment the economic operator needs to submit:
— Declaration by the economic operator that , latest by the delivery of the equipment shall submit to the contracting authority Document of registered business activity for maintenance, authorized by the manufacturer of the equipment for Lot 1, Lot 2, Lot 3, Lot 4 and Lot 5, or notarized copy of the agreement for cooperation with the authorized service of the equipment manufacturer, based in Macedonia.
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— The Economic operator not later than the delivery of the equipment shall submit to the contracting authority Authorization / Agreement with the manufacturer for service and maintenance (for Lot 1, Lot 2, Lot 3, Lot 4 and Lot 5).
— Declaration by the economic operator that, no later than the delivery of the equipment shall submit to the contracting authority Proof of 2 employed engineers with completed training for service and maintenance, CVs for the engineers and certificates issued by the equipments manufacturer for completed training for service and maintenance for the employed engineers (for Lot 1, Lot 2, Lot 3, Lot 4 and Lot 5).
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c) Original authorizations from the manufacturers for participation in a tender (For Lot 1, Lot 2, Lot 3, Lot 4 and Lot 5).
d) Statement of the equipment manufacturer for the provision of support with spare parts for the offered equipment in the period of 15 years after the expiration of the warranty period for Lot 1, Lot 2, Lot 3 and Lot 5, and 10 years after the expiration of the warranty period for Lot 4.
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e) Statement that it accepts the requirements of the tender documentation and the technical specifications (For Lot 1, Lot 2, Lot 3, Lot 4 and Lot 5).
2.5.3 The documents of lines d) and e) shall be prepared and signed by the economic operator and do not require verification by a competent authority.
2.5.4 The technical and professional capacity of the economic operator can be supported by another entity, regardless of the legal connections between the economic operator and that entity. If the economic operator proves its technical and professional capacity by referring to the support of the aforesaid another entity, the economic operator shall validate that support by evidence stating that the aforementioned party shall make available to the economic operator the adequate technical and professional resources. No effective court order for participation in a criminal organization, corruption, fraud or money laundering should be rendered against the entity providing the technical or professional support.
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2.5.5 If the economic operators submit a tender as a group of economic operators, the technical and professional capacity shall be established by considering the resources of all members of the group. If the group of economic operators acts with the technical and professional support of a third entity, or third entities, the technical and professional capacity shall be established according to the aforementioned.
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Извршување на договорот
Потребни депозити и гаранции:
4.6.1 As part of the tender, the economic operator shall obtain a guarantee of the tender (participation guarantee) in the amount of no less than 2 % of the total value of the tender, VAT not included.
4.6.2 The guarantee shall be in the form of bank guarantee. All the banks are acceptable for the Contracting Authority.
4.6.3 The guarantee shall be submitted in the original. Copies shall not be accepted. The guarantee shall have a validity period of at least 30 days following the expiry date of the tender. Every offer not containing a guarantee of the tender, or containing guarantee of the tender not in accordance with the requirements of the tender documentation, shall be rejected by the Contracting Authority as unacceptable.
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4.6.4 The guarantee of the tender of the unsuccessful economic operators shall be returned within 7 days following the signing of the contract with the most favourable economic operator.
4.6.5 The guarantee of the tender may be activated, should the tenderer withdraw the tender prior to the expiration of the validity period, or fail to accept the correction of arithmetical errors by the Committee, or sign the public procurement contract or to provide a guarantee for high quality execution of contract, in which case the Contracting Authority shall reserve the right to award the public procurement contract to the tenderer ranked as second most favourable.
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Постапка
Датум на отворање на понудите: 2014-09-30 📅
Информации за овластени лица и постапка за отворање:
All interested parties can take participation at the public bid opening. Only the authorized representatives of the bidders present on the opening can give remarks to the minutes from the bid opening.
The authorized representatives of the economic operators present on the opening must have had their authorization signed by the responsible person of the economic operator. All authorized representatives of the economic operators, present on the public opening, should sign the registration list.
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Јазици
Јазик: англиски 🗣️
Други јазици: Macedonian language

Договорен орган
Контакт
Интернет-адреса: www.moh.gov.mk 🌏
Име: Ministry of Heath of Republic of Macedonia
Поштенска адреса: 50 Divizija 6

Референца
Идентификатори
Референтен број доделен од договорниот орган: 30/2014

Дополнителни информации
Тело за преглед
Име: State Commission for appeals on public procurement
Земја: Северна Македонија 🇲🇰
Информации за роковите за приговор:
Each economic operator having legal interest in obtaining the public procurement contract and having undergone or could undergo damage of a possible violation of the provisions of the Public Procurement Law can claim legal protection against the decisions, activities or failing to take activities by the contracting authority in the procedure of awarding public procurement contract. The right to appeal in procedure which is finalized by e-auction is taken in after the Decision for election of most favorable bidder or annulment of the procedure is passed by.
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Извор: OJS 2014/S 178-315471 (2014-09-12)