TESTS AND REAGENTS FOR MOLECULAR SCREENING OF BLOOD DONORS, ORGAN AND TISSUE DONORS USED ON PROCLEIX PANTHER SYSTEM DEVICE OR EQUIVALENT

Institute of Transfusion Medicine

TESTS AND REAGENTS FOR MOLECULAR SCREENING OF BLOOD DONORS, ORGAN AND TISSUE DONORS USED ON PROCLEIX PANTHER SYSTEM DEVICE OR EQUIVALENT according tehnical specification
For the offered tests, each bidder is required to provide all the necessary reagents and consumables in the amount needed to obtain a definitive result and for the system to work smoothly, and all of this is included in the price of the offered tests.

Рок

Рокот за прием на понудите беше 2022-11-14. Набавката беше објавена на 2022-10-16.

Кој?

• Institute of Transfusion Medicine

Што?

• Реагенси и контрастни средства › Реагенси за тестирање крв

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2022-10-16	Оглас за договор

Оглас за договор (2022-10-16)
Предмет
Опсег на набавката
Наслов: Blood-testing reagents
Референтен број: 17350/2022
Краток опис:

TESTS AND REAGENTS FOR MOLECULAR SCREENING OF BLOOD DONORS, ORGAN AND TISSUE DONORS USED ON PROCLEIX PANTHER SYSTEM DEVICE OR EQUIVALENT according tehnical specification For the offered tests, each bidder is required to provide all the necessary reagents and consumables in the amount needed to obtain a definitive result and for the system to work smoothly, and all of this is included in the price of the offered tests.

Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Реагенси за тестирање крв 📦
Место на извршување
NUTS регион: Северна Македонија 🏙️

Постапка
Вид на постапка: Отворена постапка
Вид на понуда: Поднесување за сите делови
Критериуми за доделување
Најниска цена

Договорен орган
Идентитет
Земја: Северна Македонија 🇲🇰
Вид на органот кој доделува: Друго
Име на органот кој доделува: Institute of Transfusion Medicine
Поштенска адреса: St Mother Tereza 17
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: http://www.itm.org.mk 🌏
Е-пошта: transfuziologija@gmail.com 📧
Телефон: +38 923226923 📞
Факс: +38 923119227 📠
URL за документи: http://www.e-nabavki.gov.mk 🌏
URL за учество: http://www.e-nabavki.gov.mk 🌏

Референца
Датуми
Датум на испраќање: 2022-10-16 📅
Рок за поднесување: 2022-11-14 📅
Датум на објавување: 2022-10-21 📅
Идентификатори
Број на огласот: 2022/S 204-583197
OJ-S издание: 204
Дополнителни информации
Any person mast have authorisation letter from his/her economic operator

Предмет
Опсег на набавката
Краток опис:

TESTS AND REAGENTS FOR MOLECULAR SCREENING OF BLOOD DONORS, ORGAN AND TISSUE DONORS USED ON PROCLEIX PANTHER SYSTEM DEVICE OR EQUIVALENT according tehnical specification

For the offered tests, each bidder is required to provide all the necessary reagents and consumables in the amount needed to obtain a definitive result and for the system to work smoothly, and all of this is included in the price of the offered tests.

Tests for multiplex molecular screening of blood donors, organ donors and tissues for the following viral markers: HCV RNA, HBV DNA, HIV-1 RNA, HlV-2 RNA and HEV RNA from one test tube with the principle of NAT (nucleic acid testing) technology applied to the device PROCLEIX PANTHER SYSTEM or equivalent -55.000 tests

Времетраење: 365 дена
Место на извршување
Главна локација или место на извршување:

Institute of Tasfusion Medicine of Republic of Macedonia — Skopje, located at St. Mother Tereza 17 Skopje

Правни, економски, финансиски и технички информации
Услови за учество
Способност за вршење на стручната дејност:

-Document for registered activity – DRD form or certificate of registered activity

- Decision for wholesale of medical devices in accordance with the Law on Medicines and Medical Devices.

• statement of the economic operator that the economic operator or the person who is a member of the

management or of the supervisory board of such economic operator or who is authorized for representation or

decision-making or supervision thereof has not been pronounced in the last five years with a valid court verdict

for committed criminal act including elements of the criminal acts participation in criminal association, corruption,

evasion of taxes and contribution, terrorism or offences related to terrorist activities, money laundering and

terrorism financing and child labor and trafficking in humans, as prescribed with the Criminal Code.

• confirmation of paid taxes, contributions and other public dues issued by a competent authority in the country

where the economic operator is registered;

• confirmation that the economic operator is not subject to an opened bankruptcy procedure by a competent

authority;

• confirmation that the economic operator is not subject to an opened liquidation procedure by a

competentauthority confirmation from the Registry of penalties for committed criminal acts of the legal entities that the economic

operator was not pronounced with a second penalty prohibiting the participation in the public call procedures,

the public procurement contract award procedures and the public private partnership procedures;

• confirmation from the Registry of penalties for committed criminal acts of the legal entities that the economic

operator was not pronounced with a second penalty for…

… temporary prohibition for performing certain activity;

… permanent prohibition for performing certain activity;

• confirmation that there is no legally effective judgment imposing a misdemeanor sanction – prohibition to

perform a profession, activity or duty imposed against the economic operator

• confirmation that there is no legally effective judgment imposing a misdemeanor sanction – temporary

prohibition for performing certain activity imposed against the economic operator

Техничка и професионална способност:

The economic operator should provide a catalog or other documents with technical specifications of the offered reagents and consumables that will prove the requirements of the technical specification with clearly marked pages for each required characteristic and that it should be stated in them that the reagents and consumables are intended for testing of blood from blood donors and instructions for using them;

- The economic operator should guarantee that the tests offered are applicable to the PROCLEIX PANTHER SYSTEM device or equivalent

- The economic operator needs to have proof from the manufacturer that the reagents and consumables are intended for testing blood from blood donors, organs and tissues.

- The economic operator is required to have certificates/contracts with transfusion institutions as users from the EU (from at least 3 countries) of the offered reagents and consumables;

- The economic operator is required to have publications on sensitivity and specificity for the results obtained from the reagents that have been published in relevant journals in the field of transfusion medicine and/or reports of appropriate bodies at the Council of Europe or WHO;

Минимално ниво(а) на стандарди:

- Catalog or other documents with technical specifications of the offered reagents and consumables that will prove the requirements of the technical specification with clearly marked pages for each required characteristic and that it is stated in them that the reagents and consumables are intended for testing blood from donors and to provide instructions for using them;

- Statement that the tests offered are applicable to the PROCLEIX PANTHER SYSTEM device or equivalent

- A statement from the manufacturer that the reagents and consumables are intended for testing blood from blood donors, organs and tissues.

- To submit certificates/contracts to transfusion facilities as users from the EU (from at least 3 countries) of the offered reagents and consumables;

- To submit proof of publications on sensitivity and specificity for the results obtained from the reagents that have been published in relevant journals in the field of transfusion medicine and/or reports of appropriate bodies at the Council of Europe or WHO;

Постапка
Правна основа: 32014L0024
Време за прием на понуди: 11:00
Јазици на кои може да се поднесат понуди или барања за учество: македонски 🗣️
Период на важност на понудата: 3 месеци
Датум на отворање на понудите: 2022-11-14 📅
Време на отворање на понудите: 11:00
Место: Pho Institute of Transfusion Medicine of The Republic of Macedonia Skopje, located on Mother Tereza 17
St.,Skopje — Meeting Hal
Дополнителни информации: Any person mast have authorisation letter from his/her economic operator

Договорен орган
Идентитет
Друг вид договорен орган: Institute of Transfusion Medicine
Контакт
Контактна точка: Blagica Krstevska
Интернет-адреса: www.itm.org.mk 🌏
URL на документи: www.e-nabavki.gov.mk 🌏
URL за учество: www.e-nabavki.gov.mk 🌏
Интернет-адреса: www.e-nabavki.gov.mk 🌏
URL за документи: www.e-nabavki.gov.mk 🌏

Дополнителни информации
Тело за преглед
Име: State commission on public procurement
Поштенска адреса: Bull.‘Ilinden’ 63A 1000 Skopje, Republic of Macedonia
Поштенско место: Skopje
Поштенски број: 1000
Земја: Северна Македонија 🇲🇰
Телефон: +389 23251251 📞
Е-пошта: dkzjn@gov.mk 📧
Факс: +389 23251250 📠
Извор: OJS 2022/S 204-583197 (2022-10-16)

Нови набавки во поврзани категории 🆕

Медицинска опрема, фармацевтски производи и производи за лична нега (19 нови набавки)

Фармацевтски производи (4)

Разни лекови (2)

Реагенси и контрастни средства (2)