Procurement of Enzyme Hemiluminescence Tests (CLIA metod)

PHI Institute of Public Health of Republic of Macedonia Skopje

Procurement of enzyme hemiluminescence tests (CLIA metod).

Рок

Рокот за прием на понудите беше 2021-03-08. Набавката беше објавена на 2021-02-08.

Кој?

• PHI Institute of Public Health of Republic of Macedonia Skopje

Што?

• Реагенси и контрастни средства › Лабораториски реагенси

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2021-02-08	Оглас за договор

Оглас за договор (2021-02-08)
Предмет
Опсег на набавката
Наслов: Laboratory reagents
Референтен број: 01316/2021
Краток опис: Procurement of enzyme hemiluminescence tests (CLIA metod).
Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Лабораториски реагенси 📦
Дополнителен CPV: Лабораториски реагенси 📦
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: Тело уредено со јавно право
Име на органот кој доделува: PHI Institute of Public Health of Republic of Macedonia Skopje
Поштенска адреса: 50 Divizija Br.6
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: http://www.iph.mk 🌏
Е-пошта: publichealthinstitutemk@gmail.com 📧
Телефон: +389 23125044 📞
Факс: +389 23223354 📠
URL за документи: https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/55d18ce3-d0a3-4234-b739-979f82aa7078/1 🌏
URL за учество: https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/55d18ce3-d0a3-4234-b739-979f82aa7078/1 🌏

Референца
Датуми
Датум на испраќање: 2021-02-08 📅
Рок за поднесување: 2021-03-08 📅
Датум на објавување: 2021-02-12 📅
Идентификатори
Број на огласот: 2021/S 030-075784
OJ-S издание: 30
Дополнителни информации

https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/55d18ce3-d0a3-4234-b739-979f82aa7078/1

Предмет
Опсег на набавката
Наслов на делот: 1
Број на дел: 1
Краток опис: 54 'Tests for immunoglobulin M rubella antibodies (RUBELLA IgM).
Времетраење: 12 месеци
Дополнителни информации:

https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/55d18ce3-d0a3-4234-b739-979f82aa7078/1

Наслов на делот: 2
Број на дел: 2
Краток опис: 55 'Tests for immunoglobulin G Toxoplasma antibodies (TOXO IgG).
Наслов на делот: 3
Број на дел: 3
Краток опис: 56 'Tests for immunoglobulin M Toxoplasma antibodies (TOXO IgM).
Наслов на делот: 4
Број на дел: 4
Краток опис: 51 ' Tests for Immunoglobulin G cytomegalovirus antibodies (CMV IgG).
Наслов на делот: 5
Број на дел: 5
Краток опис: 53 'Tests for immunoglobulin G antibodies to rubella (RUBELLA IgG).
Наслов на делот: 6
Број на дел: 6
Краток опис: 9428 '' Tests for hepatitis B virus surface antigen (HBsAg).
Наслов на делот: 7
Број на дел: 7
Краток опис: 9425 '' Tests for Immunoglobulin M Antibodies to Hepatitis A Virus (HAV IgM).
Наслов на делот: 8
Број на дел: 8
Краток опис:

9431 '' Test for detection of immunoglobulin M antibodies to hepatitis B virus antigen c (ANTI HBc IgM).

Наслов на делот: 9
Број на дел: 9
Краток опис: 9578 'Test for detection of HCV antigen.
Наслов на делот: 10
Број на дел: 10
Краток опис: 9448 'Test for detection of IgG antibodies to hepatitis A virus (HAV AB).
Наслов на делот: 11
Број на дел: 11
Краток опис: 9451 'Test for detection of total antibodies to HIV-1 + HIV-2 (HIV Combo).
Наслов на делот: 12
Број на дел: 12
Краток опис: 9445 'Test for detection of total antibodies to hepatitis B virus (HBS AB).
Наслов на делот: 13
Број на дел: 13
Краток опис: 9437 'Test for detection of total antibodies to hepatitis C virus (Anti HCV).
Наслов на делот: 14
Број на дел: 14
Краток опис: 9901 'Tests for immunoglobulin G antibodies to cytomegalovirus (CMV IgM).
Наслов на делот: 15
Број на дел: 15
Краток опис:

9434 'Test for detection of total antibodies against hepatitis B internal antigen (ANTI HBc).

Наслов на делот: 16
Број на дел: 16
Краток опис:

9579 'Epstein Barr virus (EBV VCAIgG) antibody detection test applicable to CLIA apparatus or equivalent to 100 T.

Наслов на делот: 17
Број на дел: 17
Краток опис:

9577 'Test for detection of Epstein Barr virus antibody (EBV VCAIgM) applicable to CLIA apparatus or equivalent to 100 T.

Наслов на делот: 18
Број на дел: 18
Краток опис:

9887 Test for qualitative and quantitative determination of IgG antibodies to SARS CoV 2 IgG.

Наслов на делот: 19
Број на дел: 19
Краток опис: 9888 Tests for Immunoglobulin M antibody for SARS COV 2 IgM.
Место на извршување
Главна локација или место на извршување: PHI Institute of Public Health at R.M. - Skopje.

Правни, економски, финансиски и технички информации
Услови за учество
Економска и финансиска состојба:

— statement by the economic operator than it has not been sentenced, in the last 5 years, with effective court decision for participation in criminal organization, corruption, fraud or money laundering under Article 88 Paragraph 1 from the Law on Public procurement,

— certificate that it is not subject to bankruptcy procedure issued by competent authority,

— certificate that it is not subject to liquidation procedure issued by competent authority,

— certificate for paid taxes, contributions and other public duties by the competent authority in the country where that economic operator is established,

— certificate from the legal entities penal registry that it is not being imposed a side sanction —…

… prohibition to participate in public competitions, public procurement contract award and public-private partnership contract award procedures,

… temporary or permanent prohibition to perform certain professional activity,

— certificate that it is not being sanctioned for misdemeanor with an effective court decision, resulting in prohibition for pursuing professional activity or duty, i.e. temporary prohibition for performing certain activity.

Минимално ниво(а) на стандарди:

Certificate of registered activity (form BPD) as proof that he is registered as a natural or legal person for carrying out the activity related to the subject of the public procurement contract or proof that he belongs to an appropriate professional association in accordance with the regulations of the country where he is registered. In the Republic of North Macedonia the competent authority for the issuance of this document is the Central Register of the Republic of North Macedonia — copy (true to the original medicines wholesale/distribution authorization in the territory of the Republic of Macedonia issued by the Ministry of Health under the law on medicines and medical devices.

Техничка и професионална способност:

— reference list-list of deliveries made in the last year of the tests that are subject to procurement,

— certificate of completed deliveries issued by at least three recipients from the reference list of activity, trade with drugs and medical devices,

— reference list from the manufacturer of tests / reagents with minimum 3 references in Europe where the same tests are subject to procurement and delivery,

— list of users of offered tests / reagents and / or apparatus in the EU issued and certified by the economic operator.

Минимално ниво(а) на стандарди:

— document certified by the manufacturer (Original authorization from the manufacturer) of the requested procurement object that the economic operator has authorization and is allowed to apply for participation in the tender procedure,

— reference list - list of deliveries made in the last year of the tests that are subject to procurement,

— certificate of completed deliveries issued by at least three recipients of the reference list of activity of trade in drugs and medical devices,

— reference list of the manufacturer of tests / reagents with minimum 3 references in Europe where the same tests are subject to procurement and delivery,

— list of users of offered tests / reagents and / or apparatus in the EU issued and certified by the economic operator,

— confirmation from the manufacturer of the device that the tests / reagents have a certificate for use of the appropriate device,

— statement that the economic operator will provide authorized service for the device that will be available 24/7 and will take care of calibration, service and maintenance of the devices for smooth operation during the use of its reagents without compensation,

— statement that the Quantities for the Consumables for work are sufficient for the smooth performance of all required analyzes that are detailed in the specification with quantities. If the offered quantities of consumables are not sufficient for smooth execution of the analyzes, the bidder will bear all costs that arose from the inability to perform the overall analyzes, ie they will provide the necessary materials free of charge,

— IT IS MANDATORY TO BE MARKED. MACEDONIAN LANGUAGE TRANSLATION MUST BE SUBMITTED FOR THE BASIC CHARACTERISTICS OF REAGENTS AND PROCEDURES for those involved, with included material safety sheet (MSDS)for the offered reagents. ON THE BASIS OF THAT, IT WILL BE DETERMINED WHETHER THE OFFERED REAGENTS MEET THE REQUIREMENTS FROM THE TECHNICAL SPECIFICATION,

— statement that the offered reagents correspond (are equivalent) to the relevant parts of the tender specification (for each part individually - for those parts for which the economic operator has submitted a bid),

— statement from the economic operator that the goods to be delivered will have a shelf life of at least 6 months from the day of delivery of the subject of procurement,

— the reagents are for in vitro diagnostics and have CE certificate or equivalent.

Постапка
Правна основа: 32014L0024
Информации за електронска аукција:

https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/55d18ce3-d0a3-4234-b739-979f82aa7078/1

Време за прием на понуди: 10:00
Јазици на кои може да се поднесат понуди или барања за учество: англиски 🗣️
македонски 🗣️
Датум на отворање на понудите: 2021-03-08 📅
Време на отворање на понудите: 10:00
Место: PHI Institute of Public Health at R.M. - Skopje.

Договорен орган
Контакт
URL на документи: https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/55d18ce3-d0a3-4234-b739-979f82aa7078/1 🌏

Дополнителни информации
Тело за преглед
Име: State Commission for Appeals
Поштенско место: Skopje
Земја: Северна Македонија 🇲🇰
Телефон: +389 23251251 📞
Е-пошта: dkzjn@gs.gov.mk 📧
Извор: OJS 2021/S 030-075784 (2021-02-08)

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