SERVICE FOR fractionation (processing) of human plasma

Institute of Transfusion Medicine

SERVICE FOR fractionation (processing) of human plasma.

Рок

Рокот за прием на понудите беше 2012-07-23. Набавката беше објавена на 2012-05-30.

Кој?

• Institute of Transfusion Medicine

Што?

• Хематолошки потрошен материјал › Екстракти од плазма

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2012-05-30	Оглас за договор
2012-06-25	Дополнителни информации

Оглас за договор (2012-05-30)
Предмет
Опсег на набавката
Наслов: plasma extracts
Количина или опсег: 5 000 litres plasma for each year
Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Услуги
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Екстракти од плазма 📦

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: Vodnjanska 17
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Е-пошта: transfuziologija@gmail.com 📧
Телефон: +389 23226923 📞
Факс: +389 23119227 📠

Референца
Датуми
Датум на испраќање: 2012-05-30 📅
Рок за поднесување: 2012-07-23 📅
Датум на објавување: 2012-06-01 📅
Идентификатори
Број на огласот: 2012/S 103-173067
OJ-S издание: 103

Предмет
Опсег на набавката
Проценета вредност без ДДВ: 1,00 💰
6 347 358,00 💰
Краток опис: SERVICE FOR fractionation (processing) of human plasma.
Референтен број: 08/2012
Место на извршување
Главна локација или место на извршување:

SERVICE FOR fractionation (processing) of human plasma will be done at economic operator.

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

The contracting authority shall exclude from the procedure for awarding public contracts any economic operator which:

— in the last 5 years has been rendered a final judgment for participation in a criminal organization, corruption, fraud or money laundering,

— has been prononced prohibition on participation in public tender procedures, awarding contracts for public-private partnership,

— has been prononced prohibition for temporary or permanent performing certain activities,

— is in bankruptcy or liquidation proceedings,

— has unpaid taxes, contributions and other public fees,

— has a misdemeanor sanction - prohibition on performing profession, activity or duty, ie temporary prohibition for performing certain activities and,

— gives false information or fails to submit the data requested by the contracting authority.

Економска и финансиска состојба:

— report on the balance certified by a competent authority, ie audited balance sheets or extracts from the balance sheet where publication of balance sheets is prescribed by law in the country where the economic operator is registered, or,

— statement of overall turnover of the company (data from the income statement issued by the competent authority, ie audited balance sheet) and, where appropriate, of turnover in the area covered by the contract and most of the last three financial years for which such data are available depending on the date the company was founded or started to work and depending on the availability of such information or,

— audit report which should be positive and issued by a foreign reputable institution, registered for performing audit. The audit report should contain data on the overall economic performance of foreign candidates for the last three years.

Минимално ниво(а) на стандарди:

— The total turnover in the last 3 (three) years to be not less than 10 000 000 (ten million) EUR.

Техничка и професионална способност:

— Proof of purchases from the same or similar kind in the last three years in the Republic of Macedonia or in the EU Member Countries, candidate countries for membership of the EU, Norway, Switzerland, USA, Canada, Australia and Japan,

— Declaration of technical equipment and capacity of economic operator to deliver the procurement (equipment, storage conditions and facilities, vehicles),

— Decision of the competent authority of the Ministry of Health of RM which is an approval for marketing the subject of procurement on the territory of RM, or to provide an authorization for marketing the subject of procurement after the received notification that it is selected best bidder but before the signing of the contract (Law on medicines and medical devices Official Gazette of RM no.160/07),

— Decision to perform business activity - wholesale of medical devices, supplies, or to provide an authorization marketing the subject of procurement after the received notification that it is selected best bidder but before the signing of the contract on the territory of RM (in accordance with the Law on drugs and medical devices Official Gazette of RM no.160/07),

— Statement that the bidder is obliged to obtain consent from the Institute for Transfusion Medicine of RM – Skopje, if subcontractors perform some parts of the procurement,

— Statement that the bidder will provide the necessary permits from local and international authorities that are required for -marketing of the subject of procuremnt,

— Statement that the bidder will produce and deliver a minimum quantity of plasma products according to technical specification,

— Statement that the bidder will take blood plasma and provide transportation to the place of its fractionation. From the moment of taking plasma the risk of whole or partial plasma’s decay takes the bidder, and it is obliged to compensate the damage done,

— Statement that the bidder will guarantee the process of fractionation that provides dual inactivation of encapsulated and noncapsulated viruses and subsequently purifying the products with high purity,

— Statement that the bidder for each series of products have EU certification "EU Batch Release Certificate" (OCABR), a Information form on sales "Marketing Information Form (MIF), production and test protocol of the supplier, and complete plasma PUL documentation in accordance with EU recommendations concerning plasma products. a,

— Quantities of produced / processed quantities will be expressed in international units or grams depending on the type of product,

— Statement that the bidder has valid GMP (GMP) certificate issued by competent authority. Bidder products must correspond to the EMEA 2001 guidance. The contracting authority shall be entitled to appoint its competent staff to supervise the process of processed, and costs for this will be borne by the bidder,

— Statement that bidder will be responsible for implementing the NAT tests of plasma that will be subject of processing and for this the necessary certifications and documentation will be provided,

— Statement that If there is a need of destruction of bags with plasma of any reason, before destruction bidder needs a written consent of the contracting authority,

— Plasma which is subject to fractionation and the other supplied components will be undertaken by authorized persons from the Institute for Transfusion,

— Statement that the bidder accepts the terms of the open procedure.

Минимално ниво(а) на стандарди:

— the bidder needs to have committed a purchase of the same or similar kind in the last three years,

— technical equipment and capacity of the economic operator to deliver the procurement (equipment, storage conditions and facilities, vehicles),

— Bidder is required to obtain accordance of the PHI Institute for Transfusion Medicine of RM, if necessary subcontractors to perform some parts of the subject of purchase,

— Bidder shall provide the necessary permits from local and international authorities that are required for marketing of the subject of procurement,

— Bidder is obliged to produce and deliver a minimum quantity of plasma products according to technical specification,

— Bidder is obliged to take blood plasma and to provide transportation to the place of its fractionation,

— Bidder shall guarantee the process of fractionation which provides dual inactivation of encapsulated and non encapsulated viruses subsequently purifying the products with high purity,

— Each batch of product must be EU certified "EU Batch Release Certificate" (OCABR), a form with sales information "Marketing Information Form (MIF), production and test protocol of the supplier and complete plasma PUL documentation in accordance with EU recommendations on plasma products,

— The contracting authority should submit plasma in bags in accordance with standard FFP together with sample tubes for NAT testing for HBV, HCV and HIV,

— Bidder is obliged to provide transport of the plasma to the place of production 4 times during a calendar year upon written request of the contracting authority within 30 days,

— To carry out delivery of the products of plasma fractionation at least 4 times in one calendar year upon written request of the PHI Institute for Transfusion Medicine RM - Skopje within 30 days,

— Quantities of produced/processed quantities will be expressed in units or grams depending on the type of product,

— Bidder must have valid GMP (GMP) certificate issued by competent authority. Bidder products must correspond to the EMEA 2001 guidance. The contracting authority shall be entitled to appoint its competent staff to supervise the process of processed, and costs for this will be borne by the bidder,

— The bidder is responsible for implementing the NAT tests of plasma that will be subject of processing and for this the necessary certifications and documentation will be provided,

— If there is a need of destruction of bags with plasma of any reason, before destruction bidder needs a written consent of the contracting authority,

— Plasma which is subject to fractionation and the other supplied components will be undertaken by authorized persons from the Institute for Transfusion.

Извршување на договорот
Потребни депозити и гаранции: 3 % for participation in publik procurement and 10 % for contracting
Извршувањето на услугата е резервирано за одредена професија:

— Document for registered activity - DRD form issued by the Central Registry or equivalent document issued by competent authority in the country where the bidder is registered and,

— Valid Decision for performing trade with medicines issued by the Ministry of Health of the Republic of Macedonia or equivalent document issued by competent authority in the country where the bidder is registered.

Постапка
Времетраење на рамковниот договор во месеци: 36
Период на важност на понудата: 180 дена
Датум на отворање на понудите: 2012-07-23 📅
Место на отворање: Institute of transfusion medicine Skopje, Vodnjanska 17 Macedonia.
Место: Institute of transfusion medicine Skopje, Vodnjanska 17 Macedonia.
Информации за овластени лица и постапка за отворање: At least one, autorized by economic operator.
Јазици
Други јазици: Macedonian.

Договорен орган
Идентитет
Друг вид договорен орган: Other
Контакт
Контактна точка: Institute of Transfusion Medicine

Референца
Датуми
Почетен датум: 2013-01-01 📅
Краен датум: 2015-12-31 📅
Идентификатори
Референтен број доделен од договорниот орган: 08/2012

Дополнителни информации
Тело за преглед
Име: State comission for appeal procedures
Поштенска адреса: Ilinden 63
Поштенско место: Skopje
Поштенски број: 1000
Земја: Северна Македонија 🇲🇰
Телефон: +389 3251251 📞
Интернет-адреса: http://dkzjn.gov.mk 🌏
Факс: +389 3251250 📠
Извор: OJS 2012/S 103-173067 (2012-05-30)

Дополнителни информации (2012-06-25)
Предмет
Метаподатоци на огласот
Вид на документ: Дополнителни информации

Референца
Датуми
Датум на испраќање: 2012-06-25 📅
Датум на објавување: 2012-06-28 📅
Идентификатори
Број на огласот: 2012/S 122-201208
Се однесува на оглас: 2012/S 103-173067
OJ-S издание: 122
Извор: OJS 2012/S 122-201208 (2012-06-25)

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