Public procurement notice: Contract Notice
Published: 2018-03-29
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33696200
Estimated value:  EUR
Submission deadline: 2018-05-07
Award criteria: Lowest price

Technical requirements: Reagents, materials and calibrators for the control of blood transmitted diseases for apparatus Architect i2000sr '' or equivalent '' for Chemylumimsence Test Method
Pho Institute of Transfusion Medicine of Republic of Macednia-Skopje located at Vodnjanska 17 St.,Skopje
Part 1 — Reagent for detection of HbsAg applicable to immune analyzer Architect i2000sr "or equivalent" for Chemylumimsence test method.
Part 2 — Reagent for detection of Anti HCV applicable to immune analyzer Architect i2000sr "or equivalent" for Chemylumimsence test method.
Part 3 — Reagent for detection of HIV Ag/Att Combo applicable to immune analyzer Architect i2000sr "or equivalent" for Chemylumimsence test method.
Part 4 — Reagent for detection of Syphilis (TP) applicable to immune analyzer Architect i2000sr "or equivalent" for Chemylumimsence test method.
Part 5 — HbsAg calibrator applicable to immune analyzer Architect i2000sr "or equivalent" for Chemylumimsence test method.
Part 6 — HbsAg control applicable to immune analyzer Architect i2000sr "or equivalent" for Chemylumimsence test method.
Part 7 — Anti HCV calibrator applicable to immune analyzer Architect i2000sr "or equivalent for Chemylumimsence test method.
Part 8 — Anti HCV control applicable to immune analyzer Architect i2000sr "or equivalent" for Chemylumimsence test method.
Part 9 — HIV calibrator applicable to immune analyzer Architect i2000sr "or equivalent" for Chemylumimsence test method.
Part 10 — HIV control applicable to immune analyzer Architect i2000sr "or equivalent" for Chemylumimsence test method.
Part 11— Syphilis calibrator applicable to immune analyzer Architect i2000sr "or equivalent" for Chemylumimsence test method.
Part 12 — Syphilis control applicable to immune analyzer Architect i2000sr "or equivalent" for Chemylumimsence test method.
Part 13 — Rubber bottle caps for reagents applicable to immune analyzer Architect i2000sr "or equivalent" for Chemylumimsence test method.

Eligibility requirements: — Document for registered activity — DRD form or certificate of registered activity, — Decision for wholesale trade with medical supplies under the Law on medicines and Medical appliances, — a statement by the economic operator that it has not been imposed a legally valid court decision for participation in criminal organization, corruption, fraud or money laundering for the last 5 years; — a certificate by a competent authority that a bankruptcy procedure has not been initiated, — a certificate by a competent authority that a liquidation procedure has not been initiated, — a certificate by a competent authority from the country where that economic operator is registered for paid taxes, contributions and other public duties, — a certificate by the Register of sentences for committed crimes of legal entities that a secondary sentence prohibition on participation in open call procedures, awarding public procurement contracts and contracts for public private partnership, has not been imposed, — a certificate by the Register of sentences for committed crimes of legal entities that a secondary sentence. Temporary or permanent prohibition on performing a certain activity has not been inpoused and — a certificate that a misdemeanor sanction resulting in prohibition for practicing profesion performing activity or duty, i.e. temporary prohibition for performing a particular activity has not been imposed by a legally valid court decision. For registered medical supplies: — For the offered goods the economic operator must have provided an Approval for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on medicines and Medical devices. For unregistered medical supplies: — For the offered goods the economic operator must have provided a document that authorizes the import (Approval for intervention import) under the Law on Medicines and Medical devices. For registered medical supplies: — a Decision for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on medicines and Medical devices. For unregistered medical supplies: — Import license (Authorization for Intervention Import) under the Law on medicines and Medical devices.
For registered medical supplies: — For the offered goods the economic operator must have provided an Approval for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on medicines and Medical devices. For unregistered medical supplies: — For the offered goods the economic operator must have provided a document that authorizes the import (Approval for intervention import) under the Law on Medicines and Medical devices. For registered medical supplies: — a Decision for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on medicines and Medical devices. For unregistered medical supplies: — Import license (Authorization for Intervention Import) under the Law on medicines and Medical devices.
For registered medical supplies: — For the offered goods the economic operator must have provided an Approval for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on medicines and Medical devices. For unregistered medical supplies: — For the offered goods the economic operator must have provided a document that authorizes the import (Approval for intervention import) under the Law on Medicines and Medical devices.
For registered medical supplies: — a Decision for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on medicines and Medical devices. For unregistered medical supplies: — Import license (Authorization for Intervention Import) under the Law on medicines and Medical devices.