Public procurement notice: Contract Notice
Published: 2017-05-10
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33696200
Estimated value: 38000000 MKD
Submission deadline: 2017-06-13
Award criteria: Lowest price

Technical requirements: Part — 1 ELISA — enzyme immunoassay for qualitative detection of Hepatitis Bs (surface) antigen in human serum or plasma, at least 6th generation applicable to the immune analyser VER2000 ‘or equivalent’.
Part — 2 ELISA — enzyme immunoassay for qualitative detection of HIV p24 antigen and specific antibodies against HIV virus type 1 and 2 (HIV 1 including HIV 1 subtype O and HIV 2) in human serum or plasma, at least 4th generation applicable to immune analyser VER2000 ‘or equivalent’.
Part — 3 ELISA — enzyme immunoassay for qualitative detection of Hepatitis C virus in human serum or plasma, at least 4th generation applicable to immune analyser VER2000 ‘or equivalent’.
Part — 4 ELISA — enzyme immunoassay for qualitative detection of specific antibodies against Treponema pallidum virus in human serum or plasma, at least 4th generation applicable to immune analyser VER2000 ‘or equivalent’.
Part 5 — ELISA — Referent liquids set for validation of all functions applicable to immune analyser VER2000 ‘or equivalent’ with volume ratio 1:1:1.
Part 6 — Non-coated microtiter plates for validation of all functions applicable to immune analyser VER2000 ‘or equivalent’.
Part 7 — Electrically conductive accessories of 300 µl for pipetting and dispersing, applicable to immune analyser VER2000 ‘or equivalent’.
Part 8 — Electrically conductive accessories of 1.100 µl for pipetting and dispersing, applicable to immune analyser VER2000 ‘or equivalent’.
Part 9 — Concentrated liquid dezifisiens and cleaner applicable to immune analyser VER2000 ‘or equivalent’.
Part 10 — Additional reagent containing peroxidase and serves for obtaining coloured reaction in process of testing sample of serum or plasma with appropriate ELISA — enzyme immunoassay, applicable to immune analyser VER2000 ‘or equivalent'.
Part 11 — Reagent for detection of HbsAg applicable to immune analyser Architect i2000sr 'or equivalent'.
Part 12 — Reagent for detection of Anti HCV applicable to immune analyser Architect i2000sr 'or equivalent'.
Part 13 — Reagent for detection of HIV Ag/Att Combo applicable to immune analyser Architect i2000sr 'or equivalent'.
Part 14 — Reagent for detection of Syphilis (TP) applicable to immune analyser Architect i2000sr 'or equivalent'.
Part 23 — Rubber bottle caps for reagents applicable to immune analyser Architect i2000sr ‘or equivalent’.

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 imposed; and — a certificate that a misdemeanor sanction resulting in prohibition for practising profession 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.