Public procurement notice: Contract Notice
Published: 2016-07-29
Buyer: Public Health Institute University Clinic for Clinical Biochemistry — Skopje
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33000000
Submission deadline: 2016-08-29

Technical requirements: Reagents, Controls and Suppliers for Immunological Analyzer Cobas E601 ‘or The Equivalent’ and Cobas Emira ‘or The Equivalent’.
Part 15 Universal control sample in determining at least Folic acid, Osteocalcin, PTH, Vitamin D, Vitamin B12 for Cobas e 601 ‘Or Equivalent’;
Part 22 Universal control sample for at least Cortizol, FT3, FT4, Total T3, Total T4 for Cobas e 601 ‘Or Equivalent’;
Part 29 Universal control for at least CEA, AFP, FT3, FT4, PSA, S100, Testosterone, T3, T4 Cobas e 601’ ‘Or Equivalent’;
Part 33 A means for preparing a measurement cell with min. volume of 2L for Cobas e 601 ‘Or Equivalent’ with stability in the machine for 5 days;
Part 34 A means for cleaning a measurement cell with min. volume of 2L for Cobas e 601 ‘Or Equivalent’ with stability in the machine for 5 days;
Part 35 A means for cleaning — solution to reduce interference in measurement for Cobas e 601 ‘Or Equivalent’ package with min. 500ml;
Part 37 Plastic tub for application cleaner for cleaning the reagent needle for Cobas е 601 ‘Or Equivalent’;
Part 38 Plastic tub for application of system reagents for preparation of the measuring cell for Cobas е 601 ‘Or Equivalent’;
Part 39 Consumables — earmarked tentacles for pipetting serum with volume of 5 μl-100 μl package with min. 500;
Part 40 A means for preparing the measuring cell package with min. volume of 380 ml for Cobas e 601 or equivalent with stability in the machine for 3 days;
Part 41 A means for cleaning the measuring cell for Cobas e 601 ‘Or Equivalent’ package with min. volume of 380ml with stability in the machine for 3 days;
Part 44 Reagent kit for the determination of angiotensin converting enzyme (ACE) a colorimetric kinetic method of Cobas Emira ‘Or Equivalent’;
Part 45 Plastic cuvettes for sample — serum with dimensions of minimum 17mmX38mm and volume 2ml applicative for Cobas е 601 ‘Or Equivalent’.
1. Solutions for calibration of highly sensitive Troponin T for Cobas e 601 ‘Or Equivalent’ with bottom limit ≤ 18 ng/L and top limit ≥ 4200 ng/L;

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 misdemeanour 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 appliances: — For the offered goods the economic operator shall have an Approval for putting into trade a medical appliance or Temporary or Permanent Approval for parallel import, according to the Law on Medicines and Medical Appliances. For unregistered medical appliances: — For the offered goods the economic operator shall have a document allowing import (An Approval for Interventional Import) according to the Law on Medicines and Medical Appliances. For registered medical appliances: — Approval for putting into trade a medical appliance or Temporary or Permanent Approval for parallel import, according to the Law on Medicines and Medical Appliances. For unregistered medical appliances: — Import License (Approval for Intervention Import) under the Law on Medicines and Medical Appliances.
For registered medical appliances: — For the offered goods the economic operator shall have an Approval for putting into trade a medical appliance or Temporary or Permanent Approval for parallel import, according to the Law on Medicines and Medical Appliances. For unregistered medical appliances: — For the offered goods the economic operator shall have a document allowing import (An Approval for Interventional Import) according to the Law on Medicines and Medical Appliances. For registered medical appliances: — Approval for putting into trade a medical appliance or Temporary or Permanent Approval for parallel import, according to the Law on Medicines and Medical Appliances. For unregistered medical appliances: — Import License (Approval for Intervention Import) under the Law on Medicines and Medical Appliances.
For registered medical appliances: — For the offered goods the economic operator shall have an Approval for putting into trade a medical appliance or Temporary or Permanent Approval for parallel import, according to the Law on Medicines and Medical Appliances. For unregistered medical appliances: — For the offered goods the economic operator shall have a document allowing import (An Approval for Interventional Import) according to the Law on Medicines and Medical Appliances.
For registered medical appliances: — Approval for putting into trade a medical appliance or Temporary or Permanent Approval for parallel import, according to the Law on Medicines and Medical Appliances. For unregistered medical appliances: — Import License (Approval for Intervention Import) under the Law on Medicines and Medical Appliances.