Public procurement notice: Contract Notice
Published: 2016-08-19
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33696200
Estimated value: 8500000 MKD
Submission deadline: 2016-09-29
Award criteria: Lowest price

Technical requirements: Pho Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at Vodnjanska 17 St, Skopje.
Part 1 — Set of reagents for molecular typing of HLA A-B-C alleles with included enzyme Taq polymerase applicative to Olerup SSP gel electrophoresis or equivalent and existing software for interpretation of results used in the laboratory Helmberg SCORE software or equivalent;
Part 2 — Set of reagents for molecular typing of HLA DQ-DR alleles with included enzyme Taq polymerase applicative to Olerup SSP gel electrophoresis or equivalent and existing software for interpretation of results used in the laboratory Helmberg SCORE software or equivalent;
Part 3 — Set of reagents for the detection of at least 13 autoimmune antibodies applicative to Tendigo apparatus or equivalent and existing software for interpretation of results InnoScore software or equivalent;
Part 4 — Set of reagents for isolation of genomic DNA from different samples applicative to apparatus Maxwell 16 system or equivalent;
Part 5 — Set of reagents for the detection of a mutation of F-V Laiden / F-II, MHTFR applicative to apparatus Tendigo or equivalent and existing software for interpretation of results InnoScore software or equivalent.
Set of reagents for molecular typing of HLA A-B-C alleles with included enzyme Taq polymerase applicative to Olerup SSP gel electrophoresis or equivalent and existing software for interpretation of results used in the laboratory Helmberg SCORE software or equivalent.
Set of reagents for molecular typing of HLA A-B-C alleles with included enzyme Taq polymerase applicative to Olerup SSP gel electrophoresis or equivalent and existing software for interpretation of results used in the laboratory Helmberg SCORE software or equivalent — Test 288.
Set of reagents for molecular typing of HLA DQ-DR alleles with included enzyme Taq polymerase applicative to Olerup SSP gel electrophoresis or equivalent and existing software for interpretation of results used in the laboratory Helmberg SCORE software or equivalent.
Set of reagents for molecular typing of HLA DQ-DR alleles with included enzyme Taq polymerase applicative to Olerup SSP gel electrophoresis or equivalent and existing software for interpretation of results used in the laboratory Helmberg SCORE software or equivalent — Test 288.
Set of reagents for the detection of at least 13 autoimmune antibodies applicative to Tendigo apparatus or equivalent and existing software for interpretation of results InnoScore software or equivalent.
Set of reagents for the detection of at least 13 autoimmune antibodies applicative to Tendigo apparatus or equivalent and existing software for interpretation of results InnoScore software or equivalent — Test 300.
Set of reagents for isolation of genomic DNA from different samples applicative to apparatus Maxwell 16 system or equivalent.
Set of reagents for isolation of genomic DNA from different samples applicative to apparatus Maxwell 16 system or equivalent — Test 960.
Set of reagents for the detection of a mutation of F-V Laiden / F-II, MHTFR applicative to apparatus Tendigo or equivalent and existing software for interpretation of results InnoScore software 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 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 devices: — The Economic operator for the offered goods shall have an Approval for placing the medical device on the market or temporary or permanent authorization for parallel imports, according to the Law on Medicines and Medical Devices, (for Part 1, Part 2, Part 3 and Part 5). For unregistered medical devices: — The Economic operator shall have a document allowing imports (Approval for Intervention Import) under the Law on Medicines and Medical Devices (Part 1, Part 2, Part 3 and Part 5). For registered medical devices: — Approval for placing the medical device on the market or temporary or permanent authorization for parallel imports, according to the Law on Medicines and Medical Devices (for Part 1, Part 2, Part 3 and Part 5). For unregistered medical devices: — Import Approval (Approval for Intervention Import) according to the Law on Medicines and Medical Devices (for Part 1, Part 2, Part 3 and Part 5).
For registered medical devices: — The Economic operator for the offered goods shall have an Approval for placing the medical device on the market or temporary or permanent authorization for parallel imports, according to the Law on Medicines and Medical Devices, (for Part 1, Part 2, Part 3 and Part 5). For unregistered medical devices: — The Economic operator shall have a document allowing imports (Approval for Intervention Import) under the Law on Medicines and Medical Devices (Part 1, Part 2, Part 3 and Part 5). For registered medical devices: — Approval for placing the medical device on the market or temporary or permanent authorization for parallel imports, according to the Law on Medicines and Medical Devices (for Part 1, Part 2, Part 3 and Part 5). For unregistered medical devices: — Import Approval (Approval for Intervention Import) according to the Law on Medicines and Medical Devices (for Part 1, Part 2, Part 3 and Part 5).
For registered medical devices: — The Economic operator for the offered goods shall have an Approval for placing the medical device on the market or temporary or permanent authorization for parallel imports, according to the Law on Medicines and Medical Devices, (for Part 1, Part 2, Part 3 and Part 5). For unregistered medical devices: — The Economic operator shall have a document allowing imports (Approval for Intervention Import) under the Law on Medicines and Medical Devices (Part 1, Part 2, Part 3 and Part 5).
For registered medical devices: — Approval for placing the medical device on the market or temporary or permanent authorization for parallel imports, according to the Law on Medicines and Medical Devices (for Part 1, Part 2, Part 3 and Part 5). For unregistered medical devices: — Import Approval (Approval for Intervention Import) according to the Law on Medicines and Medical Devices (for Part 1, Part 2, Part 3 and Part 5).