Public procurement notice: Contract Notice
Published: 2017-10-26
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33696200
Estimated value: 9000000 MKD
Submission deadline: 2017-12-04
Award criteria: Lowest price

Technical requirements: 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 detection of at least 6 types of Thrombosis mutations (SNPS): FACTOR V (R506Q, H1299R, Y1702C), FACTOR II (G20210A) and MTHFR (C677T, A1298C) applicative to apparatus Real Time PCR CFX96 system or the equivalent
PART 6- Set of reagents for the detection of at least the following polymorphisms: CYP2C9 geners1799853 (R144C, CYP2C9 * 2), rs1057910 (I359L, CYP2C9 * 3) CYP4F2 geners2108622 (V433M, CYP4F2 * 3) VKORC1 geners9923231 for pharmacological response to coumarin derivatives Applicable 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 — 48 tests.
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 — 48 tests.
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 — 500tests.
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 — 672 tests.
Set of reagents for detection of at least 6 types of Thrombosis mutations (SNPS): FACTOR V (R506Q, H1299R, Y1702C), FACTOR II (G20210A) and MTHFR (C677T, A1298C) applicative to apparatus Real Time PCR CFX96 system or the 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 inpoused and — a certificate that a misdemeanor sanction resulting in prohibition for practicing, 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.