Public procurement notice: Contract Notice
Published: 2018-07-26
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33696200
Estimated value:  MKD
Submission deadline: 2018-09-03
Award criteria: Lowest price

Technical requirements: Pho Institute of Transfusion Medicine of Republic of Macedonia — Skopje, located at Vodnjanska 17 St., Skopje
Part 2: Gel micro cards for set of interactions with monoclonal ABO/RhD confirmation and AHG testing;
Part 4: Modified Bromelin solution for stabilized enzyme activity for preparation of suspensions from erythrocytes for blood grouping and enzyme testing, max 500 ml;
Part 5: Modified solution with a low iodine strength (LISS)for preparation of 5% suspensions from erythrocytes for blood grouping and enzyme testing, max 500 ml;
Part 6: Cell-reagent set for screening of antibodies in patents (I-II), set of 2 vials for IAT and Na Cl test;
Part 7: Cell reagent for screening of antibodies in blood donors (I-II), 2 pooled erythrocyte suspensions;
Part 8: Cell reagents for detection of presence or lack of anti-A and anti-B iso agglutinin in reversible grouping, A1-B;
Part 11: Gel micro cards to determine the Du test, direct AHG test (DAT) and screening of antibodies, anti-IgG;
Part 12: Cell reagents containing cells appropriately selected to make sure the double presence of the significant blood group anti genes for identification of antibodies for IAT and Na CL test;
Part 13: Cell reagents providing identification of most anti genes and a mix of antigens in the Rh system for identification od anti bodies for enzyme testing, papainised;
Part 14: Cell reagents for 6 erythrocyte suspensions for screening of antibodies for IAT and enzyme test, papainised;
Part 19: Means for decontamination based on benzalkonium chloride and tetra-anhydride EDTA (alkyldimethyl / ethyl / benzyl / ammonium chloride, tetrasodiumethylenediamine tetraacetate);
Part 22: Microplates for dry reagent from mono clonal antibodies foer determining RH fenotype and K antigen;
Part 23: Cell reagent, 0,8% suspension for the determination of ABO antibodies to microwaves (set A1, B);
Part 25: Test for typing of known partial D phenotypes, differentiation of weak D types of partial D;

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 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