Public procurement notice: Contract Notice
Published: 2017-01-26
Buyer: Public Health Institute University Clinic for Clinical Biochemistry — Skopje
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33000000
Submission deadline: 2017-02-20

Technical requirements: Reagents, calibrators, controls and supplies imunoanalizator Architect I 1000 ‘or equivalent'’ and specific reagents in urine analyses.
LOT 1 Determining the concentration of CYCLOSPORINE in transplant patients for Architect i1000 “or equivalent”.
LOT 15 Determining concentration of TACROLIMUS for transplant patients for Architect i1000 "or equivalent".
LOT 20 Activation solution (polyethylene glycol octiphenyl ether and sodium hydroxide) for Architect i1000 ,,or equivalent" maximum 4L.
LOT 21 Re-activation solution (1.32 % hydrogen peroxide) for Architect i1000 ,,or equivalent" maximum 4L.
LOT 22 Plastic cups for samples min. height 48,87mm, opening with min. 7,55 mm diameter and conical bottom with min. diameter of 5.39 for Architect i1000 "or equivalent".
LOT 23 Reactive cells plastic with hole long min.14,4 wide min.7,04mm mm and high min.4,0mm, with height and width of the reaction cell min.39,8 mm and 10,5mm with conical bottom for Architect i1000 “or equivalent”.
LOT 25 Replacement plastic caps for reagent with an inner and an outer diameter of min. 30mm and 35,28mm for Architect i1000 “or equivalent".
LOT 27 Test kit for the determination of vanilla mandelic acid in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent", with a minimum of 20 tests in pack.
LOT 28 Test kit for the determination of metanefrin in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent", with a minimum of 40 tests in pack.
LOT 29 Test kit for the determination of 17 ketogenic steroids in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent".
LOT 30 Test kit for the determination of 17 hydroxycorticosteroids in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent".
LOT 31 Test kit for the determination of 5 hydroxy indolcent acid in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent".
LOT 1 Determining the concentration of cyclosporine in transplant patients for Architect i1000 ‘or equivalent’.
LOT 15 Determining concentration of tacrolimus for transplant patients for Architect i1000 ‘or equivalent’.

Eligibility requirements: A Document for registered activity– DRD Form or a Confirmation for registered activity: — Solution for wholesale of drugs under the Law on medicines and medical devices; — 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 impoused,and — a certificate that a misdemeanor sanction resulting in prohibition for practicing profession, performing activity or EN Standard form 02 — Contract notice 7 / 16 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 secured 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 non-registered medical devices: — The economic operator for the offered goods shall have a document allowing imports (approval for intervention import) under the Law on Medicines and Medical Devices. For registered medical devices: — Decision 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 non-registered medical devices: — Import License (approval for intervention import) under the Law on Medicines and Medical Devices.
For registered medical devices: — The economic operator for the offered goods shall have secured 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 non-registered medical devices: — The economic operator for the offered goods shall have a document allowing imports (approval for intervention import) under the Law on Medicines and Medical Devices. For registered medical devices: — Decision 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 non-registered medical devices: — Import License (approval for intervention import) under the Law on Medicines and Medical Devices.
For registered medical devices: — The economic operator for the offered goods shall have secured 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 non-registered medical devices: — The economic operator for the offered goods shall have a document allowing imports (approval for intervention import) under the Law on Medicines and Medical Devices.
For registered medical devices: — Decision 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 non-registered medical devices: — Import License (approval for intervention import) under the Law on Medicines and Medical Devices.