Public procurement notice: Contract Notice
Published: 2016-05-18
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33696000
Estimated value: 7000000 MKD
Submission deadline: 2016-06-01
Award criteria: Lowest price

Technical requirements: Tests for quantitative determination of prothrombin time in capillary blood with assignment of the necessary equipment for free use for the period 1 year.
Pho Institute of Transfusion Medicine of Republic of Macedonia — Skopje, located at Vodnjanska 17 St., Skopje.
Tests for quantitative determination of prothrombin time in capillary blood with assignment of the necessary equipment for free use for the period 1 year.
Guarantee for quality execution of the contract: A condition for signing a contract with the most favourable economic operator is to provide a bank guarantee by the tenderer who is selected as the most favourable as well as for implementation of the contract in a quality manner in amount of 5 % of the value of the contract, VAT excluded.
— Document for registered activity — DRD Form, issued by the Central Registry or relevant document issued by a competent authority in the country where the tenderer is registered, and
— A valid decision on performing for wholesale of medical devices issued by the Agency for Medicines and Medical Devices (Article 126 paragraph 2 of 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 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.
— The subject of supply — Tests for quantitative determination of the prothrombin time in capillary blood should be approved for marketing in the Republic of Macedonia according to the Law on Medicines and Medical Devices by the Agency for drugs and medical devices.
Decision on registration of medical devices — Tests for quantitative determination of the prothrombin time in capillary blood, in the Registry of Medical Devices available in the country or -Temporary approval or final approval for parallel import of the medical means pursuant to Articles 131 and 131 and the Law on Medicines and Medical Devices issued by the Agency for Medicines and Medical Devices.
Additional information about electronic auction: All qualified contractors will be informed and invited for e-auction.
Pho Institute of Transfusion Medicine of The Republic Of Macedonia Skopje, located on Vodnjanska 17 St., Skopje — Meeting Hall.

Eligibility requirements: — Document for registered activity — DRD Form, issued by the Central Registry or relevant document issued by a competent authority in the country where the tenderer is registered, and — A valid decision on performing for wholesale of medical devices issued by the Agency for Medicines and Medical Devices (Article 126 paragraph 2 of 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 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. — The subject of supply — Tests for quantitative determination of the prothrombin time in capillary blood should be approved for marketing in the Republic of Macedonia according to the Law on Medicines and Medical Devices by the Agency for drugs and medical devices. Decision on registration of medical devices — Tests for quantitative determination of the prothrombin time in capillary blood, in the Registry of Medical Devices available in the country or -Temporary approval or final approval for parallel import of the medical means pursuant to Articles 131 and 131 and the Law on Medicines and Medical Devices issued by the Agency for Medicines and Medical Devices.
— The subject of supply — Tests for quantitative determination of the prothrombin time in capillary blood should be approved for marketing in the Republic of Macedonia according to the Law on Medicines and Medical Devices by the Agency for drugs and medical devices. Decision on registration of medical devices — Tests for quantitative determination of the prothrombin time in capillary blood, in the Registry of Medical Devices available in the country or -Temporary approval or final approval for parallel import of the medical means pursuant to Articles 131 and 131 and the Law on Medicines and Medical Devices issued by the Agency for Medicines and Medical Devices.
— The subject of supply — Tests for quantitative determination of the prothrombin time in capillary blood should be approved for marketing in the Republic of Macedonia according to the Law on Medicines and Medical Devices by the Agency for drugs and medical devices.
Decision on registration of medical devices — Tests for quantitative determination of the prothrombin time in capillary blood, in the Registry of Medical Devices available in the country or -Temporary approval or final approval for parallel import of the medical means pursuant to Articles 131 and 131 and the Law on Medicines and Medical Devices issued by the Agency for Medicines and Medical Devices.