Public procurement notice: Contract Notice
Published: 2017-12-12
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33696200
Estimated value:  MKD
Submission deadline: 2018-01-15
Award criteria: Lowest price

Technical requirements: Reagents and medical supplies consumables for molecular typing for determining the HLA class I and class II antigens for determining antibodies using the xMAP technology and providing the necessary equipment.
With the offered reagents it is obligatory to submit the following equipment, that will be compatible with the offered tests, reagents and medical supplies and which will be given free of charge in the period of 1 year with the detailed technical characteristics given in the technical specifications.
A condition for signing a contract with the most favourable economic operator is to provide a bank guarantee by.
— a statement by the economic operator that it has not been imposed a legally valid court decision for.
— a certificate by a competent authority from the country where that economic operator is registered for paid.
— 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.
— a certificate by the Register of sentences for committed crimes of legal entities that a secondary sentence.
— a certificate that a misdemeanour sanction resulting in prohibition for practicing a 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 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.
— The Economic operator shall have a document allowing imports (Approval for Intervention Import) under the Law on Medicines and Medical Devices,
— The economic operator is obliged to provide service that will take care of calibration, service and maintenance of the equipment and for the smooth operation of the equipment in the duration of use of its reagents and supplies free of charge.
— 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.

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 misdemeanour sanction resulting in prohibition for practicing a 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 unregistered medical devices: — The Economic operator shall have a document allowing imports (Approval for Intervention Import) under the Law on Medicines and Medical Devices, — The economic operator is obliged to provide service that will take care of calibration, service and maintenance of the equipment and for the smooth operation of the equipment in the duration of use of its reagents and supplies free of charge. 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 unregistered medical devices: — Import Approval (Approval for Intervention Import) according to the Law on Medicines and Medical Devices, — A statement that the economic operator will provide service that will take care of calibration, service and maintenance of equipment for the smooth operation of the equipment in the duration of use of its reagents and supplies free of charge.
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 unregistered medical devices: — The Economic operator shall have a document allowing imports (Approval for Intervention Import) under the Law on Medicines and Medical Devices, — The economic operator is obliged to provide service that will take care of calibration, service and maintenance of the equipment and for the smooth operation of the equipment in the duration of use of its reagents and supplies free of charge. 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 unregistered medical devices: — Import Approval (Approval for Intervention Import) according to the Law on Medicines and Medical Devices, — A statement that the economic operator will provide service that will take care of calibration, service and maintenance of equipment for the smooth operation of the equipment in the duration of use of its reagents and supplies free of charge.
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 unregistered medical devices: — The Economic operator shall have a document allowing imports (Approval for Intervention Import) under the Law on Medicines and Medical Devices, — The economic operator is obliged to provide service that will take care of calibration, service and maintenance of the equipment and for the smooth operation of the equipment in the duration of use of its reagents and supplies free of charge.
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 unregistered medical devices: — Import Approval (Approval for Intervention Import) according to the Law on Medicines and Medical Devices, — A statement that the economic operator will provide service that will take care of calibration, service and maintenance of equipment for the smooth operation of the equipment in the duration of use of its reagents and supplies free of charge.