Public procurement notice: Contract Notice
Published: 2018-04-28
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33192330
Estimated value:  MKD
Submission deadline: 2018-06-05
Award criteria: Lowest price

Technical requirements: Pho Institute of Transfusion Medicine of Republic of Macedonia — Skopje, located at Vodnjanska 17 St.Skopje
1) System of fourfold blood bags with anticoagulant CPD and preservative SAG-Manitol with volume of 450 ml (+/- 5 %) with configuration of the system Top and Bottom;
2) System of fourfold blood bags with anticoagulant CPD and preservative SAG-Manitol with volume of 450 ml (+/- 5 %) with configuration of the system Top and Top;
With the offered bags the following equipment for Blood Processing and Blood Components need to be confirmed for free usage in the period of 2 years.
3) The economic operator is required to provide, without charge, an appropriate quantity of ACCESSORIES based on the bags technology, according to the number of bags for freely operation with them (pliers, rings, clamps or other additional materials necessary for safe closing of the gut of bags, blood squeezing, intestine cutting and so on).
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 exclude.
— 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 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 activity or duty, i.e. temporary prohibition for performing a particular activity has not been imposed by a legally valid court decision.
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 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.
The economic operator is obliged to train the medical personnel who will handle the equipment for blood processing and blood components allowed for usage by the Economic operator, who will issue an appropriate confirmation / certificate for training;

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 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. The economic operator is obliged to train the medical personnel who will handle the equipment for blood processing and blood components allowed for usage by the Economic operator, who will issue an appropriate confirmation / certificate for training; The economic operator is obliged to provide service and maintenance of the equipment for blood processing and blood components that it will allow for usage free of charge for a period of 2 (two) years. 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. —— A statement from the economic operator that will train the medical personnel who will handle the equipment for blood processing and blood components allowed for usage by the Economic Operator. EO will provide appropriate confirmation/ certificates to the medical staff attending the training. —— A statement from the economic operator that will provide service and maintenance of the equipment for blood processing and blood components that it will allow for usage free of charge for a period of 2 (two) years.
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. The economic operator is obliged to train the medical personnel who will handle the equipment for blood processing and blood components allowed for usage by the Economic operator, who will issue an appropriate confirmation / certificate for training; The economic operator is obliged to provide service and maintenance of the equipment for blood processing and blood components that it will allow for usage free of charge for a period of 2 (two) years. 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. —— A statement from the economic operator that will train the medical personnel who will handle the equipment for blood processing and blood components allowed for usage by the Economic Operator. EO will provide appropriate confirmation/ certificates to the medical staff attending the training. —— A statement from the economic operator that will provide service and maintenance of the equipment for blood processing and blood components that it will allow for usage free of charge for a period of 2 (two) years.
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. The economic operator is obliged to train the medical personnel who will handle the equipment for blood processing and blood components allowed for usage by the Economic operator, who will issue an appropriate confirmation / certificate for training; The economic operator is obliged to provide service and maintenance of the equipment for blood processing and blood components that it will allow for usage free of charge for a period of 2 (two) years.
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. —— A statement from the economic operator that will train the medical personnel who will handle the equipment for blood processing and blood components allowed for usage by the Economic Operator. EO will provide appropriate confirmation/ certificates to the medical staff attending the training. —— A statement from the economic operator that will provide service and maintenance of the equipment for blood processing and blood components that it will allow for usage free of charge for a period of 2 (two) years.