Public procurement notice: Contract Notice
Published: 2018-02-23
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33621000
Estimated value:  MKD
Submission deadline: 2018-03-12
Award criteria: Lowest price

Technical requirements: Sets for the afternal acceleration of leukodeplated trimbocities for the trima accel appliance or the equivalent
Pho Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at Vodnjanska 17 St., Skopje
Sets for the afternal acceleration of leukodeplated trimbocities for the trima accel appliance or the equivalent
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 inpoused 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 obligated to provide an authorized service technician for maintenance of the appliance for which he will submit an offer for the sets, which will take care of maintenance and servicing of the appliance for the purpose of smooth operation of the appliance for the duration of use of its sets free of charge.
—— a Decision for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and Medical Devices.
—— Import License (Authorization for Intervention Import) under the Law on Medicines and Medical Devices,

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 inpoused 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 obligated to provide an authorized service technician for maintenance of the appliance for which he will submit an offer for the sets, which will take care of maintenance and servicing of the appliance for the purpose of smooth operation of the appliance for the duration of use of its sets free of charge. — 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, —— Statement that the economic operator will provide an authorized service technician for the maintenance of the appliance for which he will submit an offer for sets that he will take care of maintenance and servicing of the appliance for the purpose of smooth operation of the appliance for the duration of he use of its sets, free of charge.
— 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 obligated to provide an authorized service technician for maintenance of the appliance for which he will submit an offer for the sets, which will take care of maintenance and servicing of the appliance for the purpose of smooth operation of the appliance for the duration of use of its sets free of charge. — 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, —— Statement that the economic operator will provide an authorized service technician for the maintenance of the appliance for which he will submit an offer for sets that he will take care of maintenance and servicing of the appliance for the purpose of smooth operation of the appliance for the duration of he use of its sets, free of charge.
— 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 obligated to provide an authorized service technician for maintenance of the appliance for which he will submit an offer for the sets, which will take care of maintenance and servicing of the appliance for the purpose of smooth operation of the appliance for the duration of use of its sets free of charge.
— 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, —— Statement that the economic operator will provide an authorized service technician for the maintenance of the appliance for which he will submit an offer for sets that he will take care of maintenance and servicing of the appliance for the purpose of smooth operation of the appliance for the duration of he use of its sets, free of charge.