Public procurement notice: Contract Notice
Published: 2018-06-09
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33621000
Estimated value:  MKD
Submission deadline: 2018-06-19
Award criteria: Lowest price

Technical requirements: Pho Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at Vodnjanska 17 St., Skopje
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 include.
— 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.
— 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. (valid for item Nº 2 sets for collection of stem cells).
— 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. (valid for item Nº 2 sets for collection of stem cells).
— the economic operator is obliged to train the medical personnel who will handle with apparatus for collecting stem cells from the peripheral circulation for which they will issue an appropriate confirmation / certificate for training;
— the economic operator is obliged to provide service and maintenance of the apparatus for collection of stem cells from the peripheral circulation for free of charge during the warranty period at least 1 year.
— a Decision for marketing of medical device or temporary or permanent Authorization for parallel imports, under the Law on Medicines and medical devices. (valid for item Nº 2 sets for collection of stem cells).
— import License (Authorization for Intervention Import) under the Law on Medicines and medical devices (valid for item Nº 2 sets for collection of stem cells).

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. (valid for item Nº 2 sets for collection of stem cells). 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. (valid for item Nº 2 sets for collection of stem cells). — the economic operator is obliged to train the medical personnel who will handle with apparatus for collecting stem cells from the peripheral circulation for which they will issue an appropriate confirmation / certificate for training; — the economic operator is obliged to provide service and maintenance of the apparatus for collection of stem cells from the peripheral circulation for free of charge during the warranty period at least 1 year. 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. (valid for item Nº 2 sets for collection of stem cells). For unregistered medical supplies: — import License (Authorization for Intervention Import) under the Law on Medicines and medical devices (valid for item Nº 2 sets for collection of stem cells). — a statement from the economic operator that will train the medical personnel who will handle with apparatus for collecting stem cells from the peripheral circulation for which they will issue an appropriate confirmation / certificate of training; — a statement from the economic operator that will provide service and maintenance of the apparatus for collection of stem cells from the peripheral circulation for free of charge during the warranty period at least 1 year.
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. (valid for item Nº 2 sets for collection of stem cells). 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. (valid for item Nº 2 sets for collection of stem cells). — the economic operator is obliged to train the medical personnel who will handle with apparatus for collecting stem cells from the peripheral circulation for which they will issue an appropriate confirmation / certificate for training; — the economic operator is obliged to provide service and maintenance of the apparatus for collection of stem cells from the peripheral circulation for free of charge during the warranty period at least 1 year. 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. (valid for item Nº 2 sets for collection of stem cells). For unregistered medical supplies: — import License (Authorization for Intervention Import) under the Law on Medicines and medical devices (valid for item Nº 2 sets for collection of stem cells). — a statement from the economic operator that will train the medical personnel who will handle with apparatus for collecting stem cells from the peripheral circulation for which they will issue an appropriate confirmation / certificate of training; — a statement from the economic operator that will provide service and maintenance of the apparatus for collection of stem cells from the peripheral circulation for free of charge during the warranty period at least 1 year.
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. (valid for item Nº 2 sets for collection of stem cells). 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. (valid for item Nº 2 sets for collection of stem cells). — the economic operator is obliged to train the medical personnel who will handle with apparatus for collecting stem cells from the peripheral circulation for which they will issue an appropriate confirmation / certificate for training; — the economic operator is obliged to provide service and maintenance of the apparatus for collection of stem cells from the peripheral circulation for free of charge during the warranty period at least 1 year.
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. (valid for item Nº 2 sets for collection of stem cells). For unregistered medical supplies: — import License (Authorization for Intervention Import) under the Law on Medicines and medical devices (valid for item Nº 2 sets for collection of stem cells). — a statement from the economic operator that will train the medical personnel who will handle with apparatus for collecting stem cells from the peripheral circulation for which they will issue an appropriate confirmation / certificate of training; — a statement from the economic operator that will provide service and maintenance of the apparatus for collection of stem cells from the peripheral circulation for free of charge during the warranty period at least 1 year.