Public procurement notice: Contract Notice
Published: 2024-03-12
Region: MK008
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33100000
Submission deadline: 2024-03-22
Award criteria: price

Technical requirements: Procurement of Enzyme Hemiluminescence Tests (CLIA method)
— statement by the economic operator than it has not been sentenced, in the last 5 years, with effective court decision for participation in criminal organization, corruption, fraud or money laundering under Article 88 Paragraph 1 from the Law on Public procurement, 
— certificate that it is not subject to bankruptcy procedure issued by competent authority, 
— certificate that it is not subject to liquidation procedure issued by competent authority,
 — certificate for paid taxes, contributions and other public duties by the competent authority in the country where that economic operator is established,
 — certificate from the legal entities penal registry that it is not being imposed a side sanction — prohibition to participate in public competitions, public procurement contract award and public-private partnership contract award procedures, 
— certificate from the legal entities penal registry that it is not being imposed a side sanction — temporary or permanent prohibition to perform certain professional activity, 
— certificate that it is not being sanctioned for misdemeanor with an effective court decision, resulting in prohibition for pursuing professional activity or duty, i.e. temporary prohibition for performing certain activity
Certificate of registered activity (form BPD) as proof that he is registered as a natural or legal person for carrying out the activity related to the subject of the public procurement contract or proof that he belongs to an appropriate professional association in accordance with the regulations of the country where he is registered. In the Republic of North Macedonia the competent authority for the issuance of this document is the Central Register of the Republic of North Macedonia
 — copy (true to the original medicines wholesale/distribution authorization in the territory of the Republic of Macedonia issued by the Ministry of Health under the law on medicines and medical devices.
— document certified by the manufacturer (Original authorization from the manufacturer) of the requested procurement object that the economic operator has authorization and is allowed to apply for participation in the tender procedure, — reference list - list of deliveries made in the last year of the tests that are subject to procurement, — certificate of completed deliveries issued by at least three recipients of the reference list of activity of trade in drugs and medical devices, — reference list of the manufacturer of tests / reagents with minimum 3 references in Europe where the same tests are subject to procurement and delivery, — list of users of offered tests / reagents and / or apparatus in the EU issued and certified by the economic operator, — confirmation from the manufacturer of the device that the tests / reagents have a certificate for use of the appropriate device, — statement that the economic operator will provide authorized service for the device that will be available 24/7 and will take care of calibration, service and maintenance of the devices for smooth operation during the use of its reagents without compensation, — statement that the Quantities for the Consumables for work are sufficient for the smooth performance of all required analyzes that are detailed in the specification with quantities. If the offered quantities of consumables are not sufficient for smooth execution of the analyzes, the bidder will bear all costs that arose from the inability to perform the overall analyzes, ie they will provide the necessary materials free of charge, — IT IS MANDATORY TO BE MARKED. MACEDONIAN LANGUAGE TRANSLATION MUST BE SUBMITTED FOR THE BASIC CHARACTERISTICS OF REAGENTS AND PROCEDURES for those involved, with included material safety sheet (MSDS)for the offered reagents. ON THE BASIS OF THAT, IT WILL BE DETERMINED WHETHER THE OFFERED REAGENTS MEET THE REQUIREMENTS FROM THE TECHNICAL SPECIFICATION, — statement that the offered reagents correspond (are equivalent) to the existing equipment (Architekt instrument - Architect i-1000) — statement from the economic operator that the goods to be delivered will have a shelf life of at least 6 months from the day of delivery of the subject of procurement, — the reagents are for in vitro diagnostics and have CE certificate or equivalent
54 'Tests for determination of immunoglobulin M antibodies for rubella (RUBELLA IgM)