Public procurement notice: Contract Notice
Published: 2016-06-25
Buyer: Institute of Transfusion Medicine
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33141530
Estimated value: 4500000 MKD
Submission deadline: 2016-07-06
Award criteria: Lowest price

Technical requirements: Automatic System for Polymerase Chain Reaction in Real Time (PCR) and Kit Reagents for Detection of at least 6 Types Thrombophilia Mutations (SNPS): Factor V (R506Q, H1299R, Y1702C), Factor II (G20210A) and MTHFR (C677T, A1298C).
Pho Institute of Transfusion Medicine of Republic of Macedonia — Skopje, located at Vodnjanska 17 St, Skopje.
Automatic System for Polymerase Chain Reaction in real Time (PCR) and Kit Reagents for Detection of at least 6 Types Thrombophilia Mutations (SNPS): Factor V (R506Q, H1299R, Y1702C), Factor II (G20210A) and MTHFR (C677T, A1298C).
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 excluded.
— DRD Form, issued by the Central Registry or relevant document issued by a competent authority in the country where the tenderer is registered; and
— A valid decision on performing for wholesale of medical drugs issued by the Agency for Medicines and Medical Devices (Article 126 paragraph 2 of 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 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;
— A certificate that a misdemeanour sanction resulting in prohibition for practising profession, performing activity or duty, i.e. temporary prohibition for performing a particular activity has not been imposed by a legally valid Court decision.
Decision on registration of medical devices — Reagents for Detection of at least 6 Types of Thrombophilia Mutations (SNPS): Factor V (R506Q, H1299R, Y1702C), Factor II (G20210A) and MTHFR (C677T, A1298C) in the Register of Medical Devices available in Republic of Macedonia or temporal approval i.e. Final approval for importing parallel medical device pursuant to Articles 131 and 131 of the Law on Medicines and Medical Devices issued by the Agency for Medicines and Medical Devices.
The subject of supply — Reagents for Detection of at least 6 Types of Thrombophilia Mutations (SNPS): Factor V (R506Q, H1299R, Y1702C), Factor II (G20210A) and MTHFR (C677T, A1298C) should be approved for release on the market in Republic of Macedonia according to the Law on Medicines and Medical Devices brought by the Agency for Medicines and Medical Devices.
Pho Institute of Transfusion Medicine of The Republic of Macedonia Skopje, located on Vodnjanska 17 St, Skopje — Meeting Hall.

Eligibility requirements: Document for registered activity: — DRD Form, issued by the Central Registry or relevant document issued by a competent authority in the country where the tenderer is registered; and — A valid decision on performing for wholesale of medical drugs issued by the Agency for Medicines and Medical Devices (Article 126 paragraph 2 of 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 imposed; — A certificate that a misdemeanour sanction resulting in prohibition for practising profession, performing activity or duty, i.e. temporary prohibition for performing a particular activity has not been imposed by a legally valid Court decision. Decision on registration of medical devices — Reagents for Detection of at least 6 Types of Thrombophilia Mutations (SNPS): Factor V (R506Q, H1299R, Y1702C), Factor II (G20210A) and MTHFR (C677T, A1298C) in the Register of Medical Devices available in Republic of Macedonia or temporal approval i.e. Final approval for importing parallel medical device pursuant to Articles 131 and 131 of the Law on Medicines and Medical Devices issued by the Agency for Medicines and Medical Devices. The subject of supply — Reagents for Detection of at least 6 Types of Thrombophilia Mutations (SNPS): Factor V (R506Q, H1299R, Y1702C), Factor II (G20210A) and MTHFR (C677T, A1298C) should be approved for release on the market in Republic of Macedonia according to the Law on Medicines and Medical Devices brought by the Agency for Medicines and Medical Devices.
Decision on registration of medical devices — Reagents for Detection of at least 6 Types of Thrombophilia Mutations (SNPS): Factor V (R506Q, H1299R, Y1702C), Factor II (G20210A) and MTHFR (C677T, A1298C) in the Register of Medical Devices available in Republic of Macedonia or temporal approval i.e. Final approval for importing parallel medical device pursuant to Articles 131 and 131 of the Law on Medicines and Medical Devices issued by the Agency for Medicines and Medical Devices. The subject of supply — Reagents for Detection of at least 6 Types of Thrombophilia Mutations (SNPS): Factor V (R506Q, H1299R, Y1702C), Factor II (G20210A) and MTHFR (C677T, A1298C) should be approved for release on the market in Republic of Macedonia according to the Law on Medicines and Medical Devices brought by the Agency for Medicines and Medical Devices.
Decision on registration of medical devices — Reagents for Detection of at least 6 Types of Thrombophilia Mutations (SNPS): Factor V (R506Q, H1299R, Y1702C), Factor II (G20210A) and MTHFR (C677T, A1298C) in the Register of Medical Devices available in Republic of Macedonia or temporal approval i.e. Final approval for importing parallel medical device pursuant to Articles 131 and 131 of the Law on Medicines and Medical Devices issued by the Agency for Medicines and Medical Devices.
The subject of supply — Reagents for Detection of at least 6 Types of Thrombophilia Mutations (SNPS): Factor V (R506Q, H1299R, Y1702C), Factor II (G20210A) and MTHFR (C677T, A1298C) should be approved for release on the market in Republic of Macedonia according to the Law on Medicines and Medical Devices brought by the Agency for Medicines and Medical Devices.