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Supplies - 472266-2021

17/09/2021    S181

North Macedonia-Prilep: Medicinal products for the respiratory system

2021/S 181-472266

Contract notice

Supplies

Legal Basis:
Directive 2014/24/EU

Section I: Contracting authority

I.1)Name and addresses
Official name: JZU Centar za javno zdravje Prilep
Town: Prilep
NUTS code: MK0 Северна Македонија / Severna Makedonija
Country: North Macedonia
Contact person: Elena Miloskoska Bogoeska
E-mail: cjzprilep1@yahoo.com
Internet address(es):
Main address: https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/7237177d-8c5e-40c0-bf5e-46c4f5de7552/1
I.3)Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at: https://e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/7237177d-8c5e-40c0-bf5e-46c4f5de7552/1
Additional information can be obtained from the abovementioned address
Tenders or requests to participate must be submitted to the abovementioned address
I.4)Type of the contracting authority
Regional or local authority
I.5)Main activity
Health

Section II: Object

II.1)Scope of the procurement
II.1.1)Title:

TESTS, REAGENTS AND OTHER CONSUMABLE MATERIAL FOR PCR FOR DIAGNOSIS OF COVID 19

II.1.2)Main CPV code
33670000 Medicinal products for the respiratory system
II.1.3)Type of contract
Supplies
II.1.4)Short description:

TESTS, REAGENTS AND OTHER CONSUMABLE MATERIAL FOR PCR FOR DIAGNOSIS OF COVID 19

II.1.5)Estimated total value
II.1.6)Information about lots
This contract is divided into lots: yes
Tenders may be submitted for all lots
II.2)Description
II.2.1)Title:

Molecular multiplex kit in one step for detection of SARS-CoV-2 and SARS-like coronaviruses.

Lot No: 1
II.2.2)Additional CPV code(s)
33670000 Medicinal products for the respiratory system
II.2.3)Place of performance
NUTS code: MK Северна Македонија / Severna Makedonija
II.2.4)Description of the procurement:

Molecular multiplex kit in one step for detection of SARS-CoV-2 and SARS-like coronaviruses. The putty must be applicable to the following samples of human material: nasopharyngeal and oropharyngeal swab, bronchioalveolar lavage, endotracheal aspirate, nasopharyngeal aspirate, nasal canal aspiration and sputum. PCR - the mix must be pre-prepared in microtubes (with a volume of 0.2 ml) with paraffin. The kit must include: mineral oil to prevent evaporation during the amplification process, Taq / RT enzyme which serves for reverse transcription of RNA into complementary DNA in one step, RNA-IC (internal control) appropriate and compatible with the kit for automatic viral nucleic acid DNA / RNA extraction for ab Genix apparatus or equivalent, RT-PCR SARS CoV 2 buffer and positive control. The whale must have a CE certificate. The kit must include detection of the following genes: E gene, N gene and gene detection for SARS-like coronaviruses. The detection of the above genes is compatible with the following fluorescent dyes: FAM, HEX, ROX and Cy5. Analytical sensitivity should be a maximum of 10 copies / µl. The kit is applicable and compatible with a Real-Time PCR DTPrime instrument or equivalent with DTmaster software or equivalent for automatic interpretation of results. To have a CE IVD mark or equivalent, and to be registered as a medical device at the Agency for Drugs and Medical Devices of the Republic of Macedonia. Northern Macedonia

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 12
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Automatic viral nucleic acid extraction kit DNA / RNA for ab Genix apparatus or equivalent

Lot No: 2
II.2.2)Additional CPV code(s)
33670000 Medicinal products for the respiratory system
II.2.3)Place of performance
NUTS code: MK Северна Македонија / Severna Makedonija
II.2.4)Description of the procurement:

Automatic viral nucleic acid extraction kit DNA / RNA for ab Genix apparatus or equivalent

Kit for rapid automatic extraction of viral nucleic acid (DNA / RNA) with high yield and high quality from serum, plasma, nasopharyngeal swab and other types of samples in liquid state. The kit should contain pre-prepared plates, which contain in advance all the necessary reagents for the extraction process (magnetic particles, cell lysis reagent, purified reagents for isolated nucleic acid DNA / RNA, nucleic acid elution buffer, binding buffer ), without the need for additional sample preparation steps. The nucleic acid extraction process should be based on the principle of magnetic or paramagnetic particles. The whale should be able to extract nucleic acid from a maximum of 200 µl sample, and obtain a final eluate of a maximum of 80 µl. One plate to contain a minimum of 16 nucleic acid extraction positions for a minimum of 16 patients in one release. The kit should also contain plastic tips for the automatic pipers installed in the system, and they should be used for one use. The kit must be compatible with the abGenix automatic extraction instrument or equivalent. The whale should have its own specially created and validated protocol that is embedded in the instrument for automatic extraction. The validated protocol for the automatic nucleic acid extraction kit should have a maximum duration of 10 minutes. To have a CE IVD mark or equivalent, and to be registered as a medical device at the Agency for Drugs and Medical Devices of the Republic of Macedonia. Northern Macedonia.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 12
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
II.2)Description
II.2.1)Title:

A set of reagents for automatic extraction of viral nucleic acid DNA / RNA with high yield and high quality from serum, plasma, nasopharyngeal swab and other types of liquid samples

Lot No: 3
II.2.2)Additional CPV code(s)
33670000 Medicinal products for the respiratory system
II.2.3)Place of performance
NUTS code: MK Северна Македонија / Severna Makedonija
II.2.4)Description of the procurement:

A set of reagents for automatic extraction of viral nucleic acid DNA / RNA with high yield and high quality from serum, plasma, nasopharyngeal swab and other types of liquid samples. The kit should contain pre-prepared comics, which contain in advance all the necessary reagents for the extraction process (magnetic particles, cell lysis reagent, purified reagents for isolated nucleic acid DNA / RNA, nucleic acid elution buffer, buffer for ). The whale must include proteinase K in lyophilized form and an appropriate medium for its dissolution. The nucleic acid extraction process should be based on the principle of magnetic or paramagnetic particles. The whale should be able to extract nucleic acid from a maximum of 200 µl sample, and obtain a final eluate of a maximum of 80 µl. A comic book should contain a maximum of one extraction, and come with a comic book adapter with a maximum of 8 positions in one adapter. The kit should also contain plastic tips for the automatic pipers installed in the system, and they should be used for one use. The kit must be compatible with the abGenix automatic extraction instrument or equivalent. It is mandatory to have a created and validated protocol (which is pre-installed in the appropriate instrument for automated extraction with a maximum duration of 30 minutes). No special media and swabs required. To have a CE IVD mark or equivalent, and to be registered as a medical device at the Agency for Drugs and Medical Devices of the Republic of Macedonia. Northern Macedonia.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 12
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Sterile filter extensions

Lot No: 4
II.2.2)Additional CPV code(s)
33670000 Medicinal products for the respiratory system
II.2.3)Place of performance
NUTS code: MK Северна Македонија / Severna Makedonija
II.2.4)Description of the procurement:

Sterile filter extensions, with a volume of 10-200 microliters, packed in original boxes from the manufacturer.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 12
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Sterile filter extensions

Lot No: 5
II.2.2)Additional CPV code(s)
33670000 Medicinal products for the respiratory system
II.2.3)Place of performance
NUTS code: MK Северна Македонија / Severna Makedonija
II.2.4)Description of the procurement:

Sterile filter extensions, with a volume of 0.5-10 microliters with an extension length of 43-48 mm, packed in original boxes from the manufacturer.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 12
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information
II.2)Description
II.2.1)Title:

Polypropylene test tubes (Ependorf type)

Lot No: 6
II.2.2)Additional CPV code(s)
33670000 Medicinal products for the respiratory system
II.2.3)Place of performance
NUTS code: MK Северна Македонија / Severna Makedonija
II.2.4)Description of the procurement:

Polypropylene test tubes (Ependorf type) of 1.5ml with cap with writing part, resistant to low temperatures and in original packaging

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in months: 12
This contract is subject to renewal: no
II.2.10)Information about variants
Variants will be accepted: no
II.2.11)Information about options
Options: no
II.2.13)Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds: no
II.2.14)Additional information

Section III: Legal, economic, financial and technical information

III.1)Conditions for participation
III.1.1)Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers
List and brief description of conditions:

As in the tender documentation.

III.1.2)Economic and financial standing
List and brief description of selection criteria:

No.

III.1.3)Technical and professional ability
List and brief description of selection criteria:

As in the tender documentation.

Section IV: Procedure

IV.1)Description
IV.1.1)Type of procedure
Open procedure
IV.1.3)Information about a framework agreement or a dynamic purchasing system
IV.1.6)Information about electronic auction
An electronic auction will be used
IV.1.8)Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: no
IV.2)Administrative information
IV.2.2)Time limit for receipt of tenders or requests to participate
Date: 13/10/2021
Local time: 10:00
IV.2.3)Estimated date of dispatch of invitations to tender or to participate to selected candidates
IV.2.4)Languages in which tenders or requests to participate may be submitted:
Macedonian
IV.2.7)Conditions for opening of tenders
Date: 13/10/2021
Local time: 10:00
Place:

Prilep

Section VI: Complementary information

VI.1)Information about recurrence
This is a recurrent procurement: no
VI.2)Information about electronic workflows
Electronic ordering will be used
VI.3)Additional information:
VI.4)Procedures for review
VI.4.1)Review body
Official name: JZU Centar za javno zdravje Prilep
Town: Prilep
Country: North Macedonia
VI.5)Date of dispatch of this notice:
14/09/2021