(MK) Nabavka reagensa za mikrobiološku kontrolu sterilnosti krvi i krvnih pripravaka za Bact/ lert 3D60 ili ekvivalent

Datum objave: 28.07.2017. 09:50 / Izvor: Official Journal of the European Union, 28.07.2017.

Former Yugoslav Republic of Macedonia-Skopje: Blood-testing reagents

2017/S 143-296254

Contract notice

Supplies

Directive 2004/18/EC

Section I: Contracting authority

I.1)Name, addresses and contact point(s)

Institute of Transfusion Medicine
Vodnjanska 17
1000 Skopje
The former Yugoslav Republic of Macedonia
Telephone: +38 923226923
E-mail: transfuziologija@gmail.com
Fax: +38 923119227

Further information can be obtained from: The above mentioned contact point(s)

Specifications and additional documents (including documents for competitive dialogue and a dynamic purchasing system) can be obtained from: The above mentioned contact point(s)

Tenders or requests to participate must be sent to: The above mentioned contact point(s)

I.2)Type of the contracting authority

Other: Institute of Transfusion Medicine
 

I.3)Main activity

Other: health
 

I.4)Contract award on behalf of other contracting authorities

The contracting authority is purchasing on behalf of other contracting authorities: no
 

Section II: Object of the contract

II.1)Description

II.1.1)Title attributed to the contract by the contracting authority:

Reagents for microbiological blood and blood products sterility control applicative for Bact/Alert 3D60 or the equivalent.
 

II.1.2)Type of contract and location of works, place of delivery or of performance

Supplies
Purchase

Main site or location of works, place of delivery or of performance: Pho Institute of Trasfusion Medicine of Republic of Macedonia — Skopje, located at Vodnjanska 17 St., Skopje.
NUTS code 

 

II.1.3)Information about a public contract, a framework agreement or a dynamic purchasing system (DPS)

The notice involves a public contract
 

II.1.4)Information on framework agreement

II.1.5)Short description of the contract or purchase(s)

PART 1Bottles of unbreakable plastic with nutritive reagent for detection of anaerobic and facultative anaerobic microorganisms ( bacteria and fungi) applicative for Bact/Alert 3D60 or the equivalent
PART 2 Bottles of unbreakable plastic with nutritive reagent for detection of aerobic microorganisms ( bacteria and fungi) applicative for Bact/Alert 3D60 or the equivalent.

 

II.1.6)Common procurement vocabulary (CPV)

33696200

II.1.7)Information about Government Procurement Agreement (GPA)

II.1.8)Lots

This contract is divided into lots: yes
Tenders may be submitted for one or more lots

 

II.1.9)Information about variants

Variants will be accepted: no
 

II.2)Quantity or scope of the contract

II.2.1)Total quantity or scope:

Estimated value excluding VAT: 5 000 000 MKD
 

II.2.2)Information about options

Options: no
 

II.2.3)Information about renewals

This contract is subject to renewal: no
 

II.3)Duration of the contract or time limit for completion

in days: 365 (from the award of the contract)
 

Information about lots

Lot No: 1 Lot title: Bottles of unbreakable plastic with nutritive reagent for detection of anaerobic and facultative anaerobic microorganisms ( bacteria and fungi) applicative for Bact/Alert 3D60 or the equivalent

1)Short description

Bottles of unbreakable plastic with nutritive reagent for detection of anaerobic and facultative anaerobic microorganisms ( bacteria and fungi) applicative for Bact/Alert 3D60 or the equivalent.
— Offered reagents to be applicative for for Bact/Alert 3D60 or the equivalent.

— Reagents should be sucha as there is no need for purchase of additional controls, calibrators, diluents or other consumables for test preparation.

 

2)Common procurement vocabulary (CPV)

33696200

3)Quantity or scope

Bottles of unbreakable plastic with nutritive reagent for detection of anaerobic and facultative anaerobic microorganisms ( bacteria and fungi) applicative for Bact/Alert 3D60 or the equivalent -2100 tests.
 

4)Indication about different date for duration of contract or starting/completion

5)Additional information about lots

Lot No: 2 Lot title: Bottles of unbreakable plastic with nutritive reagent for detection of aerobic microorganisms ( bacteria and fungi) applicative for Bact/Alert 3D60 or the equivalent

1)Short description

Bottles of unbreakable plastic with nutritive reagent for detection of aerobic microorganisms ( bacteria and fungi) applicative for Bact/Alert 3D60 or the equivalent.
 

2)Common procurement vocabulary (CPV)

33696200

3)Quantity or scope

Bottles of unbreakable plastic with nutritive reagent for detection of aerobic microorganisms ( bacteria and fungi) applicative for Bact/Alert 3D60 or the equivalent — 2 100tests.
— Offered reagents to be applicative for for Bact/Alert 3D60 or the equivalent.

— Reagents should be sucha as there is no need for purchase of additional controls, calibrators, diluents or other consumables for test preparation.

 

4)Indication about different date for duration of contract or starting/completion

5)Additional information about lots

Section III: Legal, economic, financial and technical information

III.1)Conditions relating to the contract

III.1.1)Deposits and guarantees required:

Guarantee for quality execution of the contract: A condition for signing a contract with the most favourable economic operator is to provide a bank guaranteeby the tenderer who is selected as the most favourable as well as for implementation of the contract in a qualitymanner in amount of 5 % of the value of the contract,VAT excluded.
 

III.1.2)Main financing conditions and payment arrangements and/or reference to the relevant provisions governing them:

III.1.3)Legal form to be taken by the group of economic operators to whom the contract is to be awarded:

III.1.4)Other particular conditions

III.2)Conditions for participation

III.2.1)Personal situation of economic operators, including requirements relating to enrolment on professional or trade registers

Information and formalities necessary for evaluating if the requirements are met: — 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 profesion performing activity or duty, i.e. temporary prohibition for performing a particular activ has not been imposed by a legally valid court decision.

 

III.2.2)Economic and financial ability

III.2.3)Technical capacity

Information and formalities necessary for evaluating if the requirements are met:
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.
Minimum level(s) of standards possibly required:
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.

 

III.2.4)Information about reserved contracts

III.3)Conditions specific to services contracts

III.3.1)Information about a particular profession

III.3.2)Staff responsible for the execution of the service

Section IV: Procedure

IV.1)Type of procedure

IV.1.1)Type of procedure

Open
 

IV.1.2)Limitations on the number of operators who will be invited to tender or to participate

IV.1.3)Reduction of the number of operators during the negotiation or dialogue

IV.2)Award criteria

IV.2.1)Award criteria

Lowest price
 

IV.2.2)Information about electronic auction

An electronic auction will be used: yes
Additional information about electronic auction: Qualified contractors will be informed and invited for e auction.

 

IV.3)Administrative information

IV.3.1)File reference number attributed by the contracting authority:

17/2017
 

IV.3.2)Previous publication(s) concerning the same contract

no
 

IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document

Time limit for receipt of requests for documents or for accessing documents: 8.8.2017 - 11:00
Payable documents: no

 

IV.3.4)Time limit for receipt of tenders or requests to participate

8.8.2017 - 11:00
 

IV.3.5)Date of dispatch of invitations to tender or to participate to selected candidates

IV.3.6)Language(s) in which tenders or requests to participate may be drawn up

Other: Macedonian.
 

IV.3.7)Minimum time frame during which the tenderer must maintain the tender

in days: 90 (from the date stated for receipt of tender)
 

IV.3.8)Conditions for opening of tenders

Date: 8.8.2017 - 11:00
 

Place:

Pho Institute of Transfusion Medicine of The Republic of Macedonia Skopje, located on Vodnjanska 17 St.,Skopje — Meeting Hall

Persons authorised to be present at the opening of tenders: yes
Additional information about authorised persons and opening procedure: Persons who want to be present at the opening of tenders must have authorisation letter from his/her economic operator.

 

Section VI: Complementary information

VI.1)Information about recurrence

This is a recurrent procurement: no
 

VI.2)Information about European Union funds

The contract is related to a project and/or programme financed by European Union funds: no
 

VI.3)Additional information

VI.4)Procedures for appeal

VI.4.1)Body responsible for appeal procedures

State commission on public procurement
Bull.‘Ilinden’ 63A
1000 Skopje
The former Yugoslav Republic of Macedonia
E-mail: dkzjn@gs.gov .mk
Telephone: +389 23251251
Fax: +389 23251250

VI.4.2)Lodging of appeals

VI.4.3)Service from which information about the lodging of appeals may be obtained

VI.5)Date of dispatch of this notice:

25.7.2017

 

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