Детали проекта

Общая информация

Название проекта

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

Contract notice
11 Фев 2019

Опубликован

11 Февраль 2019

Срок подачи

18 Март 2019

Бюджет

32 400 000 MKD


Тип тендера

Поставки

Номер

ECZ226038-Candidate countries

Донор

EC - Европейская комиссия (ЕК)

Лоты

LOT 1. Tape for Quantitative Determination of Prothrombin Time, Applicable to a Portable Coagulometer Xprecia Stride or Equivalent

LOT 2. Control Plasma for Checking the Prothrombin Time Applicative to a Portable Coagulometer Xprecia Stride or Equivalent


Страны

Северная Македония

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

2019/S 029-065848

Contract notice

Supplies

Legal Basis:

Directive 2014/24/EU

Section I: Contracting authority
I.1)Name and addresses
Institute of Transfusion Medicine
Vodnjanska 17
Skopje
1000
The former Yugoslav Republic of Macedonia
Contact person: Bobi Bozinovski
Telephone: +38 923226923
E-mail: transfuziologija@gmail.com
Fax: +38 923119227
NUTS code: MK0

Internet address(es):

Main address: www.itm.org.mk
I.2)Information about joint procurement
I.3)Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at: www.e-nabavki.gov.mk
Additional information can be obtained from the abovementioned address
Tenders or requests to participate must be submitted electronically via: www.e-nabavki.gov.mk
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at: www.e-nabavki.gov.mk
I.4)Type of the contracting authority
Other type: Institute of Transfusion Medicine
I.5)Main activity
Health

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

Consumable Material for Portable Coagulometer Xprecia Stride or Equivalent

Reference number: 03/2019
II.1.2)Main CPV code
33696200
II.1.3)Type of contract
Supplies
II.1.4)Short description:

Consumable material for portable coagulometer Xprecia Stride or equivalent according to technical specifications.

— part 1 — Tape for quantitative determination of Prothrombin time, applicable to a portable coagulometer Xprecia Stride or equivalent,

— part 2 — Control plasma for checking the prothrombin time applicative to a portable coagulometer Xprecia Stride or equivalent.

II.1.5)Estimated total value
Value excluding VAT: 32 400 000.00 MKD
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:

Tape for Quantitative Determination of Prothrombin Time, Applicable to a Portable Coagulometer Xprecia Stride or Equivalent

Lot No: 1
II.2.2)Additional CPV code(s)
33696200
II.2.3)Place of performance
NUTS code: MK
Main site or place of performance:

Institute of Transfusion Medicine of Republic of Macedonia — Skopje, located at St. Mother Tereza 17, Skopje.

II.2.4)Description of the procurement:

Tape for quantitative determination of Prothrombin time, applicable to a portable coagulometer Xprecia Stride or equivalent according to technical specification — 140 000 pieces.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
Value excluding VAT: 32 400 000.00 MKD
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in days: 365
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.2.12)Information about electronic catalogues
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:

Control Plasma for Checking the Prothrombin Time Applicative to a Portable Coagulometer Xprecia Stride or Equivalent

Lot No: 2
II.2.2)Additional CPV code(s)
33696200
II.2.3)Place of performance
NUTS code: MK
Main site or place of performance:

Institute of Transfusion Medicine of Republic of Macedonia — Skopje, located at St. Mother Tereza 17, Skopje.

II.2.4)Description of the procurement:

Control plasma for checking the prothrombin time applicative to a portable coagulometer Xprecia Stride or equivalent according to technical specification — 28 sets.

II.2.5)Award criteria
Criteria below
Price
II.2.6)Estimated value
Value excluding VAT: 32 400 000.00 MKD
II.2.7)Duration of the contract, framework agreement or dynamic purchasing system
Duration in days: 365
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.2.12)Information about electronic catalogues
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:

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 organisation, 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 and

— a certificate that a misdemeanour sanction resulting in prohibition for practising profession activity or duty, i.e.temporary prohibition for performing a particular activity has not been imposed by a legally valid court decision.

III.1.2)Economic and financial standing
III.1.3)Technical and professional ability
List and brief description of selection criteria:

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 Authorisation 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 authorises the import (Approval for intervention import) under the Law on Medicines and Medical Devices,

— the economic operator is obliged to provide an authorised service provider for maintenance of the coagulometers for which he will offer a bids for the consumable material, which will take care of calibration, service and maintenance of the devices for smooth operation of the coagulometers during the duration of use of its consumables without charge.

Minimum level(s) of standards possibly required:

For registered medical supplies:

— a Decision for marketing of medical device or temporary or permanent Authorisation for parallel imports, under the Law on Medicines and Medical Devices.

For unregistered medical supplies:

— Import License (Authorisation for Intervention Import) under the Law on Medicines and Medical Devices,

— Statement that the economic operator will provide an authorised service provider for maintenance of the coagulometers for which he will offer a bid for the consumable material, which will take care of calibration, service and maintenance of the coagulometers for the smooth operation of the coagulometers during the duration of the use of the consumable material without charge.

III.1.5)Information about reserved contracts
III.2)Conditions related to the contract
III.2.2)Contract performance conditions:
III.2.3)Information about staff responsible for the performance of the contract

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.1.4)Information about reduction of the number of solutions or tenders during negotiation or dialogue
IV.1.6)Information about electronic auction
An electronic auction will be used
Additional information about electronic auction:

All qualified contractors will be informed and invited for e-auction.

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.2.1)Previous publication concerning this procedure
IV.2.2)Time limit for receipt of tenders or requests to participate
Date: 18/03/2019
Local time: 11:00
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.2.6)Minimum time frame during which the tenderer must maintain the tender
Duration in months: 3 (from the date stated for receipt of tender)
IV.2.7)Conditions for opening of tenders
Date: 18/03/2019
Local time: 11:00
Place:

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

Information about authorised persons and opening procedure:

Any person mast 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 electronic workflows
VI.3)Additional information:
VI.4)Procedures for review
VI.4.1)Review body
State commission on public procurement
Bull. “Ilinden” 63A
Skopje
1000
The former Yugoslav Republic of Macedonia
Telephone: +389 23251251
E-mail: dkzjn@gov.mk
Fax: +389 23251250
VI.4.2)Body responsible for mediation procedures
VI.4.3)Review procedure
VI.4.4)Service from which information about the review procedure may be obtained
VI.5)Date of dispatch of this notice:
07/02/2019