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Reagents, calibrators, controls and supplies imunoanalizator Architect I 1000 ‘or equivalent'’ and specific reagents in urine analyses

  Skopje Macedonia — Public Health Institute University Clinic for Clinical Biochemistry — Skopje
Published January 26, 2017 — Deadline February 20, 2017 (2 years ago)
|
Notice type
Contract notice

LOT 1 Determining the concentration of CYCLOSPORINE in transplant patients for Architect i1000 “or equivalent”.

LOT 2 Tumor marker Total BHCG for Architect i1000 “or equivalent".

LOT 3 Tumor marker CA 125 for Architect i1000 “or equivalent".

LOT 4 Determining the concentration of HOMOCYSTEINE for Architect i1000 "or equivalent".

LOT 5 Virus marker HBe antigen for Architect i1000 “or equivalent”.

LOT 6 Virus marker HBsAg antigen for Architect i1000 “or equivalent”.

LOT 7 Virus marker AntiHBs for Architect i1000 “or equivalent”.

LOT 8 Virus marker Anti-HBe for Architect i1000 “or equivalent”.

LOT 9 Virus marker Anti-HBc for Architect i1000 “or equivalent”.

LOT 10 Virus marker Anti-HCV for Architect i1000 “or equivalent”.

LOT 11 Virus marker HAVAB for Architect i1000 “or equivalent”.

LOT 12 Virus marker HAVAB-M for Architect i1000 “or equivalent”.

LOT 13 Cardiac marker highly sensitive TROPONIN I, for Architect i1000, “or equivalent”.

LOT 14 Virus marker HIV COMBO for Architect i1000 “or equivalent”.

LOT 15 Determining concentration of TACROLIMUS for transplant patients for Architect i1000 "or equivalent".

LOT 16 Tumor marker SCC for Architect i1000 “or equivalent".

LOT 17 Virus marker ANTI HBC M for Architect i1000 “or equivalent”.

LOT 18 Concentrated washing buffer for Architect i1000 “or equivalent,, maximum 4L.

LOT 19 Agent for conditioning the needle for sampling for Architect i1000 “or equivalent”.

LOT 20 Activation solution (polyethylene glycol octiphenyl ether and sodium hydroxide) for Architect i1000 ,,or equivalent" maximum 4L.

LOT 21 Re-activation solution (1.32 % hydrogen peroxide) for Architect i1000 ,,or equivalent" maximum 4L.

LOT 22 Plastic cups for samples min. height 48,87mm, opening with min. 7,55 mm diameter and conical bottom with min. diameter of 5.39 for Architect i1000 "or equivalent".

LOT 23 Reactive cells plastic with hole long min.14,4 wide min.7,04mm mm and high min.4,0mm, with height and width of the reaction cell min.39,8 mm and 10,5mm with conical bottom for Architect i1000 “or equivalent”.

LOT 24 Rubber caps for reagent for Architect i1000, “or equivalent”.

LOT 25 Replacement plastic caps for reagent with an inner and an outer diameter of min. 30mm and 35,28mm for Architect i1000 “or equivalent".

LOT 26 Tumor marker HE4 for Architect i1000 “or equivalent".

LOT 27 Test kit for the determination of vanilla mandelic acid in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent", with a minimum of 20 tests in pack.

LOT 28 Test kit for the determination of metanefrin in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent", with a minimum of 40 tests in pack.

LOT 29 Test kit for the determination of 17 ketogenic steroids in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent".

LOT 30 Test kit for the determination of 17 hydroxycorticosteroids in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent".

LOT 31 Test kit for the determination of 5 hydroxy indolcent acid in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent".


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Fact Sheet


Former Yugoslav Republic of Macedonia-Skopje: Medical equipments, pharmaceuticals and personal care products

2017/S 018-030891

Contract notice

Supplies

Directive 2004/18/EC

Section I: Contracting authority

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

Public Health Institute University Clinic for Clinical Biochemistry — Skopje
Vodnjanska 17
1000 Skopje
The former Yugoslav Republic of Macedonia
Telephone: +389 23125370
E-mail: jzuklinickabiohemija@gmail.com

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: Health Institute University Clinic for Clinikal Biochemistry
I.3)Main activity
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, calibrators, controls and supplies imunoanalizator Architect I 1000 ‘or equivalent'’ and specific reagents in urine analyses.
II.1.2)Type of contract and location of works, place of delivery or of performance
Supplies
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)
LOT 1 Determining the concentration of CYCLOSPORINE in transplant patients for Architect i1000 “or equivalent”.
LOT 2 Tumor marker Total BHCG for Architect i1000 “or equivalent".
LOT 3 Tumor marker CA 125 for Architect i1000 “or equivalent".
LOT 4 Determining the concentration of HOMOCYSTEINE for Architect i1000 "or equivalent".
LOT 5 Virus marker HBe antigen for Architect i1000 “or equivalent”.
LOT 6 Virus marker HBsAg antigen for Architect i1000 “or equivalent”.
LOT 7 Virus marker AntiHBs for Architect i1000 “or equivalent”.
LOT 8 Virus marker Anti-HBe for Architect i1000 “or equivalent”.
LOT 9 Virus marker Anti-HBc for Architect i1000 “or equivalent”.
LOT 10 Virus marker Anti-HCV for Architect i1000 “or equivalent”.
LOT 11 Virus marker HAVAB for Architect i1000 “or equivalent”.
LOT 12 Virus marker HAVAB-M for Architect i1000 “or equivalent”.
LOT 13 Cardiac marker highly sensitive TROPONIN I, for Architect i1000, “or equivalent”.
LOT 14 Virus marker HIV COMBO for Architect i1000 “or equivalent”.
LOT 15 Determining concentration of TACROLIMUS for transplant patients for Architect i1000 "or equivalent".
LOT 16 Tumor marker SCC for Architect i1000 “or equivalent".
LOT 17 Virus marker ANTI HBC M for Architect i1000 “or equivalent”.
LOT 18 Concentrated washing buffer for Architect i1000 “or equivalent,, maximum 4L.
LOT 19 Agent for conditioning the needle for sampling for Architect i1000 “or equivalent”.
LOT 20 Activation solution (polyethylene glycol octiphenyl ether and sodium hydroxide) for Architect i1000 ,,or equivalent" maximum 4L.
LOT 21 Re-activation solution (1.32 % hydrogen peroxide) for Architect i1000 ,,or equivalent" maximum 4L.
LOT 22 Plastic cups for samples min. height 48,87mm, opening with min. 7,55 mm diameter and conical bottom with min. diameter of 5.39 for Architect i1000 "or equivalent".
LOT 23 Reactive cells plastic with hole long min.14,4 wide min.7,04mm mm and high min.4,0mm, with height and width of the reaction cell min.39,8 mm and 10,5mm with conical bottom for Architect i1000 “or equivalent”.
LOT 24 Rubber caps for reagent for Architect i1000, “or equivalent”.
LOT 25 Replacement plastic caps for reagent with an inner and an outer diameter of min. 30mm and 35,28mm for Architect i1000 “or equivalent".
LOT 26 Tumor marker HE4 for Architect i1000 “or equivalent".
LOT 27 Test kit for the determination of vanilla mandelic acid in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent", with a minimum of 20 tests in pack.
LOT 28 Test kit for the determination of metanefrin in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent", with a minimum of 40 tests in pack.
LOT 29 Test kit for the determination of 17 ketogenic steroids in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent".
LOT 30 Test kit for the determination of 17 hydroxycorticosteroids in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent".
LOT 31 Test kit for the determination of 5 hydroxy indolcent acid in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 "or equivalent".
II.1.6)Common procurement vocabulary (CPV)

33000000

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:
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

Information about lots

Lot No: 1 Lot title: LOT 1 Determining the concentration of cyclosporine in transplant patients for Architect i1000 ‘or equivalent’
1)Short description
LOT 1 Determining the concentration of cyclosporine in transplant patients for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 2 Lot title: LOT 2 Tumor marker Total BHCG for Architect i1000 ‘or equivalent’
1)Short description
LOT 2 Tumor marker Total BHCG for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 3 Lot title: LOT 3 Tumor marker CA 125 for Architect i1000 ‘or equivalent’
1)Short description
LOT 3 Tumor marker CA 125 for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 4 Lot title: LOT 4 Determining the concentration of homocysteine for Architect i1000 ‘or equivalent’
1)Short description
LOT 4 Determining the concentration of homocysteine for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 5 Lot title: LOT 5 Virus marker HBe antigen for Architect i1000 ‘or equivalent’
1)Short description
LOT 5 Virus marker HBe antigen for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 6 Lot title: LOT 6 Virus marker HBsAg antigen for Architect i1000 ‘or equivalent’
1)Short description
LOT 6 Virus marker HBsAg antigen for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 7 Lot title: LOT 7 Virus marker AntiHBs for Architect i1000 ‘or equivalent’
1)Short description
LOT 7 Virus marker AntiHBs for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 8 Lot title: LOT 8 Virus marker Anti-HBe for Architect i1000 ‘or equivalent’
1)Short description
LOT 8 Virus marker Anti-HBe for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 9 Lot title: LOT 9 Virus marker Anti-HBc for Architect i1000 ‘or equivalent’
1)Short description
LOT 9 Virus marker Anti-HBc for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 10 Lot title: LOT 10 Virus marker Anti-HCV for Architect i1000 ‘or equivalent’
1)Short description
LOT 10 Virus marker Anti-HCV for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 11 Lot title: LOT 11 Virus marker HAVAB for Architect i1000 ‘or equivalent’
1)Short description
LOT 11 Virus marker HAVAB for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 12 Lot title: LOT 12 Virus marker HAVAB-M for Architect i1000 ‘or equivalent’
1)Short description
LOT 12 Virus marker HAVAB-M for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 13 Lot title: LOT 13 Cardiac marker highly sensitive troponin I, for Architect i1000, ‘or equivalent’
1)Short description
LOT 13 Cardiac marker highly sensitive troponin I, for Architect i1000, ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 14 Lot title: LOT 14 Virus marker HIV COMBO for Architect i1000 ‘or equivalent’
1)Short description
LOT 14 Virus marker HIV COMBO for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 15 Lot title: LOT 15 Determining concentration of tacrolimus for transplant patients for Architect i1000 ‘or equivalent’
1)Short description
LOT 15 Determining concentration of tacrolimus for transplant patients for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 16 Lot title: LOT 16 Tumor marker SCC for Architect i1000 ‘or equivalent’
1)Short description
LOT 16 Tumor marker SCC for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 17 Lot title: LOT 17 Virus marker ANTI HBC M for Architect i1000 ‘or equivalent’
1)Short description
LOT 17 Virus marker ANTI HBC M for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 18 Lot title: LOT 18 Concentrated washing buffer for Architect i1000 “or equivalent,, maximum 4L
1)Short description
LOT 18 Concentrated washing buffer for Architect i1000 “or equivalent,, maximum 4L.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 19 Lot title: LOT 19 Agent for conditioning the needle for sampling for Architect i1000 ‘or equivalent’
1)Short description
LOT 19 Agent for conditioning the needle for sampling for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 20 Lot title: LOT 20 Activation solution (polyethylene glycol octiphenyl ether and sodium hydroxide) for Architect i1000 ,,or equivalent" maximum 4L
1)Short description
LOT 20 Activation solution (polyethylene glycol octiphenyl ether and sodium hydroxide) for Architect i1000 ,,or equivalent" maximum 4L.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 21 Lot title: LOT 21 Re-activation solution (1.32 % hydrogen peroxide) for Architect i1000 ,,or equivalent" maximum 4L
1)Short description
LOT 21 Re-activation solution (1.32 % hydrogen peroxide) for Architect i1000 ,,or equivalent" maximum 4L.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 22 Lot title: LOT 22 Plastic cups for samples min. height 48,87mm, opening with min. 7,55 mm diameter and conical bottom with min. diameter of 5.39 for Architect i1000 ‘or equivalent’
1)Short description
LOT 22 Plastic cups for samples min. height 48,87mm, opening with min. 7,55 mm diameter and conical bottom with min. diameter of 5.39 for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 23 Lot title: LOT 23 Reactive cells plastic with hole long min.14,4 wide min.7,04mm mm and high min.4,0mm, with height and width of the reaction cell min.39,8 mm and 10,5mm with conical bottom for Architect i1000 ‘or equivalent’
1)Short description
LOT 23 Reactive cells plastic with hole long min.14,4 wide min.7,04mm mm and high min.4,0mm, with height and width of the reaction cell min.39,8 mm and 10,5mm with conical bottom for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 24 Lot title: LOT 24 Rubber caps for reagent for Architect i1000, ‘or equivalent’
1)Short description
LOT 24 Rubber caps for reagent for Architect i1000, ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 25 Lot title: LOT 25 Replacement plastic caps for reagent with an inner and an outer diameter of min. 30mm and 35,28mm for Architect i1000 ‘or equivalent’
1)Short description
LOT 25 Replacement plastic caps for reagent with an inner and an outer diameter of min. 30mm and 35,28mm for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 26 Lot title: LOT 26 Tumor marker HE4 for Architect i1000 ‘or equivalent’
1)Short description
LOT 26 Tumor marker HE4 for Architect i1000 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 27 Lot title: LOT 27 Test kit for the determination of vanilla mandelic acid in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 ‘or equivalent’, with a minimum of 20 tests in pack
1)Short description
LOT 27 Test kit for the determination of vanilla mandelic acid in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 ‘or equivalent’, with a minimum of 20 tests in pack.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 28 Lot title: LOT 28 Test kit for the determination of metanefrin in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 ‘or equivalent’, with a minimum of 40 tests in pack
1)Short description
LOT 28 Test kit for the determination of metanefrin in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 ‘or equivalent’, with a minimum of 40 tests in pack.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 29 Lot title: LOT 29 Test kit for the determination of 17 ketogenic steroids in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 ‘or equivalent’
1)Short description
LOT 29 Test kit for the determination of 17 ketogenic steroids in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 30 Lot title: LOT 30 Test kit for the determination of 17 hydroxycorticosteroids in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 ‘or equivalent’
1)Short description
LOT 30 Test kit for the determination of 17 hydroxycorticosteroids in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
4)Indication about different date for duration of contract or starting/completion
5)Additional information about lots
Lot No: 31 Lot title: LOT 31 Test kit for the determination of 5 hydroxy indolcent acid in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 ‘or equivalent’
1)Short description
LOT 31 Test kit for the determination of 5 hydroxy indolcent acid in urine chromatographic — spectrophotometric method for apparatus Hitachi U 1100 ‘or equivalent’.
2)Common procurement vocabulary (CPV)

33000000

3)Quantity or scope
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
The performance of the contract is subject to particular conditions: no
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: A Document for registered activity– DRD Form or a Confirmation for registered activity:
— Solution for wholesale of drugs under 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 impoused,and
— a certificate that a misdemeanor sanction resulting in prohibition for practicing profession, performing activity or EN Standard form 02 — Contract notice 7 / 16 duty, i.e. temporary prohibition for performing a particular activity, 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 devices:
— The economic operator for the offered goods shall have secured Approval for placing the medical device on the market or Temporary or permanent authorization for parallel imports, according to the Law on Medicines and Medical Devices.
For non-registered medical devices:
— The economic operator for the offered goods shall have a document allowing imports (approval for intervention import) under the Law on Medicines and Medical Devices.
Minimum level(s) of standards possibly required:
For registered medical devices:
— Decision for placing the medical device on the market or Temporary or permanent authorization for parallel imports, according to the Law on Medicines and Medical Devices.
For non-registered medical devices:
— Import License (approval 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
IV.2.2)Information about electronic auction
IV.3)Administrative information
IV.3.1)File reference number attributed by the contracting authority:
IV.3.2)Previous publication(s) concerning the same contract
IV.3.3)Conditions for obtaining specifications and additional documents or descriptive document
IV.3.4)Time limit for receipt of tenders or requests to participate
20.2.2017 - 15:00
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: Macedonia.
IV.3.7)Minimum time frame during which the tenderer must maintain the tender
IV.3.8)Conditions for opening of tenders
Date: 20.2.2017 - 15:00

Place:

Public Health Institute University Clinic for Clinical Biochemistry — Skopje

Persons authorised to be present at the opening of tenders: yes
Additional 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 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 commision on public procurement
bul. 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:
23.1.2017

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