(MK) Nabavka inhibitora TKI druge generacije za liječenje pacijenata u okviru JZU Univerzitetska klinika za hematologiju Skoplje

Datum objave: 24.02.2021. 09:34 / Izvor: Official Journal of the European Union, 24.02.2021.

Sjeverna Makedonija-Skopje: Medicinske naprave, lijekovi i proizvodi za osobnu njegu

2021/S 038-096323

Obavijest o nadmetanju

Roba

Pravna osnova:

Direktiva 2014/24/EU

Odjeljak I: Javni naručitelj

I.1)Naziv i adrese

Službeni naziv: Agency for medicines and medical devices
Mjesto: Skopje
NUTS kod: MK00 Северна Македонија (North Macedonia)
Poštanski broj: 1000
Država: Sjeverna Makedonija
Osoba za kontakt: Shpend Saliu
E-pošta: shpend.saliu@malmed.gov.mk
Telefon: +389 25112394
Internetska(-e) adresa(-e):
Glavna adresa: https://malmed.gov.mk/

I.3)Komunikacija

Pristup dokumentaciji o nabavi je ograničen. Više informacija dostupno je na: https://www.e-nabavki.gov.mk/PublicAccess/Home.aspx#/home

Dodatne informacije dostupne su na prethodno navedenoj adresi

Ponude ili zahtjevi za sudjelovanje moraju se podnijeti elektronički na: https://www.e-nabavki.gov.mk/PublicAccess/Home.aspx#/home

I.4)Vrsta javnog naručitelja

Ministarstvo ili drugo državno ili federalno tijelo, uključujući njihove regionalne ili lokalne jedinice

I.5)Glavna djelatnost

Zdravstvo

Odjeljak II: Predmet

II.1)Opseg nabave

II.1.1)Naziv:

Procurement of Second-generation TKI Inhibitors for Treatment of Patients within PHI University Clinic of Hematology — Skopje

II.1.2)Glavna CPV oznaka

33000000 Medicinske naprave, lijekovi i proizvodi za osobnu njegu

II.1.3)Vrsta ugovora

Roba

II.1.4)Kratak opis:

Procurement of second-generation TKI inhibitors for treatment of patients with chronic myeloid leukemia within PHI University Clinic of Hematology — Skopje.

II.1.5)Procijenjena ukupna vrijednost

Vrijednost bez PDV-a: 18 095 239.00 MKD

II.1.6)Podaci o grupama

Ovaj ugovor podijeljen je na grupe: da

Ponude se mogu podnijeti za sve grupe

II.2)Opis

II.2.1)Naziv:

Procurement of L01ХЕ08, Nilotinib 200 mg

Grupa br.: 1

II.2.2)Dodatne šifre CPV-a

33000000 Medicinske naprave, lijekovi i proizvodi za osobnu njegu

II.2.3)Mjesto izvršenja

NUTS kod: MK00 Северна Македонија (North Macedonia)

II.2.4)Opis nabave:

Procurement of second-generation TKI inhibitors for treatment of patients with chronic myeloid leukemia within PHI University Clinic of Hematology — Skopje.

II.2.5)Kriteriji za dodjelu

Niže navedeni kriteriji

Cijena

II.2.6)Procijenjena vrijednost

II.2.7)Trajanje ugovora, okvirnog sporazuma ili dinamičkog sustava nabave

Trajanje u mjesecima: 12

Ovaj ugovor podložan je obnavljanju: ne

II.2.10)Podaci o varijantama

Varijante su dopuštene.: ne

II.2.11)Podaci o opcijama

Opcije: ne

II.2.13)Podaci o fondovima Europske unije

Nabava je povezana s projektom i/ili programom koji se financira iz fondova Europske unije: ne

II.2.14)Dodatni podaci

II.2)Opis

II.2.1)Naziv:

Procurement of L01XE06, Dasatinib, 20 mg

Grupa br.: 2

II.2.2)Dodatne šifre CPV-a

33000000 Medicinske naprave, lijekovi i proizvodi za osobnu njegu

II.2.3)Mjesto izvršenja

NUTS kod: MK00 Северна Македонија (North Macedonia)

II.2.4)Opis nabave:

Procurement of second-generation TKI inhibitors for treatment of patients with chronic myeloid leukemia within PHI University Clinic of Hematology — Skopje.

II.2.5)Kriteriji za dodjelu

Niže navedeni kriteriji

Cijena

II.2.6)Procijenjena vrijednost

II.2.7)Trajanje ugovora, okvirnog sporazuma ili dinamičkog sustava nabave

Trajanje u mjesecima: 12

Ovaj ugovor podložan je obnavljanju: ne

II.2.10)Podaci o varijantama

Varijante su dopuštene.: ne

II.2.11)Podaci o opcijama

Opcije: ne

II.2.13)Podaci o fondovima Europske unije

Nabava je povezana s projektom i/ili programom koji se financira iz fondova Europske unije: ne

II.2.14)Dodatni podaci

II.2)Opis

II.2.1)Naziv:

L01XE06, Dasatinib, 50 mg

Grupa br.: 3

II.2.2)Dodatne šifre CPV-a

33000000 Medicinske naprave, lijekovi i proizvodi za osobnu njegu

II.2.3)Mjesto izvršenja

NUTS kod: MK00 Северна Македонија (North Macedonia)

II.2.4)Opis nabave:

Procurement of second-generation TKI inhibitors for treatment of patients with chronic myeloid leukemia within PHI University Clinic of Hematology — Skopje.

II.2.5)Kriteriji za dodjelu

Niže navedeni kriteriji

Cijena

II.2.6)Procijenjena vrijednost

II.2.7)Trajanje ugovora, okvirnog sporazuma ili dinamičkog sustava nabave

Trajanje u mjesecima: 12

Ovaj ugovor podložan je obnavljanju: ne

II.2.10)Podaci o varijantama

Varijante su dopuštene.: ne

II.2.11)Podaci o opcijama

Opcije: ne

II.2.13)Podaci o fondovima Europske unije

Nabava je povezana s projektom i/ili programom koji se financira iz fondova Europske unije: ne

II.2.14)Dodatni podaci

Odjeljak III: Pravni, gospodarski, financijski i tehnički podaci

III.1)Uvjeti sudjelovanja

III.1.1)Sposobnost obavljanja profesionalne djelatnosti, uključujući zahtjeve koji se odnose na upis u strukovne ili obrtne registre

Popis i kratki opis uvjeta:

To prove their capability for performance of professional activity, the economic operators shall submit document:

— for registered activity as evidence that they have been registered as natural or legal person for the performance of the activity related to the subject of the contract for public procurement or evidence that they belong to appropriate professional association in accordance with the regulations of the country of registration;

— confirmation issued from authorized body for compliance of special criteria for performing legal business activity related to the public procurement subject. A decision issued by the Agency for medicines and medical devices of RM, approving whole sale trading with drugs.

III.1.3)Tehnička i stručna sposobnost

Popis i kratki opis kriterija za odabir:

• declare a statement for full time employee with university degree in medicine or pharmacy in charge for pharmacovigilance and detection of problems in the drugs quality or errors in the drug’s series, submitting his/her data: name, surname, profession and contact phone in order to be available at any time;

• graduated pharmacist licensed to work in the procurement phases (reception, keeping and issuing drugs);

• declare a statement that the conditions for drugs safe keeping, accommodation, transport and managing are fulfilled pursuant to the Guidance for the conditions related to the space, equipment and human resources for awarding approval for whole sale trade with drugs (Off. Gazette of RM No 151/08);

Odjeljak IV: Postupak

IV.1)Opis

IV.1.1)Vrsta postupka

Otvoreni postupak

IV.1.3)Podaci o okvirnom sporazumu ili dinamičkom sustavu nabave

IV.1.6)Podaci o elektroničkoj dražbi

Provodit će se elektronička dražba

Dodatni podaci o elektroničkoj dražbi:

The electronic auction will be performed through ESPP (https://e-nabavki.gov.mk).Detailed information on the use of electronic means: In order to be able to participate in the procedure, you should register in the ESPP.

IV.1.8)Podaci o Sporazumu o javnoj nabavi (GPA)

Nabava je obuhvaćena Sporazumom o javnoj nabavi: ne

IV.2)Administrativni podaci

IV.2.2)Rok za dostavu ponuda ili zahtjeva za sudjelovanje

Datum: 19/03/2021

Lokalno vrijeme: 11:00

IV.2.3)Procijenjeni datum slanja poziva na dostavu ponuda ili na sudjelovanje odabranim natjecateljima

IV.2.4)Jezici na kojima se mogu dostaviti ponude ili zahtjevi za sudjelovanje:

Makedonski

IV.2.7)Uvjeti za otvaranje ponuda

Datum: 19/03/2021

Lokalno vrijeme: 11:00

Mjesto:

Agency for medicines and medical devices.

Podaci o ovlaštenim osobama i postupku otvaranja:

Only authorized representatives of tenderers may attend in the procedure of public opening of the tenders by comments in the minutes on tenders opening.

Authorized representatives of economic operators shall bring at the public opening authorizations signed by the responsible person of the economic operator.

Odjeljak VI: Dopunski podaci

VI.1)Podaci o obnavljanjima

Ova nabava će se ponavljati.: ne

VI.3)Dodatni podaci:

The contracting authority shall exclude the economic operator from the public procurement procedure if it determines that the economic operator or the person who is a member of the management or supervisory body of that economic operator or has powers to represent or make decisions or supervise it in the last 5 has been sentenced for years by a final court verdict for a criminal offense which has elements of the following criminal offenses established in the criminal code:

— participation in criminal association;

— corruption;

— tax evasion and contributions;

— terrorism or offenses related to terrorist activities;

— money laundering and financing of terrorism; and

— abuse of child labor and human trafficking.

The contracting authority shall exclude from the procedure for public procurement contract awarding every economic operator:

(a) who has unpaid taxes, contributions or other public duties, unless he has been authorized to defer payment of taxes, contributions or other public duties in accordance with special regulations and regularly pays them;

(b) is in bankruptcy or liquidation procedure;

(c) against which secondary penalty prohibition to participate in public calls, contracts for public procurement and contracts for public private partnership awarding has been passed;

(d) against which secondary penalty of temporary or permanent prohibition to perform certain activity has been passed;

(e) against whom misdemeanor sanction — prohibition to perform profession, activity or duty or temporary prohibition to perform activity has been passed;

(f) who has given false data or failed to deliver the data requested by the contracting authority.

The bidder submits Certificate issued by the Drugs Bureau to the authorized person for procurement implementation, certifying that the cold chamber and alarm system in case of temperature variations and the aggregate are functional.

Note: in order to qualify, the bidder in addition to the bid, besides the standard documents (proof of personal status, capacity for professional activity; technical and professional status), submits:

• certificate for quality of drug product issued by the manufacturer no more than 3 year olds; or

• certificate for trading with drug product issued by the manufacturer no more than 3 year olds;

• registration approval for whole sale trade with drugs or temporary or final approval for parallel import, pursuant to the Lawon drugs and medical aids issued by Drugs Bureau or if the medicine has not been approved — approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan;

• declare a statement that at the moment of reception of the drugs, the expiry date shall be at least 12 months valid out of the total drugs expiry date. If the bid does not cover the requested certificates/registration approval/statement, shall be considered as unacceptable and as such rejected by the Public Procurement Commission.

The tender as well as the overall correspondence and documents related to the tender shall be submitted in Macedonian.

The bid shall be submitted electronically through the Electronic System for Public Procurement (ESPP): https://enabavki.gov.mk/PublicAccess/Home.aspx#/home

The Macedonian version of tender documentation is available for free on the ESJN website: https://enabavki.gov.mk/PublicAccess/Home.aspx#/home, after being registered as an economic operator.

The signing of the contract with the selected most favorable tenderer shall be conditioned by the provision of guarantee by the selected most favorable tenderer for high quality execution of the contract to the level of 5%of the contract value.

VI.4)Postupci pravne zaštite

VI.4.1)Tijelo nadležno za postupak pravne zaštite

Službeni naziv: State appeal commission on public procurement
Mjesto: Skopje
Država: Sjeverna Makedonija

VI.5)Datum slanja ove obavijesti:

19/02/2021

 

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