Urwashanza/europrocure-10-public-procurement huggingface dataset:
Public procurement notice: Contract Notice
Published: 2024-10-16
Region: ES511
Contract type: Supplies
Procedure: Open procedure
CPV classification: 34120000: Motor vehicles for transport of persons | 34121100: Public-service buses
Estimated value: 12600000 EUR
Submission deadline: 2024-10-30

Technical requirements: Contratación por procedimiento abierto para el suministro y adquisición de veinte (20) autobuses destinados al Servicio de transporte urbano de viajeros de L’Hospitalet, El Prat y otros municipios expediente MB03/2024, que MARFINA BUS presta como adjudicataria del procedimiento de  licitación abierto y público efectuado a su favor por el Área Metropolitana de Barcelona (AMB)
Solvencia económica o financiera y solvencia técnica o profesional
Contratación por procedimiento abierto para el suministro y adquisición de veinte (20) autobuses destinados al Servicio de transporte urbano de viajeros de L’Hospitalet, El Prat y otros municipios expediente MB03/2024, que MARFINA BUS presta como adjudicataria del procedimiento de  licitación abierto y público efectuado a su favor por el Área Metropolitana de Barcelona (AMB),
Public procurement notice: Contract Notice
Published: 2024-10-16
Buyer: Ministerie van Defensie
Country: NL
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33140000: Medical consumables
Estimated value: 579024 EUR
Submission deadline: 2024-12-05

Technical requirements: De opdracht betreft het sluiten van één raamovereenkomst met één ondernemer voor de levering van levering van handschoenen in diverse maten voor het ministerie van Defensie.
Public procurement notice: Contract Award Notice
Published: 2024-10-16
Region: PL518
Contract type: Services
Procedure: Other single
CPV classification: 85100000: Health services
Estimated value: 1248000 PLN
Award criteria: price

Technical requirements: udzielanie świadczeń zdrowotnych w charakterze lekarza specjalisty      w dziedzinie chorób wewnętrznych    wobec pacjentów Wielospecjalistycznego Szpitala w Miliczu , ZGODNIE Z OPISEM  ZNAJDUJĄCYM SIĘ  W WARUNKACH KONKURSU
odwołania rozpatruje Prezes MIlickiego Centrum Medycznego Sp.z o.o W RESTRUKTURYZACJI
udzielanie świadczeń zdrowotnych w charakterze lekarza specjalisty    w dziedzinie chorób wewnętrznych   wobec pacjentów Wielospecjalistycznego Szpitala w Miliczu


Award value: 1248000
Number of bids: 1
Public procurement notice: Contract Notice
Published: 2024-10-16
Region: ITI43
Contract type: Services
Procedure: Open procedure
CPV classification: 85140000: Miscellaneous health services
Estimated value: 1000001 EUR
Submission deadline: 2024-11-21
Award criteria: quality

Technical requirements: Accordi con altri operatori economici intesi a falsare la concorrenza
Violazione di obblighi in materia di diritto ambientale
Riciclaggio di proventi di attività criminose o finanziamento del terrorismo
Lavoro minorile e altre forme di tratta di esseri umani
Violazione degli obblighi in materia di diritto del lavoro

Eligibility requirements: other
Public procurement notice: Contract Award Notice
Published: 2024-10-16
Buyer: НАЦИОНАЛНА МНОГОПРОФИЛНА ТРАНСПОРТНА БОЛНИЦА "ЦАР БОРИС III"
Country: BG
Region: BG411
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33100000 | 33111000: X-ray equipment
Estimated value: 263545 BGN
Submission deadline: 2025-12-14
Award criteria: price

Technical requirements: „Доставка, монтаж , въвеждане в експлоатация, обучение и гаранционен сервиз на медицинска апаратура  по обособени позиции за нуждите на Национална Многопрофилна Транспортна Болница „Цар Борис ІІІ”както следва:
Обособена позиция № 1- Стационарна сонографска система висок клас
Обособена позиция № 2- Система за образен анализ на костна плътност за цяло тяло
Изпълнението на договора по  ОП2 се възлага при условията на чл. 114 от ЗОП, поради липса на осигурено финансиране при откриване на процедурата. Във връзка с последното, настоящия договор се счита за сключен под условие, като изпълнението им ще започне след потвърждение за осигуряване на финансиране, за което Възложителят уведомява писмено Изпълнителя. На основание чл. 114 от ЗОП всяка от страните може да поиска прекратяване на договора след изтичане на 3-месечен срок от неговото сключване.
Когато след изтичанена 10-месечен срок от сключване на договора не е осигурено финансиране, договорът се счита за прекратен.
Настоящата обществена поръчка се възлага въз основа на икономически най-изгодна оферта. Икономически най-изгодната оферта се определя въз основа на следния критерий за възлагане – „най – ниска цена”. 
На първо място се класира офертата с предложена най–ниска обща цена без вкл. ДДС.
Доставка, монтаж , въвеждане в експлоатация, обучение и гаранционен сервиз на  Система за образен анализ на костна плътност за цяло тяло- 1 брой- Обособена позиция 2


Winner: ИНФИНИТА ООД
Award value: 95095
Number of bids: 3
Public procurement notice: Contract Award Notice
Published: 2024-10-16
Buyer: Bundesrepublik Deutschland, vertreten durch das Bundesministerium des Innern und für Heimat, vertreten durch das Beschaffungsamt des BMI
Country: DE
Region: DEA22
Contract type: Services
Procedure: Open procedure
CPV classification: 72222000: Information systems strategic planning services | 72223000: Information technology requirements review services | 72225000: Systems quality assurance services | 79417000
Award criteria: quality, price

Technical requirements: Ein Antrag auf Nachprüfung kann schriftlich an die Vergabekammern des Bundes beim Bundeskartellamt, Kaiser-Friedrich-Straße 16, 53113 Bonn, gerichtet werden. Die Unwirksamkeit des Vertrages gemäß § 135 GWB kann innerhalb von 30 Kalendertagen nach Veröffentlichung dieser Bekanntmachung im Amtsblatt der Europäischen Union geltend gemacht werden.
Rahmenvereinbarung  über Prüfungen gemäß § 8a Abs. 4 BSIG (Tiefenprüfungen) durch Dritte im Auftrag des BSI

Der über die Rahmenvereinbarung abrufbare Höchstmenge beträgt 60 Tiefenprüfungen bzw. 2220 Personentagen über die gesamte Laufzeit der Rahmenvereinbarung (Fixe Laufzeit 2 Jahre + zweimalige Option auf Verlängerung um jeweils 12 Monate).


Winner: HiSolutions AG
Number of bids: 5
Public procurement notice: Contract Award Notice
Published: 2024-10-16
Region: ES230
Contract type: Services
Procedure: Negotiated with prior call for competition
CPV classification: 85121000: Medical services
Estimated value: 209850 EUR
Award criteria: price, quality

Technical requirements: SERVICIO DE REALIZACIÓN DE ECOGRAFÍAS EN EL CENTRO DE ALTA RESOLUCIÓN
DE PROCESOS ASISTENCIALES (CARPA) DEL SERVICIO RIOJANO DE SALUD.


Award value: 209850
Number of bids: 1
Public procurement notice: Contract Award Notice
Published: 2024-10-16
Buyer: Monaghan County Council
Country: IE
Contract type: Works
Procedure: Open procedure
CPV classification: 45230000 | 45233110 | 45233121: Main road construction work
Award criteria: price

Technical requirements: This section of the network was identified as in need of repair, cracking and rutting are visible along the length of the scheme. Previously patching had been carried out on the pavement at various locations along the route. The works will be undertaken along the N12 in Knockaconny to Tullylish, Co. Monaghan. The scope of the works involves everything that is contained within the Works Requirements. As a guide, the project comprises, but is not limited to: • Site Clearance; • Removing existing road studs• Renewal of existing filter drain material; • Raising / lowering of chamber covers / gully gratings where necessary; Applying bond coat; • Laying bituminous pavement materials in accordance with Appendix 7/1 of the Works Requirements and Series 900 of the TII Specification for Road Works (SRW); • Replacement of damaged kerbs; • Applying road markings in accordance with Appendix 12/3 of the Works Requirements and Series 1200 of the TII SRW; •


Winner: Monaghan County Council
Public procurement notice: Contract Notice
Published: 2024-10-16
Region: LV006
Contract type: Services
Procedure: Open procedure
CPV classification: 72000000 | 72260000: Software-related services
Estimated value: 2100000 EUR
Submission deadline: 2024-11-07
Award criteria: price, quality

Technical requirements: Saskaņā ar iepirkuma tehnisko specifikāciju un iepirkuma līguma projektu
Pretendenta piedāvātajam risinājumam ir jānosedz 100% no tehniskajā specifikācijā norādītajām sistēmas obligātajām prasībām
Pretendentam jāveic detalizēta risinājuma demonstrācija
Vienreizējas licenču maksas samaksa ir sadalīta vairākos maksājumos
Vismaz 90% no pretendenta komandas dalībniekiem jāsāk un jābeidz savs darba laiks divu stundu robežās no Latvijas laika zonas (GMT+2).
Public procurement notice: Contract Notice
Published: 2024-10-16
Buyer: Oslo kommune v/ Renovasjons- og gjenvinningsetaten
Country: NO
Region: NO020
Contract type: Supplies
Procedure: Open procedure
CPV classification: 34328300 | 34928110 | 34928300 | 34990000 | 35100000: Emergency and security equipment
Estimated value: 4600000 NOK
Submission deadline: 2024-11-19
Award criteria: price

Technical requirements: Is the supplier in a situation where he has been forced debt arrangement?  Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions.
Is the tenderer in a bankruptcy situation? Specify why, under the mentioned circumstances, one is able to carry out the contract, considering the current national provisions and measures for continuing the business activities? It is not necessary to provide this information if rejection of tenderers made mandatory in accordance with the current national law without the possibility for exceptions.
Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies, in the event a enforceable verdict has been convicted of corruption by a verdict handed down not more than five years ago, or a rejection period determined directly in the judgement that still applies? Corruption as defined in Article 3 of the Convention on Combating Corruption, Involving European Communities or European Union Member States (EUT C 195 of 25.6.1997, s. 1), and in Article 2, point 1, in the Council ́s framework decision 2003/568/RIA of 22 July 2003 on combating corruption in the private sector (EUT L 192 of 31.7.2003,  p. 54). This rejection reason also includes corruption as defined in national law for the contracting authority or supplier.
Is the tenderer himself or a person, who is a member of the tenderer's administration, management or supervisory body or has the competence to represent or control or make decisions in such bodies, at the time a legally convicted verdict of participation in a criminal organisation by a verdict handed down no more than five years ago, or a rejection period set out directly in the judgement that still applies? Participation in a criminal organisation as defined in Article 2 of the Council ́s framework decision 2008/841/RIA of 24 October 2008 on control of organised crime (EUT L 300 of 11.11.2008, p. 42)
Has the tenderer entered into agreement(s) with other tenderers with the intention of turning the competition?
Public procurement notice: Contract Notice
Published: 2024-10-16
Buyer: Klinički bolnički centar Zagreb
Country: HR
Region: HR050
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33600000: Pharmaceutical products
Estimated value: 12925260.61 EUR
Submission deadline: 2024-11-19
Award criteria: price, quality

Technical requirements: Kaznena djela terorizma ili kaznena djela povezana s terorističkim aktivnostima
Plaćanje obveza za mirovinsko i zdravstveno osiguranje
Sukob interesa koji proizlazi iz sudjelovanja u postupku nabave
Narušavanje tržišnog natjecanja zbog izravnog ili neizravnog sudjelovanja u pripremi ovog postupka nabave
Ostali lijekovi (koji nisu uključeni u kategorije pod rednim brojem 1. i 17.) - IX za zdravstvene ustanove u Republici Hrvatskoj.

Predmet nabave su lijekovi koji se nalaze na Osnovnoj i Dopunskoj listi lijekova Hrvatskog zavoda za zdravstveno osiguranje (dalje u tekstu HZZO), a koji ne spadaju u kategoriju pod brojem 1. Lijekovi na listama HZZO-a koji imaju generičke paralele ni u kategoriju pod rednim brojem 17. Posebne skupine lijekova.

Predmet nabave su lijekovi koji se nalaze na Osnovnoj i Dopunskoj listi lijekova Hrvatskog zavoda za zdravstveno osiguranje samo pod nezaštićenim nazivom, a koji ne spadaju u kategoriju pod brojem 1. Lijekovi na listama HZZO-a koji imaju generičke paralele ni u kategoriju pod rednim brojem 17. Posebne skupine lijekova.

Za  lijekove koji se nalaze na Osnovnoj i Dopunskoj listi lijekova Hrvatskog zavoda za zdravstveno osiguranje samo pod nezaštićenim nazivom, potrebno je ishoditi suglasnost Povjerenstva za lijekove, a za pojedine grupe lijekova i Suglasnost za interventni uvoz lijeka, sukladno članku 64. članak 120. i članak 129. Zakona o lijekovima (NN 76/13, 90/14, 100/18).
Interventni unos i uvoz lijekova podrazumijeva unos i uvoz lijekova koji nemaju odobrenje za stavljanje u promet u Republici Hrvatskoj. 

Agencija za lijekove i medicinske proizvode (dalje u tekstu: HALMED) može izvanredno dati suglasnost za unošenje ili uvoz lijeka za koji nije dano odobrenje za stavljanje u promet u Republici Hrvatskoj, a koji će se primjenjivati za liječenje bolesnika, u sljedećim slučajevima: - za nužne slučajeve pojedinačnog liječenja lijekom koji je na vlastitu odgovornost propisao doktor medicine ili doktor dentalne medicine koji provodi liječenje- u slučaju medicinski opravdane potrebe, radi zaštite zdravlja ljudi - za slučaj elementarnih nepogoda ili drugih izvanrednih stanja - za klinička ispitivanja.

Ukoliko na tržištu u trenutku podnošenja ponuda postoji registrirani lijek koji ima rješenje HALMED-a i koji je u prometu u RH  ponuditelj može ponuditi samo taj lijek


Winner: KLINIČKI BOLNIČKI CENTAR SPLIT
Public procurement notice: Contract Notice
Published: 2024-10-16
Buyer: Uždaroji akcinė bendrovė 'VILNIAUS VANDENYS'
Country: LT
Region: NO081
Contract type: Supplies
Procedure: Open procedure
CPV classification: 48611000: Database software package
Submission deadline: 2024-10-24

Technical requirements: Microsoft programinės įrangos (SQL) licencijų prenumerata


Winner: Mercell Holding ASA
Public procurement notice: Contract Award Notice
Published: 2024-10-16
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33600000: Pharmaceutical products | 33611000 | 33612000 | 33613000 | 33615100
Estimated value:  RON
Award criteria: price

Technical requirements: Furnizarea de medicamente, conform caietului de sarcini, prin incheierea unui Acord-cadru cu operatorii economici ale caror oferte admisibile se vor pozitiona pe primele 3 locuri in clasamentul intocmit in baza criteriului de atribuire mentionat la punctul II.2.5.din Fisa de date a achizitiei. Contractele subsecvente se vor încheia de către fiecare utilizator în parte cu operatorul economic declarat câștigător pentru cantitățile solicitate de către utilizatorul respectiv.
Numar zile pana la care se pot solicita clarificari inainte de data limita de depunere a ofertelor/candidaturilor: 18 zile 
Autoritatea Contractanta va raspunde in mod clar tuturor solicitarilor de clarificari/informatiilor suplimentare in a 11-a zi inainte de data limita de depunere a ofertelor conform termenului fix stabilit in OUG 107/2017.
Descrierea produsului, cantitățile minime și maxime, atât pe acord cadru, cât și pe contract subsecvent, precum și valorile estimate se regăsesc în caietul de sarcini.


Conform caietului de sarcini
Cantitățile minime și maxime atât pe acord cadru, cât și pe contract subsecvent, precum și valorile estimate se regăsesc în caietul de sarcini - capitolul 9.


Award value: 24555875.45
Number of bids: 4
Public procurement notice: Contract Notice
Published: 2024-10-16
Buyer: Gemeente Zutphen
Country: NL
Region: NL225
Contract type: Works
Procedure: Restricted procedure
CPV classification: 45211000: Construction work for multi-dwelling buildings
Submission deadline: 2024-11-14
Award criteria: quality, price

Technical requirements: Het realiseren van een appartementengebouw met koopappartementen op Kavel18 van de gebiedsontwikkeling Noorderhaven Zutphen. Beoogde doelgroepen: jongeren en starters. Onderhavige opdracht wordt via koop- en realisatieovereenkomst op de markt gezet. Het ontwikkelen van 42 koopappartementen in het middensegment.
Public procurement notice: Contract Notice
Published: 2024-10-16
Region: EL307
Contract type: Supplies
Procedure: Open procedure
CPV classification: 30200000 | 30213300 | 32424000 | 72253200: Computer systems support services | 72500000
Estimated value: 550000 EUR
Submission deadline: 2024-11-05
Award criteria: price

Technical requirements: ΣΥΝΤΗΡΗΣΗ ΕΘΝΙΚΟΥ ΔΙΚΤΥΟΥ ΤΗΛΕΪΑΤΡΙΚΗΣ (ΕΔΙΤ) ΤΗΣ 2ης ΥΠΕ ΠΕΙΡΑΙΩΣ ΚΑΙ ΑΙΓΑΙΟΥ
ΥΠΟΕΡΓΟ Α: ΠΡΟΜΗΘΕΙΑ ΕΞΟΠΛΙΣΜΟΥ ΓΙΑ ΤΗΝ ΚΕΝΤΡΙΚΗ ΥΠΟΔΟΜΗ ΤΟΥ ΕΔΙΤ, ΚΑΘΩΣ ΚΑΙ ΑΝΑΝΕΩΣΗ ΤΟΥ ΑΠΑΡΑΙΤΗΤΟΥ ΛΟΓΙΣΜΙΚΟΥ ΚΑΙ ΤΩΝ ΣΥΝΑΦΩΝ ΥΠΗΡΕΣΙΩΝ
ΥΠΟΕΡΓΟ Β: ΠΡΟΜΗΘΕΙΑ Η/Υ ΚΑΙ UPS ΓΙΑ ΤΑ 43 ΣΗΜΕΙΑ (ΣΤΙΣ / ΣΤΙΑ) ΤΟΥ ΕΔΙΤ - 1
ΥΠΟΕΡΓΟ Γ: ΕΓΚΑΤΑΣΤΑΣΗ, ΠΑΡΑΜΕΤΡΟΠΟΙΗΣΗ ΚΑΙ ΕΝΣΩΜΑΤΩΣΗ ΣΤΟ ΣΥΣΤΗΜΑ ΤΗΛΕΪΑΤΡΙΚΗΣ ΤΟΥ ΥΠΟ ΠΡΟΜΗΘΕΙΑ ΕΞΟΠΛΙΣΜΟΥ ΚΑΙ ΛΟΓΙΣΜΙΚΟΥ
Public procurement notice: Contract Award Notice
Published: 2024-10-16
Buyer: Fraport AG
Country: DE
Region: DE712
Contract type: Supplies
Procedure: Negotiated with prior call for competition
CPV classification: 35000000: Security, fire-fighting, police and defence equipment | 35120000: Surveillance and security systems | 75240000
Submission deadline: 2031-12-31
Award criteria: quality, price

Technical requirements: Lieferung und Instandhaltung von Luftsicherheitsausrüstung gemäß Anlage R3 des Nationalen Luftsicherheitsprogramm (NLSP) für die Fraport AG

Hier: Sicherheitsscanner (SSC) sowie Peripherie und Datenmanagementsystem
Lieferung und Instandhaltung von Luftsicherheitsausrüstung gemäß Anlage R3 des Nationalen Luftsicherheitsprogramm (NLSP) für die Fraport AG - Hier: Sicherheitsscanner (SSC) sowie Peripherie und Datenmanagementsystem.

Die im Preisblatt (Anhang 1) aufgeführten Mengen werden für den Angebotsvergleich (mögliche Gesamtlaufzeit: bis max. 31.12.2031) zugrunde gelegt.

Es wird ausdrücklich darauf hingewiesen, dass die angegebenen Mengen lediglich als Orientierungswert dienen, nicht verbindlich sind, daraus keinerlei Abnahmeverpflichtung ableitbar ist und die Mengen jederzeit dem jeweiligen Bedarf oder den betrieblichen Erfordernissen angepasst werden können.

Alle wesentlichen Informationen können den informatorischen Vergabeunterlagen entnommen werden.
2 Mal 1 Jahr optionale Verlängerung (voraussichtlich 01.01.2030 - 31.12.2030 und voraussichtlich 01.01.2031 - 31.12.2031)


Winner: Rohde & Schwarz GmbH & Co. KG
Number of bids: 2
Public procurement notice: Contract Notice
Published: 2024-10-16
Buyer: Verbandsgemeinde Altenahr
Country: DE
Region: DEB12
Contract type: Supplies
Procedure: Open procedure
CPV classification: 34144210: Road-sweeping vehicles | 35000000: Security, fire-fighting, police and defence equipment
Submission deadline: 2024-11-13

Technical requirements: Lieferung von drei TSF-W für die Feuerwehr der VG Altenahr aufgeteilt in
Los 1 TSF-W
Teil A - Fahrgestell, Teil B - Aufbau
Die Beauftragung erfolgt wie folgt:
1 TSF-W in 2024 und 2 TSF-W in 2025
Ein Nachprüfungsantrag ist nach § 160 Abs.3 GWB unzulässig, wenn 1. der Antragsteller den geltend gemachten Verstoß gegen Vergabevorschriften vor Einreichen des Nachprüfungsantrags erkannt und gegenüber dem Auftraggeber nicht innerhalb einer Frist von zehn
Kalendertagen gerügt hat 2. Verstöße gegen Vergabevorschriften, die aufgrund der Bekanntmachung erkennbar sind, nicht spätestens bis zum Ablauf der in der Bekanntmachung benannten Frist zur Bewerbung oder zur Angebotsabgabe gegenüber dem Auftraggeber gerügt werden, 3. Verstöße gegen Vergabevorschriften, die erst in den Vergabeunterlagen erkennbar sind, nicht spätestens bis zum Ablauf der Frist zur Bewerbung oder zur Angebotsabgabe gegenüber dem Auftraggeber gerügt werden, 4. mehr als 15 Kalendertage nach Eingang der Mitteilung des Auftraggebers, einer Rüge nicht abhelfen zu wollen, vergangen sind. Dies gilt nicht bei einem Antrag auf Feststellung der Unwirksamkeit des Vertrags nach § 135 Absatz 1 Nummer 2 GWB.

Eligibility requirements: other

Winner: Datenservice Öffentlicher Einkauf (in Verantwortung des Beschaffungsamts des BMI)
Public procurement notice: Contract Notice
Published: 2024-10-16
Buyer: Klinički bolnički centar Zagreb
Country: HR
Region: HR050
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33600000: Pharmaceutical products
Estimated value: 5581073.93 EUR
Submission deadline: 2024-11-22
Award criteria: price, quality

Technical requirements: Kaznena djela terorizma ili kaznena djela povezana s terorističkim aktivnostima
Plaćanje obveza za mirovinsko i zdravstveno osiguranje
Sukob interesa koji proizlazi iz sudjelovanja u postupku nabave
Narušavanje tržišnog natjecanja zbog izravnog ili neizravnog sudjelovanja u pripremi ovog postupka nabave
Ostali lijekovi (koji nisu uključeni u kategorije pod rednim brojem 1. i 17.) - X za zdravstvene ustanove u Republici Hrvatskoj.

Predmet nabave su lijekovi koji se nalaze na Osnovnoj i Dopunskoj listi lijekova Hrvatskog zavoda za zdravstveno osiguranje (dalje u tekstu HZZO), a koji ne spadaju u kategoriju pod brojem 1. Lijekovi na listama HZZO-a koji imaju generičke paralele ni u kategoriju pod rednim brojem 17. Posebne skupine lijekova.

Predmet nabave su lijekovi koji se nalaze na Osnovnoj i Dopunskoj listi lijekova Hrvatskog zavoda za zdravstveno osiguranje samo pod nezaštićenim nazivom, a koji ne spadaju u kategoriju pod brojem 1. Lijekovi na listama HZZO-a koji imaju generičke paralele ni u kategoriju pod rednim brojem 17. Posebne skupine lijekova.

Za lijekove koji se nalaze na Osnovnoj i Dopunskoj listi lijekova Hrvatskog zavoda za zdravstveno osiguranje samo pod nezaštićenim nazivom, potrebno je ishoditi suglasnost Povjerenstva za lijekove, a za pojedine grupe lijekova i Suglasnost za interventni uvoz lijeka, sukladno članku 64. članak 120. i članak 129. Zakona o lijekovima (NN 76/13, 90/14, 100/18).
Interventni unos i uvoz lijekova podrazumijeva unos i uvoz lijekova koji nemaju odobrenje za stavljanje u promet u Republici Hrvatskoj.

Agencija za lijekove i medicinske proizvode (dalje u tekstu: HALMED) može izvanredno dati suglasnost za unošenje ili uvoz lijeka za koji nije dano odobrenje za stavljanje u promet u Republici Hrvatskoj, a koji će se primjenjivati za liječenje bolesnika, u sljedećim slučajevima: - za nužne slučajeve pojedinačnog liječenja lijekom koji je na vlastitu odgovornost propisao doktor medicine ili doktor dentalne medicine koji provodi liječenje- u slučaju medicinski opravdane potrebe, radi zaštite zdravlja ljudi - za slučaj elementarnih nepogoda ili drugih izvanrednih stanja - za klinička ispitivanja.

Ukoliko na tržištu u trenutku podnošenja ponuda postoji registrirani lijek koji ima rješenje HALMED-a i koji je u prometu u RH ponuditelj može ponuditi samo taj lijek


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