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      <cbc:Name languageID="POL">Dostawa produktów leczniczych z grupy:  Leki dostępne w ramach programu lekowego; Leki, stosowane w ramach chemioterapii
w całym zakresie zarejestrowanych wskazań i przeznaczeń oraz we wskazaniu określonym stanem klinicznym; leki przeciwnowotworowe i immunomodulujące oraz immunoglobuliny niespecyficzne (zgodnie z klasyfikacją ATC) – z listy 31 pakietów
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      <cbc:Description languageID="POL">Dostawa produktów leczniczych z grupy:  Leki dostępne w ramach programu lekowego; Leki, stosowane w ramach chemioterapii
w całym zakresie zarejestrowanych wskazań i przeznaczeń oraz we wskazaniu określonym stanem klinicznym; leki przeciwnowotworowe i immunomodulujące oraz immunoglobuliny niespecyficzne (zgodnie z klasyfikacją ATC) – z listy 31 pakietów</cbc:Description>
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      <cbc:Note languageID="POL">C. PODMIOTOWYCH ŚRODKÓ DOWODOWYCH
Oświadczenia wykonawcy, w zakresie art. 108 ust. 1 pkt 5 ustawy, o braku przynależności do tej samej grupy kapitałowej w rozumieniu ustawy z dnia 16 lutego 2007 r. o ochronie konkurencji i konsumentów (Dz. U. z 2024 r. poz. 594 z innym wykonawcą, który złożył odrębną ofertę w postępowaniu, albo oświadczenia o przynależności do tej samej grupy kapitałowej wraz z dokumentami lub informacjami potwierdzającymi przygotowanie oferty niezależnie od innego wykonawcy należącego do tej samej grupy kapitałowej. Wzór oświadczenia stanowi załącznik nr 8 do SWZ
Ważna koncesja lub zezwolenie na prowadzenie hurtowni farmaceutycznej, które w świetle obowiązującego prawa w Rzeczpospolitej Polskiej uprawnia Wykonawcę do prowadzenia obrotu produktami leczniczymi, na wszystkie magazyny, z których zamierza realizować zamówienie - dotyczy produktów leczniczych.
Informacja z Centralnego Rejestru Beneficjentów Rzeczywistych, w zakresie art. 108 ust. 2 ustawy, jeżeli odrębne przepisy wymagają wpisu do tego rejestru, sporządzona nie wcześniej niż 3 miesiące przed jej złożeniem.
Weryfikacja podmiotowa na podstawie ustawy o certyfikacji wykonawców zamówień publicznych (art. 124 ustawy Pzp)
1. Zasady ogólne i uprawnienia wykonawcy (Certyfikacja):
•	Zgodnie z art. 124 ust. 2 ustawy Pzp, Wykonawca może, zamiast odpowiednich podmiotowych środków dowodowych wymaganych przez Zamawiającego w niniejszym postępowaniu, posłużyć się certyfikatem Wykonawcy zamówień publicznych, wydanym na podstawie przepisów ustawy z dnia 5 sierpnia 2025 r. o certyfikacji wykonawców zamówień publicznych (Dz. U. z 2025 r. poz. 1235, z późn. zm.), jeżeli certyfikat ten potwierdza okoliczności wymagane przez Zamawiającego w zakresie braku podstaw wykluczenia lub spełniania warunków udziału w postępowaniu.
•	Złożenie albo wskazanie certyfikatu jest uprawnieniem Wykonawcy. Zamawiający nie wymaga posiadania certyfikatu jako warunku udziału w postępowaniu i nie uzależnia możliwości ubiegania się o zamówienie od posiadania certyfikacji.
Zasady posługiwania się certyfikatem (Certyfikacja):
1.	Wykonawca może, zamiast odpowiednich podmiotowych środków dowodowych wymaganych przez Zamawiającego w niniejszym postępowaniu, posłużyć się certyfikatem Wykonawcy zamówień publicznych, jeżeli certyfikat ten potwierdza okoliczności wymagane przez Zamawiającego w zakresie braku podstaw wykluczenia lub spełniania warunków udziału w postępowaniu.
2.	Złożenie albo wskazanie certyfikatu jest uprawnieniem Wykonawcy.
3.	Zamawiający nie wymaga posiadania certyfikatu jako warunku udziału w postępowaniu i nie uzależnia możliwości ubiegania się o zamówienie od posiadania certyfikacji.
Zakres certyfikatu:
1.	Certyfikat zastępuje odpowiednie podmiotowe środki dowodowe wyłącznie w zakresie, w jakim z jego treści albo z danych ujawnionych w bazie certyfikacji wynika potwierdzenie okoliczności wymaganych przez Zamawiającego w niniejszym postępowaniu.
2.	Jeżeli certyfikat obejmuje wyłącznie część wymaganych podstaw wykluczenia albo część warunków udziału w postępowaniu, Wykonawca składa:
o	certyfikat – w zakresie objętym certyfikacją;
o	pozostałe wymagane podmiotowe środki dowodowe – w zakresie nieobjętym certyfikacją.
Dokumenty pozostające poza zakresem certyfikacji:
1.	Certyfikat nie zastępuje dokumentów, oświadczeń ani informacji, które nie stanowią podmiotowych środków dowodowych, w szczególności:
o	formularza ofertowego;
o	pełnomocnictwa;
o	zobowiązania podmiotu udostępniającego zasoby;
o	przedmiotowych środków dowodowych;
o	dokumentów lub oświadczeń dotyczących treści oferty.
Procedura składania i weryfikacji certyfikatu:
1.	Wykonawca, który zamierza posługiwać się certyfikatem Wykonawcy zamówień publicznych, powinien wskazać informację o certyfikacie w oświadczeniu JEDZ, w szczególności w części II sekcji A, w polu dotyczącym wpisu do urzędowego wykazu zatwierdzonych Wykonawców albo posiadania równoważnego certyfikatu.
2.	Wykonawca powinien podać dane umożliwiające identyfikację certyfikatu, ustalenie podmiotu certyfikującego, okresu ważności certyfikacji oraz zakresu, w jakim zamierza posługiwać się certyfikatem w niniejszym postępowaniu.
3.	Zamawiający wezwie Wykonawcę, którego oferta została najwyżej oceniona, do złożenia aktualnych na dzień złożenia podmiotowych środków dowodowych albo certyfikatu Wykonawcy zamówień publicznych zastępującego odpowiednie podmiotowe środki dowodowe, w terminie nie krótszym niż 10 dni od dnia wezwania.
4.	Certyfikat zostanie uznany przez Zamawiającego wyłącznie w zakresie, w jakim potwierdza brak podstaw wykluczenia lub spełnianie warunków udziału w postępowaniu określonych w niniejszej SWZ.
5.	Jeżeli certyfikat nie obejmuje wszystkich wymaganych okoliczności, Wykonawca zobowiązany jest złożyć pozostałe wymagane podmiotowe środki dowodowe.
Weryfikacja certyfikatu przez Zamawiającego:
1.	Zamawiający dokona weryfikacji certyfikatu w szczególności w zakresie:
•	zgodności danych Wykonawcy z danymi wskazanymi w certyfikacie;
•	ważności certyfikacji;
•	braku zawieszenia ważności certyfikacji;
•	zakresu certyfikacji;
•	zgodności zakresu certyfikacji z podstawami wykluczenia określonymi w SWZ;
•	zgodności zakresu certyfikacji z warunkami udziału w postępowaniu określonymi w SWZ.
2.	Zamawiający może dokonać weryfikacji certyfikatu przy wykorzystaniu bazy certyfikacji Wykonawców zamówień publicznych.
•	W przypadku Wykonawców wspólnie ubiegających się o udzielenie zamówienia – niżej wymienione dokumenty (lub odpowiadające im zakresy certyfikatów) składa każdy z Wykonawców występujących wspólnie.
•	W przypadku innego podmiotu, na którego zdolnościach lub sytuacji podmiotów udostępniających zasoby Wykonawca polega, nw. dokumenty (lub odpowiadające im zakresy certyfikatów) składa w odniesieniu do każdego z tych podmiotów (za wyjątkiem oświadczenia nr 6 do SWZ o braku przynależności do tej samej grupy kapitałowej) - PROSZĘ NIE SKŁADAĆ ICH WRAZ Z OFERTĄ.
W ramach tabeli określonej w ust. 6.2, certyfikat braku podstaw wykluczenia w pełni zastępuje następujące podmiotowe środki dowodowe:
•	L.p. 1 (Informacja z KRK) – w zakresie art. 108 ust. 1 pkt 1, 2 i 4 Pzp;
•	L.p. 2 (Zaświadczenie z US) – w zakresie art. 109 ust. 1 pkt 1 Pzp;
•	L.p. 3 (Zaświadczenie z ZUS/KRUS) – w zakresie art. 109 ust. 1 pkt 1 Pzp;
•	L.p. 4 (Odpis z KRS / CEIDG) – w zakresie art. 109 ust. 1 pkt 4 Pzp.
Certyfikat NIE zastępuje: oświadczenia o grupie kapitałowej (L.p. 8) oraz oświadczenia o aktualności informacji w zakresie podstaw wykluczenia (L.p. 6 – Załącznik nr 5 do SWZ). Dokumenty z pozycji L.p. 5 wykonawca posługujący się certyfikatem zobowiązany jest złożyć na ogólnych zasadach, natomiast oświadczenie z pozycji L.p. 6 składa wyłącznie w ograniczonym zakresie przesłanek nieobjętych jego certyfikatem (w szczególności w zakresie krajowych i unijnych sankcji gospodarczych związanych z konfliktem w Ukrainie).
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         <cbc:Description languageID="POL">1.	W kol. 10 załącznika nr 1 do SWZ Wykonawca zobowiązany jest podać wyłącznie nazwę handlową oferowanego produktu leczniczego tożsamą z nazwą produktu użytą (podaną) w obowiązującym OBWIESZCZENIU PREZESA URZĘDU REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH w sprawie ogłoszenia Urzędowego Wykazu Produktów Leczniczych Dopuszczonych do Obrotu na terytorium Rzeczypospolitej Polskiej. W przypadku surowców farmaceutycznych należy podać nazwę zgodną z Listą Surowców Farmaceutycznych dopuszczonych do obrotu na terytorium Rzeczypospolitej Polskiej na podstawie decyzji Prezesa Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych dostępną na platformie Rejestry Medyczne. W sytuacji kiedy oferowany produkt nie jest objęty ww. Obwieszczeniem (produkty dostępne w ramach procedury importu docelowego, wyroby medyczne, środki specjalnego przeznaczenia żywieniowego) wymagane jest podanie nazwy zgodnej z ulotką lub inną dokumentacją oferowanego produktu – w takim przypadku wymagane jest załączenie ulotki/innego dokumentu potwierdzającego nazwę oferowanego produktu oraz spełnienie wymagań Zamawiającego. Każdy dokument powinien być opisany, jakiego zadania i pozycji załącznika nr 1 (arkusza asortymentowo-ilościowo-cenowego) dotyczy.
2. Warunki wymagane w kolumnie 3 i 4 załącznika nr 1 do SWZ  muszą być jednoznacznie potwierdzone w charakterystyce produktu (na żądanie wymagane jest dostarczenie strony z nazwą produktu i stron zawierających wymagane informacje) lub innym, dostarczonym dokumencie pochodzącym jednoznacznie od podmiotu odpowiedzialnego, wytwórcy lub podmiotu reprezentującego powyższych na terenie Polski (zgodnie z obowiązującym OBWIESZCZENIEM PREZESA URZĘDU REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH w sprawie ogłoszenia Urzędowego Wykazu Produktów Leczniczych Dopuszczonych do Obrotu na terytorium Rzeczypospolitej Polskie lub zgodnie z aktualnym ChPL). Konieczne jest, aby dokument taki posiadał datę nie starszą niż 6 miesięcy od daty otwarcia ofert  lub  jego aktualność musi być potwierdzona dodatkowo przez jeden ze wskazanych powyżej podmiotów również  z datą nie starszą niż 6 miesięcy od daty otwarcia ofert. W przypadku dostarczenia tłumaczenia dokumentu konieczne jest załączenie jego oryginalnej wersji językowej, a w przypadku dokumentu w innym języku niż polski musi zostać załączone jego tłumaczenie.
W celu potwierdzenia braku podstaw wykluczenia wykonawcy z udziału w postępowaniu:
1.	Informacja z Krajowego Rejestru Karnego w zakresie określonym w art. 108 ust. 1 pkt 1, 2 i 4 ustawy, sporządzonej nie wcześniej niż 6 miesięcy przed jego złożeniem
2.	Zaświadczenie właściwego naczelnika urzędu skarbowego potwierdzającego, że wykonawca nie zalega z opłacaniem podatków i opłat, w zakresie art. 109 ust. 1 pkt 1 ustawy, wystawionego nie wcześniej niż 3 miesiące przed jego złożeniem, a w przypadku zalegania z opłacaniem podatków lub opłat wraz z zaświadczeniem zamawiający żąda złożenia dokumentów potwierdzających, że odpowiednio przed upływem terminu składania wniosków o dopuszczenie do udziału w postępowaniu albo przed upływem terminu składania ofert wykonawca dokonał płatności należnych podatków lub opłat wraz z odsetkami lub grzywnami lub zawarł wiążące porozumienie w sprawie spłat tych należności;
3.	Zaświadczenie albo inny dokument właściwej terenowej jednostki organizacyjnej Zakładu Ubezpieczeń Społecznych lub właściwego oddziału regionalnego lub właściwej placówki terenowej Kasy Rolniczego Ubezpieczenia Społecznego potwierdzający, że wykonawca nie zalega z opłacaniem składek na ubezpieczenia społeczne i zdrowotne, w zakresie art. 109 ust. 1 pkt 1 ustawy, wystawiony nie wcześniej niż 3 miesiące przed jego złożeniem, a w przypadku zalegania z opłacaniem składek na ubezpieczenia społeczne lub zdrowotne wraz z zaświadczeniem albo innym dokumentem zamawiający żąda złożenia dokumentów potwierdzających, że odpowiednio przed upływem terminu składania ofert wykonawca dokonał płatności należnych składek na ubezpieczenia społeczne lub zdrowotne wraz odsetkami lub grzywnami lub zawarł wiążące porozumienie w sprawie spłat tych należności;
4.	Odpis lub Informacja z Krajowego Rejestru Sądowego lub z Centralnej Ewidencji i Informacji o Działalności Gospodarczej, w zakresie art. 109 ust. 1 pkt 4 ustawy, sporządzonych nie wcześniej niż 3 miesiące przed jej złożeniem, jeżeli odrębne przepisy wymagają wpisu do rejestru lub ewidencji;
Oświadczenie wykonawcy o aktualności informacji zawartych w oświadczeniu, o którym mowa w art. 125 ust. 1 ustawy, w zakresie podstaw wykluczenia z postępowania wskazanych przez zamawiającego, o których mowa w:
a)	art. 108 ust. 1 pkt 3 ustawy,
b)	art. 108 ust. 1 pkt 4 ustawy, dotyczących orzeczenia zakazu ubiegania się o zamówienie publiczne tytułem środka zapobiegawczego,
c)	art. 108 ust. 1 pkt 5 ustawy, dotyczących zawarcia z innymi wykonawcami porozumienia mającego na celu zakłócenie konkurencji,
d)	art. 108 ust. 1 pkt 6 ustawy,
e)	art. 109 ust. 1 pkt 1 ustawy, odnośnie do naruszenia obowiązków dotyczących płatności podatków i opłat lokalnych, o których mowa w ustawie z dnia 12 stycznia 1991 r. o podatkach i opłatach lokalnych 
(Dz. U. z 2023 r. poz. 70),
f)	na podstawie art. 7 ustawy z dnia 13 kwietnia 2022 r. o szczególnych rozwiązaniach w zakresie przeciwdziałania wspieraniu agresji na Ukrainę oraz służących ochronie bezpieczeństwa narodowego (Dz. U. z 2025 r. poz. 514.).
oraz
niepodleganiu ogólnounijnemu zakazowi udziału w postępowaniach o zamówienia publiczne rosyjskich wykonawców na podstawie art. w art. 5k Rozporządzenia Rady (UE) nr 833/2014 z dnia 31 lipca 2014 r. dotyczące środków ograniczających w związku z działaniami Rosji destabilizującymi sytuację na Ukrainie (Dz.U.UE.L.2025.2033)
Wzór oświadczenia stanowi załącznik nr 5 do SWZ
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                              <efac:AwardCriterionParameter>
                                 <efbc:ParameterCode listName="number-weight">poi-exa</efbc:ParameterCode>
                                 <efbc:ParameterNumeric>100</efbc:ParameterNumeric>
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                  </ext:UBLExtensions>
                  <cbc:AwardingCriterionTypeCode listName="award-criterion-type">price</cbc:AwardingCriterionTypeCode>
                  <cbc:Description languageID="POL">Oferowana cena brutto - 100 %</cbc:Description>
               </cac:SubordinateAwardingCriterion>
            </cac:AwardingCriterion>
         </cac:AwardingTerms>
         <cac:AdditionalInformationParty>
            <cac:PartyIdentification>
               <cbc:ID>ORG-0001</cbc:ID>
            </cac:PartyIdentification>
         </cac:AdditionalInformationParty>
         <cac:TenderRecipientParty>
            <cbc:EndpointID>https://dcopih.ezamawiajacy.pl/pn/DCOPIH/demand/309704/notice/public/details</cbc:EndpointID>
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            <cac:PartyIdentification>
               <cbc:ID>ORG-0001</cbc:ID>
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            <cbc:DurationMeasure unitCode="DAY">120</cbc:DurationMeasure>
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            <cac:PresentationPeriod>
               <cbc:Description languageID="POL">Wykonawcy i innemu podmiotowi, jeżeli ma lub miał interes w uzyskaniu danego zamówienia oraz poniósł lub może ponieść szkodę w wyniku naruszenia przez Zamawiającego przepisów ustawy Prawo zamówień publicznych z dnia 11 września 2019 r. (Dz. U. 2024 poz.1320), przysługują środki ochrony prawnej w postaci odwołania i skargi do sądu, na zasadach określonych w Dziale IX ustawy  (art. 506-576).</cbc:Description>
            </cac:PresentationPeriod>
            <cac:AppealReceiverParty>
               <cac:PartyIdentification>
                  <cbc:ID>ORG-0002</cbc:ID>
               </cac:PartyIdentification>
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         </cac:AppealTerms>
         <cac:Language>
            <cbc:ID>POL</cbc:ID>
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            <cbc:ElectronicOrderUsageIndicator>false</cbc:ElectronicOrderUsageIndicator>
            <cbc:ElectronicPaymentUsageIndicator>false</cbc:ElectronicPaymentUsageIndicator>
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      </cac:TenderingTerms>
      <cac:TenderingProcess>
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         <cbc:AccessToolsURI>https://dcopih.ezamawiajacy.pl/pn/DCOPIH/demand/309704/notice/public/details</cbc:AccessToolsURI>
         <cac:TenderSubmissionDeadlinePeriod>
            <cbc:EndDate>2026-10-06+02:00</cbc:EndDate>
            <cbc:EndTime>11:30:00+02:00</cbc:EndTime>
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         <cac:OpenTenderEvent>
            <cbc:OccurrenceDate>2026-10-06+02:00</cbc:OccurrenceDate>
            <cbc:OccurrenceTime>12:00:00+02:00</cbc:OccurrenceTime>
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               <cbc:Description languageID="POL">https://dcopih.ezamawiajacy.pl/pn/DCOPIH/demand/309704/notice/public/details</cbc:Description>
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         <cac:ContractingSystem>
            <cbc:ContractingSystemTypeCode listName="dps-usage">none</cbc:ContractingSystemTypeCode>
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      </cac:TenderingProcess>
      <cac:ProcurementProject>
         <cbc:ID schemeName="InternalID">Zadanie nr 31</cbc:ID>
         <cbc:Name languageID="POL">Belantamab mafodotin
</cbc:Name>
         <cbc:Description languageID="POL">fiol. 100 mg/6ml
</cbc:Description>
         <cbc:ProcurementTypeCode listName="contract-nature">supplies</cbc:ProcurementTypeCode>
         <cac:MainCommodityClassification>
            <cbc:ItemClassificationCode listName="cpv">33600000</cbc:ItemClassificationCode>
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            <cbc:Description languageID="POL">Główne miejsce realizacji zamówienia: Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii (DCOPiH) - Apteka 1 - 53-413 Wrocław, pl. Hirszfelda 12; Apteka 2 - ul. Grabiszyńska 105 53-439 Wrocław.
</cbc:Description>
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               <cbc:StreetName>Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii</cbc:StreetName>
               <cbc:AdditionalStreetName>Pl. Hirszfelda 12</cbc:AdditionalStreetName>
               <cbc:CityName>Wrocław</cbc:CityName>
               <cbc:PostalZone>53-413</cbc:PostalZone>
               <cbc:CountrySubentityCode listName="nuts">PL514</cbc:CountrySubentityCode>
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            <cbc:DurationMeasure unitCode="MONTH">12</cbc:DurationMeasure>
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</ContractNotice>