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    <cbc:Note languageID="HRV">Ovlaštenje koje je gospodarskom subjektu potrebno u zemlji sjedišta za obavljanje djelatnosti vezano s predmetom nabave:
  1. Posjedovanje određenog ovlaštenja odnosi se na Rješenje o davanju dozvole za promet lijekovima na veliko izdano od Agencije ili dozvola za promet  na veliko lijekovima izdana od nadležnog tijela druge države članice EU, uz dokaz prijave Agenciji početka obavljanja djelatnosti na području Republike Hrvatske
2.  Odobrenje za stavljanje lijeka u promet u Republici Hrvatskoj koju izdaje Agencija ili Europska komisija, sukladno članku 113. Zakona o lijekovima (NN 76/13 i 90/14.)
Za cjepivo za koje nije dano odobrenje  u Republici Hrvatskoj ponuditelj dostavlja Izjavu da će ishoditi suglasnost  a sve sukladno članku 129.  Zakona o lijekovima (NN 76/13. i 90/14.)
Naručitelj će prije donošenja Odluke o odabiru, od ponuditelja koji dostavi ekonomski najpovoljniju ponudu zatražiti da u roku od pet (5) dana dostavi tražene dokumente.
Ukoliko odabrani ponuditelj u roku od 5 (pet) dana ne dostavi tražene dokumente temeljem pisanog zahtjeva naručitelja, ponuda ponuditelja biti će odbijena kao neprikladna ponuda jer ne zadovoljava zahtjeve naručitelja propisane dokumentacijom o nabavi.
Suglasnost za unos ili uvoz lijeka za koji nije dano odobrenje za stavljanje u promet u Republici Hrvatskoj pripada izvanrednom postupku koji HALMED provodi temeljem članka 129. Zakona o lijekovima.</cbc:Note>
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U bankarskoj garanciji mora biti navedeno sljedeće:
- da je korisnik garancije Hrvatski zavod za javno zdravstvo, Rockefellerova 7, Zagreb
- da se garant obvezuje neopozivo, bezuvjetno na "prvi poziv" korisnika garancije, "bez prigovora", isplatiti iznos od 4.900,00,00 EUR. 
U bankarskoj garanciji također moraju biti navedeni svi slučajevi u kojima će Naručitelj zadržati jamstvo za ozbiljnost ponude (odustanjanja ponuditelja od svoje ponude u roku njezine valjanosti, nedostavljanja ažuriranih popratnih dokumenata sukladno čl.263. ZJN, neprihvaćanja ispravka računske pogreške odbijanja potpisivanja okvirnog sporazuma/ugovora, nedostavljanja jamstva za uredno ispunjenje ugovora . 
Rok valjanosti garancije mora biti najmanje do dana isteka valjanosti ponude. Ako istekne rok valjanosti ponude ili jamstva za ozbiljnost ponude, naručitelj će tražiti njihovo produženje. U tu svrhu ponuditelju će se dati primjeren rok. Bankarska garancija dostavlja se u izvorniku.
U slučaju da ponuditelj dostavlja Bjanko zadužnicu, ista mora biti dostavljena u odgovarajućem broju primjeraka, ispunjena, potpisana i ovjerena prema Pravilniku o obliku i sadržaju bjanko zadužnice (NN 115/12 i 82/17).
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