{"id":19738,"contractFolderID":"f151d02f-b42b-4969-8701-6357b71d1756","noticeNumber":"2025-019738","eFormsId":"f1f024f7-15c2-4850-88c5-a65fed652c7c","procedureId":12227,"hideFromOrganisationUsersWhileDraft":false,"datePublished":"2025-01-29T08:05:03.8508864Z","hilmaState":3,"hilmaErrorState":0,"tedState":5,"tedPublicationId":"62019-2025","esentoolNotice":{"id":"f1f024f7-15c2-4850-88c5-a65fed652c7c","versionId":"01","procedureId":"f151d02f-b42b-4969-8701-6357b71d1756","status":"PUBLISHED","updatedAt":"2025-01-29T07:47:34+00:00","submittedAt":"2025-01-28T08:17:10+00:00","publicationId":"62019-2025","publicationDate":"2025-01-29T00:00:00+00:00","noticeType":"29","legalBasis":"32014L0024","languages":["FIN"]},"espdRequestReferences":[],"validationStates":[],"eForm":{"regulatoryDomain":[{"value":"32014L0024"}],"noticeTypeCode":{"listName":"result","value":"can-standard"},"contractFolderID":{"value":"f151d02f-b42b-4969-8701-6357b71d1756"},"issueDate":{"value":"2025-01-28+00:00"},"issueTime":{"value":"08:17:10+00:00"},"procurementProjectLot":[{"procurementProject":{"name":[{"languageID":"FIN","value":"Baloxavir marboxil 40 mg tabletit"}],"id":{"schemeName":"InternalID","value":"THL/6361/2.02.06/2024"},"procurementTypeCode":{"listName":"contract-nature","value":"supplies"},"description":[{"languageID":"FIN","value":"Hankinnan kohteena on Baloxavir marboxil 40 mg tabletit. Kyseessä on kertahankinta ja tuote tulee Suomen rescEU CBRN -varastointihankkeen käyttöön.\n\nArvioidun määrän lisäksi THL:lla on oikeus ostaa tuotetta 100 % arvioidun määrän lisäksi (\"Optio\").\n\nHankinnan kokonaisarvo on 4 120 000 euroa optio mukaan lukien.\n\nHankintayksikkö hankkii lääkevalmistetta hankintalain mukaisena suorahankintana valitulta toimittajalta. Vain tietty toimittaja voi toteuttaa hankinnan."}],"additionalCommodityClassification":[{"itemClassificationCode":{"listName":"cpv","value":"33600000"}}],"mainCommodityClassification":[{"itemClassificationCode":{"listName":"cpv","value":"33651400"}}],"realizedLocation":[{"address":{"country":{"identificationCode":{"listName":"country","value":"FIN"}},"region":{"value":"anyw-cou"}}}]},"id":{"schemeName":"Lot","value":"LOT-0000"},"procurementIdentifier":"QQ/25/012227/000","tenderingProcess":{"governmentAgreementConstraintIndicator":{"value":true},"auctionTerms":{"auctionConstraintIndicator":{"value":false}},"contractingSystem":[{"contractingSystemTypeCode":{"listName":"dps-usage","value":"none"}},{"contractingSystemTypeCode":{"listName":"framework-agreement","value":"none"}}]},"tenderingTerms":{"awardingTerms":{"awardingCriterion":[{"subordinateAwardingCriterion":[{"ublExtensions":[{"extensionContent":{"eformsExtension":{"awardCriterionParameter":[{"parameterCode":{"listName":"number-fixed","value":"fix-tot"},"parameterNumeric":{"value":100.0}}]}}}],"description":[{"languageID":"FIN","value":"Kiinteä arvo"}],"awardingCriterionTypeCode":{"listName":"award-criterion-type","value":"price"},"name":[{"languageID":"FIN","value":"Kiinteä arvo"}]}]}]},"fundingProgramCode":{"listName":"eu-funded","value":"eu-funds"},"appealTerms":{"appealReceiverParty":{"partyIdentification":[{"id":{"schemeName":"organization","value":"ORG-0001"}}]}}}}],"contractingParty":[{"contractingActivity":[{"activityTypeCode":{"listName":"authority-activity","value":"health"}}],"contractingPartyType":[{"partyTypeCode":{"listName":"buyer-legal-type","value":"cga"}}],"party":{"partyIdentification":[{"id":{"schemeName":"organization","value":"ORG-0003"}}],"serviceProviderParty":[{"serviceTypeCode":{"listName":"organisation-role","value":"ted-esen"},"party":{"partyIdentification":[{"id":{"schemeName":"organization","value":"ORG-0004"}}]}}]}}],"tenderingProcess":{"procedureCode":{"listName":"procurement-procedure-type","value":"neg-wo-call"},"processJustification":[{"processReasonCode":{"listName":"direct-award-justification","value":"technical"},"processReason":[{"languageID":"FIN","value":"Kyseessä on lain julkisista hankinnoista ja käyttöoikeussopimuksista (1397/2016, myöhemmin ’hankintalaki’) 26 §:n mukaisen EU-kynnysarvon ylittävä hankinta. Hankintalain 40 §:n 1 momentin 2 kohdan nojalla hankintayksikkö voi valita suorahankinnan, jos teknisestä tai yksinoikeuden suojaamiseen liittyvästä syystä vain tietty toimittaja voi toteuttaa hankinnan; lisäedellytyksenä on, että järkeviä vaihtoehtoisia tai korvaavia ratkaisuja ei ole eikä kilpailun puuttuminen johdu hankinnan ehtojen keinotekoisesta kaventamisesta.\n\nMarkkinaoikeuden ratkaisussa MaO 135/2023 on todettu, että: ”vakiintuneen oikeuskäytännön mukaan hankintayksiköllä on laaja harkintavalta sen määritellessä hankinnan kohdetta. Hankintayksikön ei lähtökohtaisesti tarvitse sovittaa hankinnan kohteelle asettamiaan vaatimuksia markkinoilla tarjolla olevien laitteiden ominaisuuksiin”.\n\nHankintayksikkö (THL Lääketukkukauppa) sai Euroopan Komissiolta pyynnön hankkia, osana rescEU hanketta, baloxavir marboxil lääkevalmistetta. Lääkevalmiste on influenssa A- ja B hoitoon tarkoitettu CAP-riippuvaisen endonukleaasin estäjä. rescEU lääkevalmisteen laatuvaatimuksiksi on määritetty täytäntöönpanopäätöksen 2019/570 Annex 6 mukaisesti kolme rinnakkaista ehtoa, joista ensisijainen vaihtoehto on Euroopan lääkeviraston antama myyntilupa. EU-direktiivin, Suomen lain ja täytäntöönpanopäätöksen perusteella rescEU-lääkevalmisteeksi kelpaa vain EU:ssa myyntiluvallinen tuote, jos sellainen on saatavilla, sillä täytäntöönpanopäätöksen kaksi muuta ehtoa (erityisluvallinen käyttöä ja yhden jäsenvaltion kansallisen sääntelyviraston hyväksyntä) eivät täyty, kun myyntiluvallinen tuote on saatavilla.\n\nHankintayksikön tekemän perusteellisen markkinakartoituksen jälkeen selvityksen lopputulos oli, että EU/EEA:ssa on vain yksi myyntiluvallinen baloxavir marboxil lääkevalmiste, kauppanimeltään Xofluza. Tuotteella on EMA:n keskitetty myyntilupa, ja myyntiluvan haltija on Roche Registration GmbH. Kyseinen tuote rescEU-varastoon hankitaan suorahankintana Roche Registration GmbH:n tytäryhtiöltä Roche Oy:ltä, sillä muita vaatimukset täyttäviä mahdollisia tuotteita tai korvaavia ratkaisuja ei markkinoilla tällä hetkellä ole. Kilpailun puuttuminen ei johdu hankinnan ehtojen keinotekoisesta kaventamisesta."}]}],"noticeDocumentReference":[{"id":{"schemeName":"notice-id-ref","value":"b1caf0fa-7f6e-4f29-a3c2-dba8cd0b94e6-01"}}]},"ublExtensions":[{"extensionContent":{"eformsExtension":{"noticeResult":{"lotResult":[{"tenderLot":{"id":{"schemeName":"Lot","value":"LOT-0000"}},"tenderResultCode":{"listName":"winner-selection-status","value":"selec-w"},"receivedSubmissionsStatistics":[{"statisticsNumeric":{"value":1.0},"statisticsCode":{"listName":"received-submission-type","value":"tenders"}}],"payerParty":[{"partyIdentification":[{"id":{"schemeName":"organization","value":"ORG-0003"}}]}],"settledContract":[{"id":{"schemeName":"contract","value":"CON-0001"}}],"lotTender":[{"id":{"schemeName":"tender","value":"TEN-0001"}}],"id":{"schemeName":"result","value":"RES-0001"}}],"lotTender":[{"id":{"schemeName":"tender","value":"TEN-0001"},"tenderLot":[{"id":{"schemeName":"Lot","value":"LOT-0000"}}],"subcontractingTerm":[{"termCode":{"listName":"applicability","value":"no"}}],"tenderReference":[{"id":{"value":"1"}}],"legalMonetaryTotal":{"payableAmount":{"currencyID":"EUR","value":4120000.0}},"tenderingParty":[{"id":{"schemeName":"tendering-party","value":"TPA-0001"}}]}],"settledContract":[{"issueDate":{"value":"2025-01-21Z"},"awardDate":{"value":"2024-12-02Z"},"contractReference":[{"id":{"value":"THL/6361/2.02.06/2024"}}],"lotTender":[{"id":{"schemeName":"tender","value":"TEN-0001"}}],"funding":[{"financingIdentifier":{"value":"rescEU-CBRNSTOCK-FI"},"description":[{"languageID":"FIN","value":"rescEU - CBRN Stockpiling in Finland"}],"fundingProgramCode":{"listName":"eu-programme","value":"RESCEU"}}],"signatoryParty":[{"partyIdentification":[{"id":{"schemeName":"organization","value":"ORG-0003"}}]}],"id":{"schemeName":"contract","value":"CON-0001"},"procurementIdentifier":"QQ/25/012227/CON001"}],"totalAmount":{"currencyID":"EUR","value":4120000.0},"tenderingParty":[{"tenderer":[{"id":{"schemeName":"organization","value":"ORG-0002"}}],"id":{"schemeName":"tendering-party","value":"TPA-0001"}}]},"organizations":{"organization":[{"company":{"postalAddress":{"countrySubentityCode":{"listName":"nuts","value":"FI1B1"},"streetName":{"value":"Radanrakentajantie 5"},"postalZone":{"value":"00520"},"cityName":{"value":"Helsinki"},"country":{"identificationCode":{"listName":"country","value":"FIN"}}},"partyName":[{"name":{"languageID":"FIN","value":"Markkinaoikeus"}}],"partyLegalEntity":[{"companyID":{"value":"3006157-6","schemeID":"002"}}],"contact":{"telephone":{"value":"+358 295643300"},"electronicMail":{"value":"markkinaoikeus@oikeus.fi"}},"websiteURI":{"value":"http://www.oikeus.fi/markkinaoikeus"},"partyIdentification":{"id":{"schemeName":"organization","value":"ORG-0001"}}}},{"company":{"postalAddress":{"countrySubentityCode":{"listName":"nuts","value":"FI1B1"},"streetName":{"value":"Revontulenpuisto 2 C"},"postalZone":{"value":"02100"},"cityName":{"value":"Espoo"},"country":{"identificationCode":{"listName":"country","value":"FIN"}}},"partyName":[{"name":{"languageID":"FIN","value":"Roche Oy"}}],"partyLegalEntity":[{"companyID":{"value":"0498521-4","schemeID":"002"}}],"contact":{"telephone":{"value":"010 554 500"},"electronicMail":{"value":"janina.haapaniemi@roche.com"}},"partyIdentification":{"id":{"schemeName":"organization","value":"ORG-0002"}}}},{"company":{"postalAddress":{"countrySubentityCode":{"listName":"nuts","value":"FI1B1"},"streetName":{"value":"PL 30"},"postalZone":{"value":"00271"},"cityName":{"value":"Helsinki"},"country":{"identificationCode":{"listName":"country","value":"FIN"}}},"partyName":[{"name":{"languageID":"FIN","value":"Terveyden ja hyvinvoinnin laitos"}}],"partyLegalEntity":[{"companyID":{"value":"2229500-6","schemeID":"002"}}],"contact":{"telephone":{"value":"+358 295246000"},"electronicMail":{"value":"kilpailutus@thl.fi"},"name":{"value":"Keskitetty hankintatoimi"}},"websiteURI":{"value":"http://www.thl.fi/"},"partyIdentification":{"id":{"schemeName":"organization","value":"ORG-0003"}}},"awardingCPBIndicator":{"value":false},"acquiringCPBIndicator":{"value":false}},{"company":{"postalAddress":{"countrySubentityCode":{"listName":"nuts","value":"FI1B1"},"streetName":{"value":"Mannerheiminaukio 1a"},"postalZone":{"value":"00100"},"cityName":{"value":"Helsinki"},"country":{"identificationCode":{"listName":"country","value":"FIN"}}},"partyName":[{"name":{"languageID":"FIN","value":"Hansel Oy (Hilma)"}}],"partyLegalEntity":[{"companyID":{"value":"FI09880841","schemeID":"002"}}],"contact":{"telephone":{"value":"029 55 636 30"},"electronicMail":{"value":"tekninen@hankintailmoitukset.fi"},"name":{"value":"eSender"}},"websiteURI":{"value":"http://hankintailmoitukset.fi"},"partyIdentification":{"id":{"schemeName":"organization","value":"ORG-0004"}}}}]},"transmissionDate":{"value":"2025-01-28+00:00"},"transmissionTime":{"value":"08:18:08+00:00"},"noticeSubType":{"subTypeCode":{"listName":"notice-subtype","value":"29"}}}}}],"procurementProject":{"name":[{"languageID":"FIN","value":"Baloxavir marboxil 40 mg tabletit"}],"id":{"schemeName":"InternalID","value":"THL/6361/2.02.06/2024"},"procurementTypeCode":{"listName":"contract-nature","value":"supplies"},"description":[{"languageID":"FIN","value":"Hankinnan kohteena on Baloxavir marboxil 40 mg tabletit. Kyseessä on kertahankinta ja tuote tulee Suomen rescEU CBRN -varastointihankkeen käyttöön.\n\nArvioidun määrän lisäksi THL:lla on oikeus ostaa tuotetta 100 % arvioidun määrän lisäksi (\"Optio\").\n\nHankinnan kokonaisarvo on 4 120 000 euroa optio mukaan lukien.\n\nHankintayksikkö hankkii lääkevalmistetta hankintalain mukaisena suorahankintana valitulta toimittajalta. Vain tietty toimittaja voi toteuttaa hankinnan."}],"additionalCommodityClassification":[{"itemClassificationCode":{"listName":"cpv","value":"33600000"}}],"mainCommodityClassification":[{"itemClassificationCode":{"listName":"cpv","value":"33651400"}}],"realizedLocation":[{"address":{"country":{"identificationCode":{"listName":"country","value":"FIN"}},"region":{"value":"anyw-cou"}}}]},"id":{"schemeName":"notice-id","value":"f1f024f7-15c2-4850-88c5-a65fed652c7c"},"noticeLanguageCode":{"value":"FIN"},"versionID":{"value":"01"},"ublVersionID":{"value":"2.3"},"customizationID":{"value":"eforms-sdk-1.10"},"tenderResult":[{"awardDate":{"value":"2000-01-01Z"}}]},"hilmaStatistics":{"LOT-0000":{"energyEfficiencyConsidered":false,"lowCarbon":false,"circularEconomy":false,"biodiversity":false,"sustainableFoodProduction":false,"justWorkingConditions":false,"employmentCondition":false,"codeOfConduct":false,"innovationConsidered":false,"solutionNewToBuyer":false,"solutionNewToMarketOrIndustry":false,"smeParticipationConsidered":false,"validationState":0}},"etsCreator":{"id":"0b1adeb0-4928-43f0-3965-08dbb81564ad","name":"Cloudia Kilpailutus"},"isUIReadOnly":true,"tendering":2,"requirements":[],"links":[],"attachments":[],"linkedNotices":["739236-2024"],"isDpsCan":false,"isFrameworkAgreement":null,"isFrameworkAgreementCan":false,"hasReferenceToProcedure":null,"originalSdkVersion":"eforms-sdk-1.10","dateCreated":"2025-01-28T08:33:09.3290513Z","dateModified":"2025-01-29T08:05:03.855Z"}