MTU/2013/Project 000695/ Synthesis Module

Helse Bergen HF

Procurement of synthesis module for clinical GMP production of C-11 labelled connections for PET diagnostics, including semi-preparative HPLC. Initially C-11 Methionine shall be manufactured. However, this is not subject to constraint. The synthesis module shall be operated in a clean room environment classification C and shall comply with requirements given by the authority in relation to PET radiopharmacy manufacturing for clinical use, including qualification and validation of the relevant PET radiopharmacy expected to be manufactured.
Note: To register your interest in this notice and obtain any additional information please visit the Doffin Web Site at http://www.doffin.no/Search/Search_Switch.aspx?ID=311693

Frist

Fristen for mottak av tilbud var 2014-01-22. Anskaffelsen ble publisert 2013-11-29.

Hvem? Hva? Hvor?
Anskaffelseshistorikk
Dato Dokument
2013-11-29 Kunngjøring av konkurranse
Kunngjøring av konkurranse (2013-11-29)
Gjenstand
Anskaffelsens omfang
Tittel: Medical equipments
Antall eller omfang:
1 synthesis instrument in accordance with description, including semi-preparative HPLC.
Metadata for kunngjøring
Originalspråk: engelsk 🗣️
Dokumenttype: Kunngjøring av konkurranse
Kontraktens art: Varer
Forskrift: Det europeiske økonomiske samarbeidsområdet (EØS), med deltakelse av GPA-land
Felles innkjøpsordliste (CPV)
Kode: Medisinsk utstyr 📦

Prosedyre
Prosedyretype: Åpen anbudskonkurranse
Tilbudstype: Innlevering for alle delkontrakter
Tildelingskriterier
Det mest økonomisk fordelaktige tilbudet

Oppdragsgiver
Identitet
Land: Norge 🇳🇴
Type tildelende myndighet: Offentligrettslig organ
Navn på tildelende myndighet: Helse Bergen HF
Postadresse: Postboks 1, Haukeland universitetssjukehus, Postboks 1400
Postnummer: 5021
Poststed: Bergen
Kontakt
Internettadresse: http://www.helse-bergen.no 🌏
E-post: aud.bruland@helse-bergen.no 📧
Telefon: +47 55975000 📞

Referanse
Datoer
Sendt dato: 2013-11-29 📅
Innleveringsfrist: 2014-01-22 📅
Publiseringsdato: 2013-12-03 📅
Identifikatorer
Kunngjøringsnummer: 2013/S 234-406866
OJ-S-utgave: 234
Tilleggsinformasjon
(NT Ref:311703)

Gjenstand
Anskaffelsens omfang
Kort beskrivelse:
Procurement of synthesis module for clinical GMP production of C-11 labelled connections for PET diagnostics, including semi-preparative HPLC. Initially C-11 Methionine shall be manufactured. However, this is not subject to constraint. The synthesis module shall be operated in a clean room environment classification C and shall comply with requirements given by the authority in relation to PET radiopharmacy manufacturing for clinical use, including qualification and validation of the relevant PET radiopharmacy expected to be manufactured.
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Note: To register your interest in this notice and obtain any additional information please visit the Doffin Web Site at http://www.doffin.no/Search/Search_Switch.aspx?ID=311693
Utførelsessted
Hovedsted eller utførelsessted: The PET centre, Norway.

Juridisk, økonomisk, finansiell og teknisk informasjon
Vilkår for deltakelse
Egnethet til å utøve yrkesvirksomheten:
(1) Other documentation required (please state below).
The tenderer shall have settled conditions in relation to payment of taxes and VAT.
— Tax certificate.
— Certificate for paid VAT.
Certificates for taxes and paid VAT shall be issued either by the local tax office or the tax collection office where the tenderer's head office is located. These certificates shall not be older than 6 months. See: http://www.skatteetaten.no/Templates/Artikkel.aspx?id=9196&epslanguage=NO.
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— Foreign tenderer shall present certificates from equivalent authorities as the Norwegian.
The tenderer shall have an established HSE system.
— HSE self-declaration, see Annex B.
The tenderer shall be a legally established company.
— Norwegian companies: Company Registration Certificate.
— Foreign companies: Foreign companies shall substantiate that the company is registered in the trade index or the Register of Business Enterprises as required in the legislation where the tenderer is established.
Økonomisk og finansiell stilling:
(1) Other documentation required (please state below)
Credit appraisal/rating, not older than 6 months, which shall be based on the most recent known accounting figures. The rating shall be carried out by a publicly approved credit rating agency. The rating shall as a minimum have score A or higher, based on AAA Soliditet's scale - or equivalent score from other reputable credit rating agencies.
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If the tenderer is unable to present a credit rating, the Awarding Authority will on own initiative obtain this from AAA Soliditet AS.
If the tenderer's credit appraisal is unsubstantial, e.g. recently established companies with credit score AN, satisfactory unreserved guarantees from bank and/or controlling company with sufficient credit appraisal may compensate for this requirement. Suchlike alternative documents shall be attached the tender.
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Minste nivå(er) av standarder:
The tenderer shall have sufficient financial capacity to implement the assignment/comply with the contractual obligations.
Kontraktutførelse
Innskudd og garantier som kreves: See the tender documents.
Hovedfinansieringsvilkår og betalingsordninger og/eller henvisning til relevante bestemmelser som regulerer dem: See the tender documents.

Prosedyre
Tilbudets gyldighetsperiode: 2014-09-01 📅
Språk
Andre språk: Norwegian

Oppdragsgiver
Kontakt
Kontaktpunkt: Prosjektkontoret
Aud Kristiansen Bruland
Adresse til kjøperprofilen: http://www.doffin.no//search/Search_AuthProfile.aspx?ID=AA8255 🌏
Navn: Helse Bergen HF
URL for ytterligere informasjon: http://www.helse-bergen.no 🌏
URL for dokumenter: http://www.helse-bergen.no 🌏
Kilde: OJS 2013/S 234-406866 (2013-11-29)