Solution for eSubmission Management

Statens Legemiddelverk

Procurement of a SaaS solution to handle dossiers connected to applications for marketing licences for medicines - eSubmissions.

Frist

Fristen for mottak av tilbud var 2023-01-27. Anskaffelsen ble publisert 2022-12-22.

Leverandører

Følgende leverandører er nevnt i tildelingsbeslutninger eller andre anskaffelsesdokumenter:

• LORENZ Archiv-Systeme GmbH

Hvem?

• Statens Legemiddelverk

Hva?

Hvor?

• Oslo og Viken › Oslo

Anskaffelseshistorikk

Dato	Dokument
2022-12-22	Kunngjøring av konkurranse
2023-07-26	Kunngjøring om tildeling av kontrakt

Kunngjøring av konkurranse (2022-12-22)
Gjenstand
Anskaffelsens omfang
Tittel: Provider services
Referansenummer: 22/29667
Kort beskrivelse:

Procurement of a SaaS solution to handle dossiers connected to applications for marketing licences for medicines - eSubmissions.

Metadata for kunngjøring
Originalspråk: engelsk 🗣️
Dokumenttype: Kunngjøring av konkurranse
Kontraktens art: Tjenester
Forskrift: Det europeiske økonomiske samarbeidsområdet (EØS), med deltakelse av GPA-land
Felles innkjøpsordliste (CPV)
Kode: Tjenesteleverandør tjenester 📦
Tilleggs-CPV: Bransjespesifikk programvare 📦
Utførelsessted
NUTS-region: Oslo 🏙️

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

Oppdragsgiver
Identitet
Land: Norge 🇳🇴
Type tildelende myndighet: Nasjonalt eller føderalt byrå/kontor
Navn på tildelende myndighet: Statens Legemiddelverk
Postadresse: Grensesvingen 26
Postnummer: 0663
Poststed: Oslo
Kontakt
Internettadresse: https://permalink.mercell.com/193162086.aspx 🌏
E-post: gunnar.carelius@legemiddelverket.no 📧
Telefon: +47 22877900 📞
URL for dokumenter: https://permalink.mercell.com/193162086.aspx 🌏
URL for deltakelse: https://permalink.mercell.com/193162086.aspx 🌏

Referanse
Datoer
Sendt dato: 2022-12-22 📅
Innleveringsfrist: 2023-01-27 📅
Publiseringsdato: 2022-12-27 📅
Identifikatorer
Kunngjøringsnummer: 2022/S 249-728599
OJ-S-utgave: 249

Gjenstand
Anskaffelsens omfang
Estimert totalverdi: 6 000 000 NOK 💰
Kort beskrivelse:

The overall aim of the procurement is to solve the Norwegian Medicines Agency's (NOMA) need for eSubmission management. The procurement is connected to the ongoing process of modernising NOMA's case management systems. The modernisation has uncovered a need to reduce manual work connected to handling the reception, making available, and journaling of dossiers that are submitted for applications for marketing licences (MT) for case management. The existing systems are difficult to continue without a large part of the manual work be transferred from the archive function to executive employees. By introducing a system that both handles loading, validating, and making dossiers available, and which can be integrated with the next generation case management system in NOMA, this problem will be solved:

- To automise the process of receiving, validating, and making dossiers available that are received from CESP, Common Repository, and in the future DADI / PL

- Lay the basis for being able to automise corrections and updates to cases in NOMA's new case management system, DELE

- To facilitate NOMA's executive employees having a suitable and user friendly tool for insight in and processing of all relevant dossiers

- To facilitate the use of eCTD version 4.0

Estimert verdi eksklusive mva: 6 000 000 NOK 💰
Varighet: 36 måneder
Beskrivelse av fornyelser:

The provisions in SSA-L are renewed annually for one year at a time after three years.

Juridisk, økonomisk, finansiell og teknisk informasjon
Vilkår for deltakelse
Egnethet til å utøve yrkesvirksomheten:

Documented by a company registration certificate or equivalent documentation that shows that the tenderer is registered in a register of business enterprises, a trade register, a professional register or a register of commerce in their home country.

Økonomisk og finansiell stilling:

The economic and financial standing must be documented by the following information:

a. The last approved annual accounts with the annual report and the auditor´s report.

b. Solidity assessment from a company with a licence to run a credit information company. The evaluation must not be older than 3 months from the deadline for receipt of tenders. It must be based on the last approved accounting figures and should report on the credit worthiness and degree of bankruptcy risk (bankruptcy prediction).

c. Parent company guarantee (if relevant).

Teknisk og faglig kapasitet:

K3 - Tenderers must have good competence and capacity for the delivery and further development of eSubmission management system.

K3 - Documentation requirement:

a. Description of the tenderer's organisation that is relevant for this delivery.

b. Description of the total competence and capacity that the tenderer has available.

K4 - Tenderers must have relevant experience from equivalent medicine authorities to NOMA.

K4 - Documentation requirement:

Up to three customer references in the last three years.

The references must include, amongst other things,

Automatic downloading from CESP and Common Repository, technical validation, and making available in the offered system

Integration between the offered system and the customer's case management system

Migration of existing eSubmission documents to the offered system

Complete Annex K4 - Customer References

K5 - Tenderers must have established a satisfactory management system for information security (ISMS).

K5 - Documentation requirement:

A copy of an information security certificate (ISO27001/equivalent), issued by an accredited certification bodyies, if relevant.

A description of the tenderer’s ISMS, as well as how it is implemented and managed internally.

The requirement must be fulfilled by both the tenderer and any collaborating companies.

K6 - Tenderers must have a sufficient quality management system established.

K6 - Documentation requirement:

A copy of a quality management certificate (ISO 9001/equivalent), issued by an accredited certification body, if relevant.

A description of the tenderer’s quality management system as well as how it is implemented and managed internally.

Prosedyre
Rettslig grunnlag: 32014L0024
Tidspunkt for mottak av tilbud: 12:00
Språk som tilbud eller forespørsler om deltakelse kan sendes inn på: engelsk 🗣️
norsk 🗣️
Tilbudets gyldighetsperiode: 2023-04-28 📅
Dato for åpning av tilbud: 2023-01-27 📅
Tidspunkt for åpning av tilbud: 12:00
Sted: Oslo

Oppdragsgiver
Identitet
Nasjonalt registreringsnummer: 974761122
Kontakt
Kontaktpunkt: Gunnar Carelius
Adresse til kjøperprofilen: http://www.legemiddelverket.no/ 🌏
URL for dokumenter: https://permalink.mercell.com/193162086.aspx 🌏

Utfyllende informasjon
Klageinstans
Navn: Oslo tingrett
Postadresse: Postboks 2106 Vika
Poststed: Oslo
Postnummer: 0125
Land: Norge 🇳🇴
E-post: oslo.tingrett@domstol.no 📧
Kilde: OJS 2022/S 249-728599 (2022-12-22)

Kunngjøring om tildeling av kontrakt (2023-07-26)
Gjenstand
Anskaffelsens omfang
Totalverdi for anskaffelsen: 12 900 000 NOK 💰
Metadata for kunngjøring
Dokumenttype: Kunngjøring om tildeling av kontrakt

Prosedyre
Tilbudstype: Ikke aktuelt

Referanse
Datoer
Sendt dato: 2023-07-26 📅
Publiseringsdato: 2023-07-31 📅
Identifikatorer
Kunngjøringsnummer: 2023/S 145-464005
Refererer til kunngjøring: 2022/S 249-728599
OJ-S-utgave: 145

Gjenstand
Anskaffelsens omfang
Beskrivelse av opsjoner:

- Migration of data from today's solution

- Validation OQ (Test + PRD)

Prosedyre
Tildelingskriterier
Kvalitetskriterium (navn): The suitability of the offered solution for fulfilling the purpose of the procurement
Kvalitetskriterium (vekting): 70%
Kvalitetskriterium (navn): Described plan for the establishment phase
Kvalitetskriterium (vekting): 15%
Kvalitetskriterium (navn): Described SLA
Pris (vekting): 30%

Tildeling av kontrakt
Dato for kontraktinngåelse: 2023-05-15 📅
Navn: LORENZ Archiv-Systeme GmbH
Postadresse: Eschborner Landstr. 75
Poststed: Frankfurt
Postnummer: 60489
Land: Tyskland 🇩🇪
Telefon: +47 5117133164 📞
E-post: mschremser@lorenz.cc 📧
Land: Frankfurt am Main, Kreisfreie Stadt 🏙️
Internettadresse: https://www.lorenz.cc/index.cfm 🌏
Totalverdi for anskaffelsen: 12 900 000 NOK 💰
Informasjon om tilbud
Antall mottatte tilbud: 3
Kilde: OJS 2023/S 145-464005 (2023-07-26)

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