Productization of Pharmacovigilans (PV)

Läkemedelsverket

The Swedish Medical Products Agency intends to productize and customize existing IT support for the management of adverse reactions and signals for human medicine and veterinary medicine.
The Swedish Medical Products Agency (SMPA), together with the Danish Medicines Agency (DKMA) have established a horizontal collaboration regarding development, use and maintenance of a joint Pharmacovigilance Solution in order to fulfil their respective obligations under EU regulation as National Competent Agencies with respect to performance of pharmacovigilance activities. In the work on tenders and on the execution of the procured bid, the Swedish Medical Products Agency (SMPA) will act as coordinator and provide leadership in completion of the work procured.

Sista ansökningsdag

Tidsfristen för mottagande av anbud var 2021-12-06. Upphandlingen offentliggjordes den 2021-11-18.

Leverantörer

Följande leverantörer nämns i tilldelningsbeslut eller andra upphandlingsdokument:

Vem? Vad? Var?
Upphandlingshistorik
Datum Dokument
2021-11-18 Meddelande om upphandling
2021-12-02 Ytterligare upplysningar
2022-01-13 Meddelande om tilldelning
2022-02-28 Meddelande om tilldelning
Meddelande om upphandling (2021-11-18)
Objekt
Upphandlingens omfattning
Titel: Programvaruutvecklingstjänster för särskild industri
Referensnummer: 2.3.1-2021-075721
Kort beskrivning:
The Swedish Medical Products Agency intends to productize and customize existing IT support for the management of adverse reactions and signals for human medicine and veterinary medicine. The Swedish Medical Products Agency (SMPA), together with the Danish Medicines Agency (DKMA) have established a horizontal collaboration regarding development, use and maintenance of a joint Pharmacovigilance Solution in order to fulfil their respective obligations under EU regulation as National Competent Agencies with respect to performance of pharmacovigilance activities. In the work on tenders and on the execution of the procured bid, the Swedish Medical Products Agency (SMPA) will act as coordinator and provide leadership in completion of the work procured.
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Meddelandeinformation
Originalspråk: engelska 🗣️
Dokumenttyp: Meddelande om upphandling
Kontraktets art: Tjänster
Reglering: Europeiska unionen – inom ramen för avtalet om offentlig upphandling
Gemensam upphandlingsterminologi (CPV)
Kod: Programvaruutvecklingstjänster för särskild industri 📦
Ytterligare CPV-kod: Medicinsk programvara 📦
Plats för genomförandet
NUTS-region: Uppsala län 🏙️

Förfarande
Förfarandetyp: Öppet förfarande
Anbudstyp: Anbud på alla delar
Kriterier för tilldelning
Det ekonomiskt mest fördelaktiga

Upphandlande myndighet
Identitet
Land: Sverige 🇸🇪
Upphandlande myndighet (typ): Statligt verk
Upphandlande myndighet (namn): Läkemedelsverket
Postadress: Box 26
Postnummer: 75103
Postort: Uppsala
Kontakt
Webbadress: http://www.lakemedelsverket.se 🌏
E-post: stefan.palm@lakemedelsverket.se 📧
URL för dokument: https://tendsign.com/doc.aspx?UniqueId=afoqozbxxy&GoTo=Docs 🌏
URL för deltagande: https://tendsign.com/doc.aspx?UniqueId=afoqozbxxy&GoTo=Tender 🌏

Referens
Datum
Avsändningsdatum: 2021-11-18 📅
Sista anbudsdag: 2021-12-06 📅
Publiceringsdatum: 2021-11-23 📅
Startdatum: 2022-01-03 📅
Slutdatum: 2024-01-02 📅
Identifierare
Meddelandenummer: 2021/S 227-597618
EUT-S-nummer: 227
Ytterligare information
Mercell notice: https://opic.com/id/afoqozbxxy

Objekt
Upphandlingens omfattning
Kort beskrivning:
The Swedish Medical Products Agency intends to productize and customize existing IT support for the management of adverse reactions and signals for human medicine and veterinary medicine.
The Swedish Medical Products Agency (SMPA), together with the Danish Medicines Agency (DKMA) have established a horizontal collaboration regarding development, use and maintenance of a joint Pharmacovigilance Solution in order to fulfil their respective obligations under EU regulation as National Competent Agencies with respect to performance of pharmacovigilance activities. In the work on tenders and on the execution of the procured bid, the Swedish Medical Products Agency (SMPA) will act as coordinator and provide leadership in completion of the work procured.
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Invitation
The Swedish Medical Products Agency (SMPA), together with the Danish Medicines Agency (DKMA) have established a horizontal collaboration regarding development, use and maintenance of a joint Pharmacovigilance Solution in order to fulfil their respective obligations under EU regulation as National Competent Agencies with respect to performance of pharmacovigilance activities. As part of the collaboration SMPA shall provide the Background System serving as the basis the of joint development.
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SMPA, acting in its own name and on behalf of DKMA, invites interested suppliers to submit a bid for the procurement of IT consultancy services for the purpose of enabling the Background system to act as a joint platform for the collective and individual needs of several National Competent Agencies (Productization). In the work on tenders and on the execution of the procured bid, the Swedish Medical Products Agency (SMPA) will act as coordinator and provide leadership in completion of the work procured.
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The procurement will apply only to the productization and adaptation of the Background system for collective use by the members of the Consortium (at present SMPA and DKMA). DKMA will need an interim solution (DKMA MVP) to go live 30th June 2022. This means that this procurement does not include work or services related to development or maintenance of the SMPA pharmacovigilance system used as the Background system, which are covered by the procurement awarded by SMPA in 2019 (see contract notice 2019/S071-167957).
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Plats för genomförandet
Huvudort eller plats för utförandet: Uppsala

Förfarande
Rättslig grund: 32014L0024
Förskjutet förfarande: Prior information notice 2021/S 197-512930 sent October 6, 2021.
Tidpunkt för mottagande av anbud: 23:59
Språk på vilka anbud eller ansökningar om deltagande kan lämnas in: engelska 🗣️
Anbudens giltighetstid: 2022-06-06 📅
Datum för öppnande av anbud: 2021-12-07 📅
Tidpunkt för öppnande av anbud: 13:00

Upphandlande myndighet
Identitet
Nationellt registreringsnummer: 202100-4078
Kontakt
Kontaktpunkt: Stefan Palm
URL för dokument: https://tendsign.com/doc.aspx?UniqueId=afoqozbxxy&GoTo=Docs 🌏

Kompletterande information
Granskningsorgan
Namn: Förvaltningsrätten i Uppsala
Postort: Uppsala
Land: Sverige 🇸🇪
Källa: OJS 2021/S 227-597618 (2021-11-18)
Ytterligare upplysningar (2021-12-02)
Objekt
Meddelandeinformation
Dokumenttyp: Ytterligare upplysningar
Gemensam upphandlingsterminologi (CPV)
Kod: Medicinska programvaruutvecklingstjänster 📦

Referens
Datum
Avsändningsdatum: 2021-12-02 📅
Sista anbudsdag: 2021-12-13 📅
Publiceringsdatum: 2021-12-07 📅
Identifierare
Meddelandenummer: 2021/S 237-625364
Refererar till meddelande: 2021/S 227-597618
EUT-S-nummer: 237
Ytterligare information
Mercell notice: https://opic.com/id/afzwlayrrb
Källa: OJS 2021/S 237-625364 (2021-12-02)
Meddelande om tilldelning (2022-01-13)
Objekt
Meddelandeinformation
Dokumenttyp: Meddelande om tilldelning

Förfarande
Anbudstyp: Ej tillämpligt
Kriterier för tilldelning
Lägsta pris

Referens
Datum
Avsändningsdatum: 2022-01-13 📅
Publiceringsdatum: 2022-01-18 📅
Identifierare
Meddelandenummer: 2022/S 012-027412
EUT-S-nummer: 12
Ytterligare information
Motivation for cancelling No tenders. Mercell notice: https://opic.com/id/afoujwyiwq
Motivation for cancelling
No tenders.
Källa: OJS 2022/S 012-027412 (2022-01-13)
Meddelande om tilldelning (2022-02-28)
Objekt
Upphandlingens omfattning
Referensnummer: 2022021688
Kort beskrivning:
The Swedish Medical Products Agency (SMPA), together with the Danish Medicines Agency (DKMA) have established a horizontal collaboration regarding development, use and maintenance of a joint Pharmacovigilance Solution in order to fulfil their respective obligations under EU regulation as National Competent Agencies with respect to performance of pharmacovigilance activities. For this contract and on the execution of the procured bid, the DKMA will act as coordinator and provide leadership in completion of the work procured. The SMPA and the DKMA intends to productize and customize existing IT support for the management of adverse reactions and signals for human medicine and veterinary medicine. This contract has previously been published by the SMPA where it unfortunately did not attract any bidders and therefore we have now awarded it by means of a negotiated procedure.
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Upphandlingens totala värde: 21 000 000 DKK 💰
Plats för genomförandet
NUTS-region: Byen København 🏙️

Förfarande
Förfarandetyp: Förhandlat förfarande utan meddelande om upphandling

Upphandlande myndighet
Identitet
Land: Danmark 🇩🇰
Upphandlande myndighet (typ): Ministerium eller annan central
Upphandlande myndighet (namn): Lægemiddelstyrelsen
Postadress: Axel Heides Gade 1
Postnummer: DK-2300
Postort: Copenhagen S
Kontakt
Webbadress: http://www.lmst.dk 🌏
E-post: trm@dkma.dk 📧
Telefon: +45 44889344 📞

Referens
Datum
Avsändningsdatum: 2022-02-28 📅
Publiceringsdatum: 2022-03-04 📅
Identifierare
Meddelandenummer: 2022/S 045-116658
EUT-S-nummer: 45
Ytterligare information
The value of the contract stated in V.2.4 is the maximum figure based on the previously tendered contract, including options.

Objekt
Upphandlingens omfattning
Kort beskrivning:
The Swedish Medical Products Agency (SMPA), together with the Danish Medicines Agency (DKMA) have established a horizontal collaboration regarding development, use and maintenance of a joint Pharmacovigilance Solution in order to fulfil their respective obligations under EU regulation as National Competent Agencies with respect to performance of pharmacovigilance activities. For this contract and on the execution of the procured bid, the DKMA will act as coordinator and provide leadership in completion of the work procured.
Visa mer
The SMPA and the DKMA intends to productize and customize existing IT support for the management of adverse reactions and signals for human medicine and veterinary medicine. This contract has previously been published by the SMPA where it unfortunately did not attract any bidders and therefore we have now awarded it by means of a negotiated procedure.
Visa mer
The procurement will apply only to the productization and adaptation of the Background system for collective use by the members of the Consortium (at present SMPA and DKMA). DKMA will need an interim solution (DKMA MVP) to go live 30th June 2022. This means that the basic procurement without options does not include work or services related to development or maintenance of the SMPA pharmacovigilance system used as the Background system, which are covered by the procurement awarded by SMPA in 2019 (see contract notice 2019/S071-167957).
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Beskrivning av alternativen:
Further productization and adaptation of the Background system, beyond the DKMA MVP referenced in II.2.4.

Förfarande
Tillämplig upphandlingslagstiftning: Swedish law

Tilldelning av kontrakt
Datum för avtalstecknande: 2022-02-04 📅
Namn: Isife ApS
Nationellt registreringsnummer: 38819259
Postort: Søborg
Postnummer: 2860
Land: Danmark 🇩🇰
Københavns omegn 🏙️
Upphandlingens totala värde: 21 000 000 DKK 💰
Information om anbud
Antal mottagna anbud: 3

Upphandlande myndighet
Identitet
Nationellt registreringsnummer: 37052485
Upphandlande myndighet (namn): Swedish Medical Products Agency
Land: Uppsala län 🏙️
Kontakt
Kontaktpunkt: Troels Mogensen
Webbadress: https://www.lakemedelsverket.se/en 🌏
Källa: OJS 2022/S 045-116658 (2022-02-28)
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