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:
Objekt Upphandlingens omfattning
Titel: Productization of Pharmacovigilans (PV)
2.3.1-2021-075721
Produkter/tjänster: Programvaruutvecklingstjänster för särskild industri📦
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...”
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.
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.
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.
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.
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).
Visa mer Kriterier för tilldelning
Priset är inte det enda tilldelningskriteriet och alla kriterier anges endast i upphandlingsdokumenten
Varaktighet
Startdatum: 2022-01-03 📅
Slutdatum: 2024-01-02 📅
Förfarande Typ av förfarande
Öppet förfarande
Förskjutet förfarande: Prior information notice 2021/S 197-512930 sent October 6, 2021.
Administrativ information
Tidsfrist för mottagande av anbud eller begäran om deltagande: 2021-12-06
23:59 📅
Språk på vilka anbud eller ansökningar om deltagande kan lämnas in: engelska 🗣️
Anbudet skall vara giltigt till och med: 2022-06-06 📅
Villkor för öppnande av anbud: 2021-12-07
13:00 📅
Kompletterande information Ytterligare information
Mercell notice: https://opic.com/id/afoqozbxxy Granskningsorgan
Namn: Förvaltningsrätten i Uppsala
Postort: Uppsala
Land: Sverige 🇸🇪
Källa: OJS 2021/S 227-597618 (2021-11-18)
Ytterligare upplysningar (2021-12-02)
Kompletterande information Ursprunglig referens till meddelandet
Nummer på meddelandet i EUT S: 2021/S 227-597618
Ändringar Text som skall rättas i det ursprungliga meddelandet
Avsnittets nummer: IV.2.2)
Plats för den text som ska ändras: Time limit for receipt of tenders or requests to participate
Gammalt värde
Datum: 2021-12-06 📅
Tid: 23:59
Nytt värde
Datum: 2021-12-13 📅
Tid: 23:59
Text som skall rättas i det ursprungliga meddelandet
Avsnittets nummer: IV.2.7)
Plats för den text som ska ändras: Conditions for opening of tenders
Gammalt värde
Datum: 2021-12-07 📅
Tid: 13:00
Nytt värde
Datum: 2021-12-14 📅
Tid: 08:00
Annan kompletterande information
Mercell notice: https://opic.com/id/afzwlayrrb
Källa: OJS 2021/S 237-625364 (2021-12-02)
Meddelande om tilldelning (2022-01-13) Objekt Kriterier för tilldelning
Pris
Förfarande Administrativ information
Tidigare publikation om detta förfarande: 2021/S 227-597618
Tilldelning av kontrakt
1️⃣ Information om icke-tilldelning
Inga anbud eller ansökningar om deltagande har mottagits eller alla har förkastats
Kompletterande information Ytterligare information
“Motivation for cancelling
No tenders.
Mercell notice: https://opic.com/id/afoujwyiwq”
Källa: OJS 2022/S 012-027412 (2022-01-13)
Meddelande om tilldelning (2022-02-28) Upphandlande myndighet Namn och adresser
Namn: Lægemiddelstyrelsen
Nationellt registreringsnummer: 37052485
Postadress: Axel Heides Gade 1
Postort: Copenhagen S
Postnummer: DK-2300
Land: Danmark 🇩🇰
Kontaktperson: Troels Mogensen
Telefon: +45 44889344📞
E-post: trm@dkma.dk📧
Region: Hovedstaden 🏙️
URL: http://www.lmst.dk🌏
Upphandlande myndighet (ytterligare)
Namn: Swedish Medical Products Agency
Postort: Uppsala
Kontaktperson: Stefan Palm
Upphandlande myndighet
URL: https://www.lakemedelsverket.se/en🌏 Information om gemensam upphandling
Kontraktet omfattar gemensam upphandling
Vid gemensam upphandling som omfattar olika länder, ange tillämplig nationell upphandlingslagstiftning: Swedish law
Objekt Upphandlingens omfattning
Titel: Productization of Pharmacovigilans (PV)
2022021688
Kort beskrivning:
“The Swedish Medical Products Agency (SMPA), together with the Danish Medicines Agency (DKMA) have established a horizontal collaboration regarding...”
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 (exklusive moms): DKK 21 000 000 💰
Beskrivning
Plats för genomförandet: Byen København 🏙️
Beskrivning av upphandlingen:
“The Swedish Medical Products Agency (SMPA), together with the Danish Medicines Agency (DKMA) have established a horizontal collaboration regarding...”
Beskrivning av upphandlingen
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.
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).
Visa mer Information om alternativen
Alternativ ✅
Beskrivning av alternativen:
“Further productization and adaptation of the Background system, beyond the DKMA MVP referenced in II.2.4.”
Förfarande Typ av förfarande
Inga anbud eller inga lämpliga anbud/ansökningar om deltagande som svar på ett öppet förfarande
Tilldelning av kontrakt utan föregående offentliggörande av en anbudsinfordran i Europeiska unionens officiella tidning (förklaring):
“DKMA and SMPA have previously twice published the same contract without receiving any bids. The contract includes developing a new pharmacovigilance...”
Tilldelning av kontrakt utan föregående offentliggörande av en anbudsinfordran i Europeiska unionens officiella tidning (förklaring)
DKMA and SMPA have previously twice published the same contract without receiving any bids. The contract includes developing a new pharmacovigilance solution for the DKMA, which will be compatible with the new EU pharmacovigilance regulations nomenclature to be introduced in June 2022, in accordance with regulation EU/520/2012.
Visa mer Information om avslutande av konkurrensutsättning i form av ett förhandsbesked
Den upphandlande myndigheten kommer inte att tilldela några ytterligare kontrakt på grundval av ovanstående förhandsbesked
Tilldelning av kontrakt
Datum för ingående av avtalet: 2022-02-04 📅
Information om anbud
Antal mottagna anbud: 3
Entreprenörens namn och adress
Namn: Isife ApS
Nationellt registreringsnummer: 38819259
Postort: Søborg
Postnummer: 2860
Land: Danmark 🇩🇰
Region: Københavns omegn 🏙️
Entreprenören är ett litet eller medelstort företag ✅ Uppgifter om kontraktets/partiets värde (exklusive moms)
Uppskattat totalt värde på kontraktet/lotten: DKK 21 000 000 💰
Kontraktets/lottens totala värde: DKK 21 000 000 💰
Kompletterande information Ytterligare information
“The value of the contract stated in V.2.4 is the maximum figure based on the previously tendered contract, including options.”
Källa: OJS 2022/S 045-116658 (2022-02-28)