System for receiving and processing marketing authorisation applications for medical products
Lääkealan turvallisuus- ja kehittämiskeskus Fimea · koko Suomi
Perustiedot
- Suunniteltu julkaisupäivä
- 8.1.2025
- Hankkija
- Lääkealan turvallisuus- ja kehittämiskeskus Fimea, Y-tunnus 0921536-6
- Toteutuspaikka
- koko Suomi
- Hankintalaji
- Palvelu
- Menettely
- EU-hankinta
- Ilmoituksen tyyppi
- Ennakkoilmoitus
- Arvioitu kokonaisarvo
- Ei ilmoitettu
- Erät
- 2 erää
- Pääasiallinen CPV
- 72000000 Tietotekniset palvelut: neuvonta, ohjelmistojen kehittäminen, Internet ja tuki
- Lisäkoodit: 48311000, 48610000, 72260000, 72600000
- Julkaistu
- 1.9.2024
Ilmoituksen teksti
Alkuperäinen teksti Hilmasta, muuttamattomanaThe Finnish Medicines Agency Fimea (later Fimea) is preparing the procurement of a system for receiving and processing marketing authorisation applications for medical products.
Fimea is primarily looking for a software as a service off-the shelf solution that is provided from public cloud. The system shall enable the necessary integrations with Fimea's other systems, which will be defined later.
The procurement will also include support and maintenance services for the system to be procured.
In addition, Fimea is interested in acquiring a system for clinical trials as a part of this procurement (more information on this will be given later).
The purpose of this request for information is to identify potential tenderers and to get an idea of the solutions available on the market. After the market dialogue, a call for tenders for the procurement will be prepared.
Lisätiedot
Please note that this is a prior information notice and not call for tenders. The information provided in this notice is preliminary and is subject to change during preparation. Answering or not answering to this request for information shall not preclude participation in a possible tendering that is planned to start in end of 2024 - early 2025.
Companies interested in this upcoming procurement are requested to provide their contact details no later than 20th of September 2024 by filling in the contact information on the attached form: https://forms.office.com/e/2RT1q32P4U
The intention of The Finnish Medicines Agency Fimea is to arrange company-specific remote meetings with the interested tenderers and also give tenderers an opportunity to comment on the drafts of the tendering material in writing.
Erien kuvaukset
Erä 1: System for receiving and processing marketing authorisation applications
The objective of the system to be procured is to ensure a smooth and consistent user experience for the marketing authorisation specialists and to minimise manual steps. Preliminary needs for the procurement are:
- Receiving and processing marketing authorisation dossiers (marketing authorisation applications and variation applications)
- Validation of the data
- Establishment of the application register
- Exchange of messages
- Management of assessment statements, solutions and decisions
- Management of summaries of product characteristics and package leaflets
- Archiving of marketing authorisation dossiers
- User management
- Work document and task management
- Work planning, resourcing and monitoring
- AI-assisted assessment
- Customer relationship management
- Analytics and reporting
- Business logic
- E-service for marketing authorisation customers
- User interface for marketing authorisation specialists
Erä 2: System related to clinical trials
More information on this will be given later.
Erät
| Erä | Nimi | Ammattiala | Arvioitu arvo | CPV |
|---|---|---|---|---|
| 1 | System for receiving and processing marketing authorisation applications | – | – | 72000000 |
| 2 | System related to clinical trials | – | – | 72000000 |