System for receiving and processing marketing authorisation applications for medical products

The 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 …

CPV: 48311000 Paquetes de software de gestión de documentos, 48610000 Sistemas de bases de datos, 72000000 Servicios TI: consultoría, desarrollo de software, Internet y apoyo, 72260000 Servicios relacionados con el software, 72600000 Servicios de apoyo informático y de consultoría
Lugar de ejecución:
System for receiving and processing marketing authorisation applications for medical products
Organismo adjudicador:
Lääkealan turvallisuus- ja kehittämiskeskus Fimea
Número de premio:
524184

1. Buyer

1.1 Buyer

Official name : Lääkealan turvallisuus- ja kehittämiskeskus Fimea
Legal type of the buyer : Central government authority
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : System for receiving and processing marketing authorisation applications for medical products
Description : The 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.
Internal identifier : 524184

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 72000000 IT services: consulting, software development, Internet and support
Additional classification ( cpv ): 48311000 Document management software package
Additional classification ( cpv ): 48610000 Database systems
Additional classification ( cpv ): 72260000 Software-related services
Additional classification ( cpv ): 72600000 Computer support and consultancy services

2.1.2 Place of performance

Anywhere in the European Economic Area

2.1.4 General information

Additional information : 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.
Legal basis :
Directive 2014/24/EU

3. Part

3.1 Part : PAR-0001

Title : System for receiving and processing marketing authorisation applications
Description : 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
Internal identifier : 1

3.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 72000000 IT services: consulting, software development, Internet and support

3.1.2 Place of performance

Anywhere in the European Economic Area

3.1.5 General information

Reserved participation :
The procurement is covered by the Government Procurement Agreement (GPA) : yes

3.1.6 Procurement documents

3.1.9 Further information, mediation and review

Review organisation : Markkinaoikeus

3.1 Part : PAR-0002

Title : System related to clinical trials
Description : More information on this will be given later.
Internal identifier : 2

3.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 72000000 IT services: consulting, software development, Internet and support

3.1.2 Place of performance

Anywhere in the European Economic Area

3.1.5 General information

Reserved participation :
The procurement is covered by the Government Procurement Agreement (GPA) : yes

3.1.6 Procurement documents

3.1.9 Further information, mediation and review

Review organisation : Markkinaoikeus

8. Organisations

8.1 ORG-0001

Official name : Lääkealan turvallisuus- ja kehittämiskeskus Fimea
Registration number : 0921536-6
Postal address : PL 55
Town : FIMEA
Postcode : 00034
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Contact point : Hansel Oy, Satu Salminen
Telephone : +358 294444227
Internet address : http://www.fimea.fi
Roles of this organisation :
Buyer

8.1 ORG-0002

Official name : Markkinaoikeus
Registration number : 3006157-6
Postal address : Radanrakentajantie 5
Town : Helsinki
Postcode : 00520
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Telephone : +358 295643300
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : Hansel Oy (Hilma)
Registration number : FI09880841
Postal address : Mannerheiminaukio 1a
Town : Helsinki
Postcode : 00100
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Contact point : eSender
Telephone : 029 55 636 30
Roles of this organisation :
TED eSender

11. Notice information

11.1 Notice information

Notice identifier/version : a9c7d610-0a31-4e59-9def-16cef4b5ef00 - 01
Form type : Planning
Notice type : Prior information notice or a periodic indicative notice used only for information
Notice dispatch date : 30/08/2024 06:41 +00:00
Notice dispatch date (eSender) : 30/08/2024 09:56 +00:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00523458-2024
OJ S issue number : 170/2024
Publication date : 02/09/2024
Estimated date of publication of a contract notice within this procedure : 08/01/2025