System for management of marketing authorisation applications of medicinal products and related regulatory submissions

The Finnish Medicines Agency Fimea (later Fimea) is preparing the procurement of a system for receiving and validation, as well as application management, document handling, archiving, and reviewing marketing authorisation applications for medicinal products and related regulatory submissions. Fimea is primarily looking for a software as a service (SaaS) off-the shelf solution that is provided from a public cloud. The system shall enable the necessary integrations with Fimea's other systems, which will be defined later. The aim of the market dialogue is to investigate the offerings of the different service providers; especially whether it is possible to acquire the planned system as a single integrated solution or is it necessary to procure separate modules instead. The procurement includes the following entities: - Marketing authorisation application management system as a software service including possibility to upscale and downscale number of users. - Implementation project, covering the delivery of the system and the deployment of the system and its continuous services, as well as user training. - Continuous services, including e.g. continuous support and maintenance services of the system to the agreed extent, to the extent that they are not included in the software service. - Complementary expert services, covering separately ordered expert work for tasks such as further development of the system, and change management including user training. - Possible options, such as AI capabilities in different functions or modules. Migration of legacy application materials, application history, and other application-related documentation will be part of the procurement. Life cycle data of the medicinal product dossiers (sequences and attributes), application history of the medicinal products, and application related documents, including metadata, must be migrated to the system. The purpose of this request for information is to identify potential tenderers and to gather information on the solutions available on the market. Following the market dialogue, a call for tenders for the procurement will be prepared. For more information about the procurement, please see the Appendix 1 "Additional information about the procurement".