The Swedish Medical Products Agency (SMPA), together with the Finnish Medicines Agency (FIMEA) and the Danish Medicines Agency (DKMA) established a horizontal collaboration regarding development.

The Swedish Medical Products Agency (SMPA), together with the Finnish Medicines Agency (FIMEA) and 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 FIMEA and 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, FIMEA and DKMA). The procurement does not include work or services related to the Background system, which are covered by the procurement awarded by SMPA in 2019 (see contract notice 2019/S071-167957).