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.

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).