The Swedish Medical Products Agency intends to productize and customize existing IT support for the management of adverse reactions and signals for human medicine and veterinary medicine.
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. 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 Swedish Medical Products Agency intends to productize and customize existing IT support for the management of adverse reactions and signals for human medicine and veterinary medicine.
Invitation
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.
SMPA, acting in its own name and on behalf of 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 and DKMA). DKMA will need an interim solution (DKMA MVP) to go live 30th June 2022. This means that this procurement 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).