Eesmärk
With this consortium agreement, the Swedish Medical Products Agency (SMPA), the Danish Medicines Agency and the Finnish Medicines Agency establish a long-term collaboration in the area of information technology to fulfil their respective obligations under EU regulation as National Competent Agencies with respect to performance of pharmacovigilance activities. The collaboration is based on Article 12 of Directive 2014/24/EU. As part of the collaboration SPMA shall provide the Background System serving as the basis of the joint development of a joint Pharmacovigilance Solution. This Background system has been procured by SMPA, see contract notice 2019/S071-167957.