Consortium Agreement for a Joint Nordic Pharmacovigilance Solution


15 - Voluntary ex ante transparency notice
Award of a contract without prior publication of a call for competition
7/20/2021 9:28 AM (GMT+02:00)


The Danish Medicines Agency The Danish Medicines Agency
Troels Mogensen
Axel Heides Gade 1
2300 Copenhagen S

Assignment text

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.

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