Productization of Pharmacovigilans (PV)

Beskrivning

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.