The Danish Medicines Agency, DKMA, wishes to procure a system to aid in pharmacovigilance. At present we collaborate with the UK Medicines and Health Regulatory Agency (MHRA) and occupy a part of their system, Sentinel, which is due to retire. Given the unclear situation about Brexit, DKMA has seen it fit to pursue a market consultation with potential vendors about a system, that may eventually replace the functionalities we make use of in Sentinel. Be aware that this consultation is specifically regarding a signal management system. The market consultation will precede and inform the tender expected to be announced early next year. For further information, please see the link in section I.3).
Se also out earlier published consultation about the part of the same project that does not concern signal mangement:
https://laegemiddelstyrelsen.dk/da/om/aktiviteter-i-eu-og-i-resten-af-verden/invitation-til-markedsdialog-om-nyt-bivirkningssystem-engelsk/
Pharmacovigilance signal management system and associated IT-services. The system should preferably already be commercially available and require as little customer specific modification as possible.
Estimated data of publication should be considered a rough estimate.