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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 a signal management system is not in scope. 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).
Pharmacovigilance 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.