Invitation to the Danish Medicines Agency's market dialogue on the future platform about a possible future PV system.

26 June 2020

The Danish Medicines Agency, DKMA, wishes to procure a system to aid in pharmacovigilance. At present we collaborate with 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 dialogue with potential vendors about a system, that may eventually replace the functionalities we make use of in our current system.

As an authority, we endeavor to be in the top European level and DKMA wants to procure a pharmacovigilance system (safety database) that matches the current and future needs of our agency. In connection with the acquisition, DKMA wishes to enter into long-term strategic cooperation with the solution provider. The collaboration must support DKMA's ongoing organizational and business goals as well as development in terms of pharmacovigilance and thus benefit both the customer and the supplier.

DKMA seeks a quick transition and to minimize or completely avoid the risks associated with a development project in light of the upcoming deadline for compliance with the E2B(R3) standard. DKMA thus finds that the procurement of an already commercially available solution or product to be more viable than to enter into a comprehensive development project. The notion of the desired solution is, that to a large extent it is already operational preferably used by other agencies and therefore commercially available across Europe.

The Danish Medicines Agency therefore invites all interested suppliers to an open dialogue about a possible future PV system.

Link to consultation letter

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