Consortium Agreement for a Joint Nordic Pharmacovigilance Solution

Description

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. Lot 1: The collaboration falls outside the procurement directive as it is a cooperation exclusively between contracting authorities with the aim of ensuring that public services they have to perform are provided with a view to achieving objectives they have in common and the implementation of that cooperation is governed solely by considerations relating to the public interest. Operation, maintenance and development of the joint pharmacovigilence system will be procured by the parties in accordance with article 39 of the public procurement directive. Re: contract value cf. II.1.7) above: as the collaboration is not a procurement, it does not have a specific value. Accordingly, the value is stated as EUR 1. Re: award criteria cf. II.2.5) as the collaboration is not a procurement, it does not have an award criteria. As this form can not be submitted without the field ‘award criteria’ filled in, the field ‘price’ has been been ticked off.