Safety Data Exchange Agreements (SDEAs)
As the marketing of medicinal products is increasingly carried out through contractual arrangements between different companies regarding distribution, co-marketing, licensing and service provision, it is critical to develop Safety Data Exchange Agreements (SDEAs) to define the responsibilities of each party and to specify the processes for exchange of safety information, including timelines and regulatory reporting responsibilities.
- SDEAs should clearly state who is responsible for the respective PV activities. We offer SDEA templates for different conditions, for example PV responsibilities in the context of shared MRP/DCP procedures, out-licensing, distribution or co-marketing of medicinal products and PV service providers.
- MAHs are requested to monitor compliance of contracted partners with regard to PV tasks and responsibilities defined in contractual agreements. We help you to maintain an overview on existing SDEAs and duties set out in these agreements so that compliance can be controlled. This is especially relevant in view of PV inspections.
- We also prepare the list of SDEAs which has to be maintained in the Pharmacovigilance System Master File (PSMF).