Europese Openbare Aanbesteding Informatiemanagementsysteem TSG ten behoeve van Zorginstituut Nederland

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In the TSG, the Zorginstituut, in cooperation with the parties involved, will for each new medicinal product based on a risk assessment look at whether an assessment is required, what type of assessment that must be and who carries it out. This cooperation must be supported by means of an information management system (IMS). By collecting information in one place that the various parties have access to, risk-based working can be carried out and communication about it is supported, as described in the TSG. The information for risk-based working is collected from the Horizon scan and possibly other sources. Initially, the IMS must make the new intake process under the TSG practically feasible; this legislation enters into force on 1 January 2028. In the development phase, the IMS can provide further support for the current situation of the medicinal product assessment process (organisational, process-related, data and functional context), as well as for elements that still need to be worked out. In the TSG, the Zorginstituut, in cooperation with the parties involved, will for each new medicinal product based on a risk assessment look at whether an assessment is required, what type…

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