Ausschreibungen

The Medical Product Agency (MPA) intends to do a purchasing of a system for pharmacovigilance reports. The overall purpose of the Adverse Drug Reaction (ADR) system is to handle the communication of reports concerning adverse drug reactions from human and veterinary medicinal products (ADR reports) between the MPA and the outside world. This includes the capability to import and export ADR reports electronically in accordance with standards of the European Medicines Agency (EMA), to store the data of the ADR reports (ADR data) in a database with the possibility to search for a single or groups of reports and to combine the ADR data with product and substance registers as well as other relevant databases. The required ADR system shall be compatible with the existing electronic environment at the MPA, and therefore shall be able to integrate with existing systems and registers. The ADR system shall support reports concerning both human and veterinary medicinal products.

Pharmacovigilance system.

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