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Elektronikus gyógyszerügy - E-dokumentumok a gyakorlatban Thursday, October 15, 2009
 
Elektronikus beadványokkal kapcsolatos német hatósági tapasztalatok
Thomas Balzer
Bundesinstitut für Arzneimittel und Medizinprodukte

BfArM installed an online application to collect data for national variations. The online application is realised in a portal provided by German PharmNet project. The application enables pharmaceutical companies to enter detailed aspects of nature of variation for an individual medicinal product. It is also possible to submit additional documents related to that variation. The application allows an detailed and interruptible editing process before final submission of the variation. It is also possible to enter variations for medicinal products approved in mutual recognition procedures. Submitted variations with all appended documents were transmitted via an import process to BfArM process management system. For now the submission is restricted to variations of medicinal products. It is planned to extend this application to all types of applications. In August 2009 BfArM started a new project to establish a system for business process management and document management. The combination of these two projects shall improve the agency to handle full electronic processing of applications.