Masterarbeit

Marketing authorisations (MAs) of medicines for human use approved via centralised procedure compared to MAs approved via decentralized, mutual recognition procedure and/or purely national procedures in the EU/EEA - Consideration of the significant influence on maintenance activities/workload and on costs (fees) (examples und survey) ***

Kerstin Leuschke (2022)

Summary
Language: English
According to Directive 2001/83/3, Article 23, and the Notice to Applicants, Volume 2A, Chapter 1, the Marketing Authorisation Holder is responsible for ensuring that the medicinal product to be placed on the market takes technical and scientific progress into account. Therefore, changes may have to be made to the information in the approved dossier to be able to manufacture and test the medicinal product according to generally recognised scientific methods. In addition, continuous monitoring of the benefit-risk ratio must be ensured throughout the entire life cycle of a medicinal product. The establishment of essential internal processes, systems and interfaces at the pharmaceutical company supports the development of strategies and the planning of the necessary procedures for maintaining the approval in the EU/EEA. This thesis primarily considers the differences in the procedural aspects of the individual European procedures such as CPs, MRPs, DCPs and NPs, their influence on upcoming maintenance activities, which result in necessary variations or extensions, as well as the resulting workload for the responsible Regulatory Affairs (RA) manager. In addition, the regulatory costs incurred in the European procedures are compared. The comparison of pharmaceuticals approved by CPs, MRPs, DCPs or purely national procedures showed that primarily significant differences resulted from the use of the different European approval procedures. Furthermore, it became apparent that the processes involved in the practical implementation of each change report must be very closely timed and controlled by the responsible RA manager. It is therefore essential to involve the responsible RA managers in the internal change process as early as possible, as they have the necessary overview and experience with the individual MA and maintenance procedures.
Pages: 76
Annexes: 10, Pages: 103