Masterarbeit

Best way to market for generics (DCP or CP) and the limitations due to a multi-brand marketing strategy

Laura Liekmeier (2014)

Summary
Language: English
This master thesis deals with applications for generic medicinal products in the European Union. It examines generic applications where the reference medicinal product was submitted via centralised procedure (CP). Reference to a centrally authorised reference medicinal product enables the applicant to submit their generic application via CP or via the national route, e.g. via decentralised procedure (DCP) provided that the provisions of Art. 3 (3) Regulation 726/2004 are fulfilled.
The focus of this thesis is set on the comparison of CP and DCP. The thesis aims at investigating which marketing authorisation procedure is preferable. Considerations are based on information about CP and DCP that is available in relevant guidance documents and in public databases.
CP and DCP are compared on the basis of the marketing authorisation procedure duration of practical examples. Moreover the option to submit duplicates, naming conventions as well as application fees are discussed. Differences between CP and DCP that must be taken into account after obtaining a marketing authorization are considered as well.
Attention is paid to companies that expanded through mergers and decided as part of their marketing strategy to keep the company brand as an individual (but not independent) marketing authorisation holder. This is a common practice in the pharmaceutical sector. In Germany, this affects large parts of the generic market. It is investigated how the marketing strategy (a “multi-brand marketing strategy”) impacts the registration strategy for a medicinal product in such cases.
Pages: 44, Annexes: pages : 7