Masterarbeit

Project Report on: Theory and Reality of Multiple Applications in National Procedure, MRP and CP Demonstrated by Practical Case Reports

Dr. Christian Krezdorn (2002)

Multiple applications are the basis for obtaining more than one marketing authorization for the same medicinal product. Nowadays, nearly every product portfolio of either the global players or the smaller companies has more than one marketing authorization for a medicinal product, especially for the potential blockbusters. These multiple licenses for the same medicinal product play an increasing role for the strategic positioning of pharmaceutical companies, e. g. for Co-marketing at the beginning of a product life cycle or at the end for a so called "early entry" strategy.

This master thesis will provide a better knowledge and understanding of what is called multiple applications by comparison of five case reports of duplicate applications with the current legal system. In addition the benefits of this type of application as well as the pitfalls will be worked out.

Like for submission of an application, discussion starts with planning of submission followed by the process of submission and ends with maintenance of duplicate licenses.

In the planning-status of a duplicate license it turned out that depending on which of the registration procedures is preferred a full application offers more advantages.

With regard to the number of duplicate application, always reasons should be provided to the Commission/RMS for not partitioning the market. Trademarks are very important for the first license but rarely for the duplicate applications because for the latter generic names are normally used.

The most important rule for multiple application is to submit concomitantly with the first license in order to avoid a lot of disadvantages. For subsequent submission an update of expert reports is necessary as well as updated dossiers. Due to submitted variations after obtaining the first MA a "drift" of the SmPC could happen.

With regard to the maintenance, a common renewal date will minimize workload and the PSURS could be better co-ordinated.

One of the major aims of duplicate licenses are Co-marketing activities. With regard to the co-marketing contract, not only financial aspects are important but also drug safety and regulatory affairs aspects. Variations and renewals needs mutual agreement, drug safety needs a co-ordinated reporting.

As for the future of duplicate licenses, the Review 2001 will enforce the centralized procedure and the MRP will be open for generics. Revoking of MA for not being on the market within two years might endanger duplicated licenses. The electronic submission will reduce the amount of paperwork.

As a conclusion, high value of duplicate licenses for the pharmaceutical companies will remain.

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