Masterarbeit

Gibt es eine Zukunft für die Standardzulassung in Deutschland?

Saskia Kissel (2008)

Language: German

In the German regulatory field there is a national feature called standard marketing authorisation. The exemption of the obligation to obtain a marketing authorisation as described in § 36 AMG does not mean, that a medicinal product can enter the German market without valid authorisation. In fact, it is an alternative marketing authorisation procedure, in which the preventive control results from the development of a model for a medicinal product by the competent authority. The pharmaceutical entrepreneur may refer to this model and thus enter the market in an economical and less bureaucratic manner.

In December 2007 the Federal Ministry of Health published a paper called “Eckpunktepapier Standardzulassungen”. It discusses the fact that the German standard marketing authorisation is not in accordance with the directive 2001/83/EC. The paper proposes to authorise the standard marketing authorised medicinal products in a simplified way: as a generic medicinal product according to § 24b AMG, as well established-use according to § 22 (3) AMG or with a registration as traditional herbal medicinal products according to § 39a AMG.

In this thesis an overview is given about the German standard marketing authorisation. Furthermore it discusses if this is in accordance with the directive 2001/83/EC, it presents the proposals of the Federal Ministry of Health and the resulting consequences for the German market. In addition there is an own proposal which can maintain the German feature standard marketing authorisation.

Pages 49, annexes (3): 9