30. For how long is the exemption from the application of provision in Section 34a (3) of the Act on Pharmaceuticals granted?
The provision in Section 34a of the Act on Pharmaceuticals does not in any way specify the validity of the exemption. However, Section 34a (6) of the Act on Pharmaceuticals stipulates that “if a medicinal product has not been introduced to the market or has not been available in the market within 6 months after cessation of grounds for granting of an exemption, the respective institute may ex officio decide upon annulment of the decision on granting of exemption”.