7. If we notify an interruption of MP supplies, will the period of 3 years in which a sufficient amount of MP must be available in the market be interrupted as well?
No. Section 34 a (2) of the Act on Pharmaceuticals stipulates that if the medicinal product launched fails to be available in the market in the course of 3 consecutive years, the marketing authorisation shall cease to be valid, and this period shall commence on 1 January of the following year. Obviously, an uninterrupted period of 3 years is meant. Neither the respective clause of Directive 2001/83/EC in Article 24 nor the respective provision of the Act on Pharmaceuticals stipulate that interruption of medicinal product supplies have an impact on the above mentioned. The application of sunset clause thus does not take the interruption of supplies into account.