5. When does the period of 3 years for market introduction of medicinal product commence for medicinal products authorized before 31 December 2007?

According to the provision in Section 113 (5) of the Act on Pharmaceuticals, the period of 3 years in which the marketing authorisation holder must launch the medicinal product authorized before 31st December 2007 shall commence on 31st December 2007, i.e. when the Act became effective.

The period of 3 years in which the marketing authorisation holder must launch the medicinal product authorized after 31 December 2007 shall commence on 1st January of the following year after the marketing authorisation has become binding.