12. A new medication strength was authorized within line extension. The period of 3 years pursuant to Section 34a (1) of the Act on Pharmaceuticals shall commence on 1 January of the following year after the decision on line extension has become binding?

The new strength of medicinal product shall be authorized separately, it has a new individual marketing authorisation number (there is no change or extension of marketing authorisation of the original medicinal product). The period for sunset clause for the original product shall remain unchanged and uninterrupted. However, the period for the new strength shall be calculated in a standard manner, totalling 3 years beginning on 1 January of the following year after its marketing authorisation.