13. If we have a medicinal product whose marketing authorisation number was differentiated or is about to be differentiated, how will the sunset clause be applied to individual differentiated marketing authorisation numbers?
The sunset clause is linked to the marketing authorisation and thus to the marketing authorisation number which is linked to this decision. The period of 3 years when the marketing authorisation holder must introduce the medicinal product to the market shall commence on 1 January of the following year after the date on which the marketing authorisation of medicinal product has become binding, not from the date of differentiation. For medicinal products whose marketing authorisation became binding before 31 December 2007 (see Question 5) Example: MP was authorized in strengths 5, 10 and 20 mg with marketing authorisation number 01/111/11-C. Subsequently, marketing authorisation numbers were differentiated as follows: 5 mg – 01/111/11-A/C 10 mg – 01/111/11-B/C 20 mg – 01/111/11-C/C Only one pack of 5 mg (01/111/11-A/C) was introduced to the market, the period of three years of market availability shall be calculated for all three strengths (5 mg; 10 mg; 20 mg) from 1 January of the following year. In this case, one strength (5 mg) “saves” the remaining two strengths (10 mg; 20 mg).