Questions and answers

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1. What types of marketing authorisations does the sunset clause concern?

2. How will SUKL apply the sunset clause?

3. How shall be the period of 3 years calculated pursuant to Section 34a (1) and (2) of the Act on Pharmaceuticals?

4. What does a launched medicinal product mean?

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

6. We notified market introduction of the medicinal product before the Act on Pharmaceuticals became effective (31 December 2007). Are we obliged to notify this again?

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?

8. When does the period of 3 years for market introduction of MP commence pursuant to Section 34a (1) of the Act on Pharmaceuticals for generic medicinal products?

9. What does a medicinal product available in the market for the purposes of application of the sunset clause mean?

10. Will a sample be considered for market availability as well?

11. How will the sunset clause be applied if one marketing authorisation number includes several pack sizes of medicinal product?

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?

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?

14. The name of medicinal product has changed. Do periods pursuant to Section 34 (1) and (2) of the Act on Pharmaceuticals commence only after the change?

15. What will be the procedure when sunset clause is applied to transfer of marketing authorisation?

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