Questions and answers

16. Will there be a list of pharmaceuticals to which sunset clause could be applied? What information will it contain?

17. Does this mean that SUKL will monitor which medicinal products are jeopardized by the sunset clause and will inform companies?

18. If it for instance occurs that the 3 year period is about to expire shortly, while the medicinal product was not introduced to the Czech market, but there are valid grounds why this did not happen, may an exemption for the MP be applied for?

19. Do I understand it well that the sunset clause shall either apply upon statutory requirements or upon request?

20. Will an administrative fee or reimbursement of costs be charged for the application?

22. Can an exemption be granted due to the fact that the medicinal product is in another administrative procedure (price setting)?

23. Can an exemption be granted on marketing grounds?

24. Can patent protection be considered a relevant reason for granting of an exemption?

25. What would you advise us if the CR is a RMS, the medicinal product does not have any consumption in the Czech market and the only CMS to which we could transfer the respective marketing authorisation does not respond to our e-mails?

26. Who is authorized to represent the marketing authorisation holder in an administrative procedure for granting of exemption from application of the sunset clause?

27. Which marketing authorisation holder does apply for an exemption if there was a transfer of marketing authorisation holder – the old or the new one?

28. Will SUKL publish a list of grounds based on which it will grant an exemption from the sunset clause ex officio?

29. Is there a notification form on your website for launch or resumption of MP supplies to the market after submission of application for granting of exemption pursuant to Section 34a (4) of the Act on Pharmaceuticals? To whom and how should this notifi

30. For how long is the exemption from the application of provision in Section 34a (3) of the Act on Pharmaceuticals granted?