State Institute for Drug Control

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

For the purposes of sunset clause, the marketing authorisation, and thus the marketing authorisation number listed in the marketing authorisation shall be considered. Individual packs have the same marketing authorisation number. Thus, for the purpose of sunset clause evaluation, all the packs consumed are added. It is important to meet the quantitative requirement, which means one pack per marketing authorisation number regardless of the pack type.