State Institute for Drug Control

An administrative fee for the application pursuant to provision in Section 34 a (3) of the Act on Pharmaceuticals will not be charged. Reimbursement of costs related to the application pursuant to the above mentioned provision is applicable, and according to the Annex 1 of the Decree no. 427/2008 Coll., item R-053, the reimbursement is 5 400,- CZK per application (i.e. for each MA number).

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?

Whole Article Monday, 13. May 2013 | Author

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.

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

Whole Article Monday, 13. May 2013 | Author

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.