top of page
  • Regulatory House

Which products cannot be registered?

SÚKL has published several types of products on its website for which it is no longer possible to apply for registration as a medicinal product, as they do not meet the definition under Section 2 of Act No. 378/2007 Coll. on Medicinal Products. The products in question are Iceland lichen (Lichen islandicus), Diosmectite/symethicone, activated charcoal and glycerin (suppositories). There are currently several registered products in the database, but these are older registrations. Before applying for marketing authorisation, it is, therefore, necessary to assess whether your product meets the definition of a medicinal product or can be classified in another product category, e.g. medical devices or dietary supplements.

6 views0 comments

Recent Posts

See All

New general MDCG guideline Medical Device Software (MDSW)

The MDCG 2023-4 provides several examples to help determine whether or not the hardware and the software used with it can be considered medical devices. It does not focus on clinical evaluation or cyb


bottom of page