UST-20 version 2

Application for an Opinion on a Specific Therapeutic Programme

This guideline is replacing UST-20 version 1, effective date from 19. 12. 2024.

The guideline has been issued based on Section 49, Paragraph 2 of Act No. 378/2007 Coll., On Pharmaceuticals and on Amendments to Some Related Acts (hereinafter “the Act on Pharmaceuticals”) and Section 2, Paragraph 1 of Decree 228/2008 Coll., On Registration of Medicinal Products. The guideline specifies the procedures for submitting a correct and complete application for an Opinion on a Specific Therapeutic Programme (hereinafter “STP”).

The instruction has a recommendatory character.

• UST-20_version2_Application_for_Opinion_on_STP (pdf, 195 kB)