Application for an Opinion on a Specific Therapeutic Programme
This guideline is replacing UST-20 version 0, effective date from 1. 11. 2020.
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.