SKP-1 verze 4

Instruction SKP-1 version 4 replaces the previous instruction SKP-1 version 3. Its validity begins on September 21, 2026. This instruction is issued in connection with the provision of Section 54, paragraph 3 of Act No. 378/2007 Coll., on Pharmaceuticals. The Pharmaceuticals Act regulates the field of medicines and related laws. The instruction has a recommendatory character, meaning it is not binding but provides guidance. Annex 1, which concerns the application for an SKP certificate, is also part of the instruction.