Drug database
UST-15 version 7
Published: 13. 6. 2025
Procedure for health professionals and sellers of reserved medicines in case of suspected quality defect or counterfeit of a medicinal product
This instruction supersedes UST-15 version 6, effective February 1, 2025.
The instruction is issued based on and in accordance with the provisions of Section 23(1)(c) and (d) of Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Some Related Acts (the Act on Pharmaceuticals), as amended.
The guideline is advisory.
Annexes:
Annex 1: Form “Reporting a suspected defect in the quality of a medicinal product”
Annex 2: Form “Reporting a suspected counterfeit medicinal product in the legal distribution chain”