Drug database
UST-44 version 1
Published: 13. 6. 2025
Requirements of the State Institute for Drug Control for the creation, content and distribution of a letter to the operator related to a quality defect of medicinal products
This guideline supersedes the guideline UST-44 with effect from 3 February 2025
The Instruction defines the terms, defines the content and regulates the conditions for providing information and documents to the State Institute for Drug Control (hereinafter referred to as “SÚKL”) in the area of creation and distribution of letters addressed to operators concerning information related to quality defects of medicinal products.
Following the Guideline is recommended.