DATABÁZE LÉKŮ
UST-45 version 1
Reporting Launch, Interruption, Renewal or Cessation of a Medicine on the Market with Focus upon Obligations Associated with the Notification of Supply Interruption and Quantities of Goods Available to the MAH
This guideline supersedes the guideline UST-45 with effect from July 11, 2025.
The Guideline governing the reporting of supplies of medicinal products on the market has been drafted through collaboration involving the State Institute for Drug Control (hereinafter referred to as “SÚKL” or the “Institute”), the Ministry of Health of the Czech Republic, the Czech Association of Pharmaceutical Companies (ČAFF), and the Association of Innovative Pharmaceutical Industry (AIFP).
The Guideline is issued in an effort to make it easier for the marketing authorisation holder (hereinafter referred to as “MAH(s)”) to set up the processes of reporting the launch, interruption, renewal, and cessation of placement of a medicinal product on the market, with focus upon obligations associated with the notification of supply suspension and the quantity of goods available to the MAH.
The Guideline is of recommendatory nature.