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Reporting Launch, Suspension, Renewal and Termination of Medicinal Product Placement on the Market with Focus upon Obligations Associated with the Notification of Supply Suspension and Quantities of Goods Available to the MAH

This Guideline is issued with effect as of 01 June 2024.

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, suspension, renewal, and termination 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.

UST-45_Reporting Commencement Suspension Renewal and Termination of Medicinal Product Placement on the Market_final version for the website.pdf, file type pdf, (441,2 kB)

Notification of launch, suspension, renewal or withdrawal from the market of a medicinal product, 29.10.2009

A marketing authorisation holder has a statutory duty to report the placement of a medicinal product onto the market in the Czech Republic and its suspended or terminated and subsequently...