Reporting Supplies of Medicinal Products on the Market (REG-13)
This Guideline is issued with effect as of 05 June 2024.
The Guideline governing the reporting of supplies of medicinal products (hereinafter referred to as “MP(s)”) 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 marketing authorisation holders (hereinafter referred to as “MAH(s)”) to set up REG-13 reporting processes, with focus upon obligations associated with the reporting of volumes of human medicinal product supplies on the market in the Czech Republic.
The Guideline is of recommendatory nature.
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