Is the MA holder obliged to regularly ascertain the current state of stock at distributors´, i.e. availability of the product?
Following the placement of the medicinal product onto the market, the MA holder is obliged to safeguard the concerned medicinal product for the needs of patients in the Czech Republic through its deliveries in adequate quantities and time intervals (Section 33, paragraph 3(g), item 3 of the Act on Pharmaceuticals). With a view to the nature of the product, the method of its use and the anticipated number of patients who will need the product, the MA holder is obliged to plan and execute deliveries in a manner covering the needs of patients in the Czech Republic.