Where deliveries to the Czech Republic are carried out on a monthly basis and in some months they are insufficient, is such a situation subject to notification of SÚKL on suspended deliveries to the market?

Following placement of a medicinal product onto the market, the MA holder is obliged to safeguard the respective medicinal product for the needs of patients in the Czech Republic through its deliveries in adequate quantities and necessary 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 hence obliged to plan and execute deliveries in a manner covering the needs of patients in the Czech Republic. If the deliveries of the respective medicinal product are safeguarded on a monthly basis, and in some months the delivery is insufficient, the situation cannot be classified as suspended delivery. Nevertheless, in some cases, such situation could be considered a breach of Section 33, paragraph 3(g), item 3 of the Act on Pharmaceuticals. In case of a suspension of regular monthly deliveries of the respective medicinal product to the distribution chain, however, in quantities covering patient needs, it concerns suspended deliveries which is subject to notification to SÚKL.