GDP Non-Compliance Report for Czech Wholesale Distributor

The State Institute for Drug Control in Czechia has published its first GDP Non-Compliance Report for 2024 in the EudraGMDP database. Dated June 27, 2024, the report follows an inspection on May 31, 2024, at Auxilto Healthcare s.r.o. in Prague. The inspection revealed significant GDP violations under Article 84 of Directive 2001/83/EC.

The report states: "The company has seriously breached the conditions related to its operational permission and failed to meet obligations under Section 76 of the Pharmaceuticals Act by not providing the services of a qualified person." It is unclear whether "qualified person" is correctly used, or if "responsible person" was intended.

As a result, the company’s wholesale authorization has been revoked.

Source: EudraGMDP Database (Inspection Date: May 31, 2024; Report Number: sukls49149/2024).