First GDP Non-Compliance Report of 2025: Data Integrity Issues at Hungarian Wholesaler

The Hungarian competent authority, the National Centre for Public Health and Pharmacy, has issued a GDP Non-Compliance Report in the EudraGMDP database. The report, dated 21 January 2025, follows an inspection conducted on 17 January 2025 at a wholesale distributor located in Budapest. This inspection uncovered serious violations of Good Distribution Practice (GDP) requirements.

Key Findings: Data Integrity and Unauthorized Actions

The report mentions two critical observations: data integrity problems and unauthorized personnel performing critical decisions regarding medicinal products.

The authority observed, among others:

• Unauthorized personnel accessed accounts and performed critical quality-related decisions.
• Credentials of Responsible Persons (RPs) were shared with other personnel.
• IT systems failed to regulate access permissions and lacked sufficient monitoring, logging, and user identification.
• Remote access was poorly controlled.

Actions taken

The wholesale distribution license has been partially suspended. During the suspension, only medicines that are considered critical by the Hungarian authority can be put into saleable stock. The report also mentions that the wholesaler may buy, supply, sell, and deliver medicinal products during the suspension period.

Source: EudraGMDP Database (Inspection Date: 17 January 2025; Report Number: NNGYK/07461-2/2025). *

* To find the respective report, please click on "Non-Compliance Reports" in the menu on the left-hand side and select in "From Date / To Date" the month the inspection took place. After clicking on "Search" the results list will be displayed, from which you can choose the report with the number mentioned above.