EU GDP Non-Compliance Reports 2025: Key Findings and Trends

Wholesale distributors of medicinal products in the European Union must hold a valid Wholesale Distribution Authorisation (WDA), granted by the national competent authority. GDP inspection outcomes, including cases of non-compliance, are recorded in the EudraGMDP database managed by the European Medicines Agency.

As of early January 2026, 53 GDP non-compliance reports issued between 2014 and 2025 were publicly accessible, although some earlier reports have been withdrawn. In 2025, nine new GDP non-compliance statements were entered, a figure comparable to 2022 and 2023 and higher than the five reports published in 2024.

The reported deficiencies highlight serious breaches of EU GDP requirements. Common findings included data integrity failures, unauthorised access to IT systems, quality decisions made by non-authorised personnel, and supply to unauthorised entities. Several cases involved the absence of a responsible person, inadequate premises or equipment, failures to meet notification obligations, and insufficient cold chain control.

Overall, the 2025 reports underline persistent and significant risks to medicinal product quality, integrity, and patient safety when GDP obligations are not fully respected.

26-01-2026