The GDP Non-Compliance Reports of 2025 - An Overview

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Thursday, 12 March 2026 14.00 - 16.30 h

GDP Update 2026 - Live Webinar

The wholesale distribution of medicinal products requires a Wholesale Distribution Authorisation (WDA). Within the European Union, these authorisations are issued by the national competent authority of the Member State in which the wholesale distributor operates.

The Member States shall enter the GMP and GDP certificates they issue into EudraGMDP. This database is maintained and operated by the European Medicines Agency (EMA). If the outcome of an inspection is that a wholesale distributor does not comply with Good Distribution Practice, a statement of non-compliance may be entered into EudraGMDP.

As in previous years, we have again prepared an overview for 2025 of the published GDP non-compliance reports, including the underlying reasons for each report.

Number of Reports

As of 2 January 2026, a total of 53 reports from the years 2014 to 2025 were made available via free and publicly accessible read-only access. However, this figure does not represent the total number of all GDP non-compliance reports, as some reports have been withdrawn and are no longer displayed.

Overview of the Reports entered in 2025

During the course of 2025, a total of 9 reports were newly entered into the database. By clicking on the respective report number, a summary of the corresponding report can be accessed. With the exception of the first report listed from January, which has since been withdrawn, all documents remain available in EudraGMDP.

Nummer des Berichts	Ausstellungsdatum	Land
NNGYK/07461-2/2025	2025-01-21	Hungary
NCCENTROM/2025/001	2025-03-20	Cyprus
482076-103624037	2025-03-26	Austria
NC/410.0410/2025	2025-04-16	Germany
482952-102672721	2025-05-19	Austria
2024/35203/W13004/00001	2025-06-04	Irland
NCD/001/2025/RO	2025-08-07	Romania
2025_NCS_FR_002	2025-08-21	France
NCD/002/2025/RO	2025-10-07	Romania

The number of reports is therefore broadly in line with the levels observed in 2022 and 2023, during which 11 reports were published in each year. By contrast, only 5 reports were entered in 2024.

Type of Deficiencies

The table below provides an overview of the deficiencies that led to the issuance of new GDP non-compliance reports in 2025. The deficiencies are quoted verbatim. It should be noted that these reports often list only critical and major deficiencies, even though additional deficiencies may have been identified.

Report Number	Nature of non-compliance
NNGYK/07461-2/2025	"During the inspection, two critical observations were found: 1) data integrity problems and 2) unauthorized personnel performing critical decisions according to medicinal products. The following issues were observed: o Data Integrity and Access Control Issues: o Products were put on the saleable stock under the credentials who were not authorized or not present, with evidence suggesting improper access to accounts. o Unauthorized personnel performed quality-related decisions using access credentials of Responsible Persons, violating regulatory requirements. o IT systems do not adequately regulate or monitor access permissions and passwords. Remote access is poorly controlled, with insufficient logging and user identification. o Developer access to live databases is not properly restricted, posing a risk to data integrity. o One of the Responsible Person (RP) transferred full control of the computer, including access credentials to a third party person."
NCCENTROM/2025/001	"SUPPLY TO UNAUTHORISED ENTITIES"
482076-103624037	"SAFFA Pharma e.U. Großhandel International, Inh. Dr. Ing. George A. Saffarnia, does not comply with the Guideline on Good Distribution Practice of medicinal products for human use"
NC/410.0410/2025	"The wholesale distributor can not designate a responsible person. Furthermore, there are no suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products. The NCA was unable to carry out an inspection in accordance with § 64 of the Medicinal Products Act."
482952-102672721	"Currex Pharma GmbH does not comply with the Guideline on Good Distribution Practice of medicinal products for human use"
2024/35203/W13004/00001	"The company did not operate within the guidelines of EU Good Distribution Practice (GDP) in the activities relating to the procurement and supply of a specific product. This resulted in an increased risk of falsified medicines reaching patients. The holder failed to adhere to Chapters 4, 5, 7, and 9 of the EU GDP guidelines. A critical deficiency was identified in an inspection conducted on 24th July 2024, as the wholesaler was not operating within the terms of its Wholesale Distribution Authorisation (WDA). Following the inspection, the products in question were subject to a pharmacy level recall. The reason for the recall was that the products were not supplied in accordance with legal requirements and there was a lack of assurance that the packs had been under adequate cold chain temperature control during their transit to Ireland."
NCD/001/2025/RO	"The company failed to comply with GDP legislation regarding activities performed (from law no. 95/2006, with subsequent amendments and additions, e.g. notify NAMMDR with 20 days before making an intra-community delivery)"
2025_NCS_FR_002	"The responsable pharmacist and the deputy responsable pharmacist of PHARMATREX's pharmaceutical establishment ceased their activities on September 26 and October 03, 2024 respectively, without PHARMATREX having appointed a new responsable pharmacist and informed the French Health Autorities (ANSM) of his appointment, and without PHARMATREX having appointed new deputy responsable pharmacist at the same time."
NCD/002/2025/RO	"The company failed to comply with GDP legislation regarding activities performed (from law no. 95/2006, with subsequent amendments and additions, e.g. notify NAMMDR with 20 days before making an intra-community delivery)"

The GDP non-compliance reports published in 2025 once again reveal serious deviations from the requirements of the EU GDP Guidelines.

These include the unauthorised use of user accounts, inadequately defined access rights, and the performance of quality-relevant decisions by non-authorised personnel, thereby undermining the regulatory requirement for a clear segregation of roles and responsibilities.

In addition, the reports document fundamental breaches of key GDP obligations, including the supply to unauthorised recipients, the absence of or failure to properly perform, the duties of responsible persons, as well as significant organisational and infrastructural deficiencies.

Further findings concerned non-compliance with statutory notification obligations and violations of requirements relating to the cold chain and temperature-controlled transport.