The GDP Non-Compliance Reports of 2024 - An Overview

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 where the wholesale distributor operates.

The member states shall enter the GMP and GDP certificates which they issue in the 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.

To provide insight into GDP compliance trends, we have analyzed the available data.

Number of Reports

As of 02 January 2025, a total of 46 reports spanning the years 2014 to 2024 have been made available through free and publicly accessible read-only access. However, this number does not reflect the total GDP Non-Compliance Reports, as some have been withdrawn and are no longer displayed.

Overview of the Reports entered in 2024

In 2024, a total of 5 reports were entered into the database. By clicking on the report number, you can access a summary of the respective report.

Report Number Issue Date Country
DE_NW_04_NonCompliance_2023-0023 2024-07-29 Germany
sukls49149/2024 2024-06-27 Czechia
NCD/002/2024/RO 2024-10-16 Romania
NCD/001/2024/RO 2024-10-16 Romania
003-2024-NCD 2024-11-12 Romania

Compared to the previous two years, the total number appears relatively low, with 11 reports posted in both 2023 and 2022. However, in earlier years, only around 4 to 6 reports were published annually.

Type of Deficiencies

The table below provides an overview of the deficiencies that led to the issuance of the five GDP Non-Compliance Reports in 2024. The deviations are quoted verbatim. It is worth noting that these reports often list only the critical and major deficiencies, even though additional deficiencies may have been identified.

Report Number Nature of non-compliance
DE_NW_04_NonCompliance_2023-0023 Insufficient system of qualification of customers and suppliers.
Inadequate verification/due diligence checks of suppliers and the scope of their wholesalers' authorisation before purchase.
Medicinal products were transported on their own responsibility, even though this was prohibited by the national competent authority due to deficiencies in the past.
Non-Compliace regarding adequate documentation.
Non-Compliance regarding outsourced activities.
sukls49149/2024 The company has seriously violated the conditions on which is the permission for actvities linked and fell short of the obligations set out in Section 76 of the Act of Pharmaceuticals by failing to ensure the services of a qualified person.
NCD/002/2024/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).
NCD/001/2024/RO The company failed to comply with GDP legislation regarding all activities performed (e.g. procuring from entities which are not authorized for wholesaling activities, lack of appropriate documentation for reception and delivery, missing documentation of procuring such as invoice for certain products, incorrect reporting of distribution activities at NAMMDR).
003-2024-NCD The responsible person failed to demonstrate knowledge of the provisions in the Good Distribution Practice Guide, as well as other legislative regulations applicable to the distribution of medicinal products for human use. Additionally, the unit show significant deficiencies in the organization and functioning of its quality management system. Furthermore, the unit's IT system was inadequate, unable to effectively support operational activities and meet the traceability and monitoring requirements mandated by current regulations.

Like in previous years, many of the deficiencies documented in the GDP Non-Compliance Reports relate to the Responsible Person. Either the availability of a responsible person was not ensured, or the person did not perform his or her duties to the required extent.

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