Romanian Authority Issues further GDP Non-Compliance Report

Last month, we reported that the Competent Authority of Romania (National Authority Of Medicines And Medical Devices, NAMMDR) has issued two GDP Non-Compliance Reports in the EudraGMDP database.

Now, another report has been published in mid-November, following an inspection conducted on 16 October 2024, at a wholesale distributor in Craiova, Romania. Based on the information gained during the inspection the company only supplied medicines to Romanian customers.

The authority identified several deficiencies:

• The Responsible Person (RP) failed to demonstrate sufficient knowledge of the Good Distribution Practice (GDP) Guide and other relevant legislative regulations governing the distribution of medicinal products for human use.
• Significant shortcomings were found in the organization and functioning of the company’s quality management system.
• The IT system was inadequate, unable to effectively support operational activities and meet the traceability and monitoring requirements mandated by current regulations.

As a result of these findings, the Wholesale Distribution Authorization (WDA) was suspended.

Source: EudraGMDP Database (Inspection Date: 16 October 2024; Report Number: 003-2024-NCD). *

* 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.