Romanian Authority Issues two new GDP Non-Compliance Reports

The Competent Authority of Romania (National Authority Of Medicines And Medical Devices, NAMMDR) has issued two new GDP Non-Compliance Reports in the EudraGMDP database. Both documents are related to human medicinal products and were issued on 16 October 2024.

The first report (Report Number: NCD/001/2024/RO) goes back to an inspection at a wholesale distributor conducted on 14 October 2024. The authority writes: "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)".

The second report (Report Number: NCD/002/2024/RO) refers to an inspection on 10 October 2024. According to the authority, "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)".

In both cases, the findings led to a suspension of the Wholesale Distribution Authorization (WDA).

Source: EudraGMDP Database. *

* 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.