Two new GDP Non-Compliance Reports from Romania

The National Authority of Medicines and Medical Devices of Romania (NAMMDR) has published two new GDP Non-Compliance Reports in the EudraGMDP database. Both reports concern wholesale distributors in Romania where serious violations of Good Distribution Practice (GDP) were identified.

The first report, dated 7 August 2025 (Report Number: NCD/001/2025/RO), refers to a site in Bucharest. Following an inspection conducted on 30 July 2025, the authority found that the company had violated GDP-relevant provisions of Law No. 95/2006. Among other issues, the authority had not been notified in due time – with 20 days before making an intra-community delivery.

Another entry dated 7 October 2025 (Report Number: NCD/002/2025/RO) concerns a wholesaler in Galati. Here again, an inspection on 1 October 2025 revealed non-compliance with GDP requirements. The identified deficiency was the same as in the first case – failure to notify the NAMMDR in advance of an intra-community delivery.

In both cases, the Wholesale Distribution Authorisation (WDA) was fully suspended.

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.