NAMMDR Publishes GDP Non-Compliance Reports for Romanian Wholesalers

The National Authority of Medicines and Medical Devices of Romania (NAMMDR) has issued two new Good Distribution Practice (GDP) non-compliance reports in the EudraGMDP database, both involving wholesale distributors in Romania.

The first report (7 August 2025, NCD/001/2025/RO) concerns a Bucharest-based site inspected on 30 July 2025. Authorities found violations of GDP provisions under Law No. 95/2006, including failure to notify the NAMMDR 20 days prior to an intra-community delivery.

The second report (7 October 2025, NCD/002/2025/RO) involves a Galati wholesaler inspected on 1 October 2025, which showed the same non-compliance regarding prior notification for intra-community deliveries.

In both instances, the Wholesale Distribution Authorisations (WDAs) were fully suspended.

The reports are accessible via the EudraGMDP database under “Non-Compliance Reports,” filtered by the inspection month and report number.

13-10-2025