GDP Non-Compliance Report for Romanian Wholesale Distributor
Register now for ECA's GMP Newsletter
The competent authority of Romania (National Agency for Medicines and Medical Devices of Romania) has entered a new GPD Non-Compliance Report dated 15 April 2021 into the EudraGMDP database.
During an inspection conducted in March 2021, it came out that this company does not comply with the Good Distribution Practice requirements: "The company failed to comply with GDP legislation regarding activities performed (e.g. procuring from entities which are not authorized for wholesaling activities). The company does not ensure the services of responsible person."
As a consequence, the wholesale permission was suspended.
Based on the information gained during the inspection, the company only supplied medicines to Romanian customers. According to the authority, there is no need to recall the medicines distributed by this wholesaler.
Source: EudraGMDP Database (Inspection Date: 4 March 2021; Report Number: NCD/011/RO) *
* 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.
Related GMP News
14.05.2025Stimuli Article Proposes Revision of USP Definition of Controlled Room Temperature (CRT)
13.05.2025Survey on GDP Implementation
13.05.2025New Version of the HPRA GDP Guide Published
13.05.2025GDP in the US: Updates on Implementation of DSCSA
13.05.2025GDP Non-Compliance Report: No Responsible Person, proper Storage and Distribution not ensured
13.05.2025Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 2