GDP Non-Compliance Report for Romanian Wholesale Distributor

Recommendation

7 September 2022
Bern, Switzerland

GDP in Switzerland (GDP 3)
Specifics in the Distribution of Medicinal Products (Course in english language!)

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.