4/5 October 2023
On 16 August 2022, the National Agency for Medicines and Medical Devices of Romania added a new GDP Non-Compliance Report to the EudraGMDP database. The company in question "failed to comply with GDP legislation regarding activities performed (e.g. procuring from entities which are not authorized for wholesaling activities)".
According to the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01), "Procuring" is defined as follows: "Obtaining, acquiring, purchasing or buying medicinal products from manufacturers, importers or other wholesale distributors."
Chapter 5.2 (qualification of suppliers) states that "wholesale distributors must obtain their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation, or who are in possession of a manufacturing authorisation which covers the product in question. [...] Where medicinal products are obtained from another wholesale distributor, the receiving wholesale distributor, must verify that the supplier complies with the principles and guidelines of good distribution practices and that they hold an authorisation for example by using the Union database. [...]"
The Non-Compliance Report goes back to an inspection conducted in June 2022 at a wholesale distributor in Bacau. It was found that it does not comply with the GDP requirements. As a consequence, the wholesale permit was suspended. The authority points out that "based on the information gained during the latest inspection the company only supplied medicines to Romanian customers."
Source: EudraGMDP Database (Inspection Date: 08 June 2022; Report Number: NCD/012/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.