20 June 2023
In June 2022, two new GPD Non-Compliance Reports were entered into the EudraGMPD Database.
In both cases, it was found during an inspection that the companies concerned did not comply with the GDP requirements referred to in Article 84 of Directive 2001/83/EC. As a consequence, the wholesale authorisations were suspended.
The first GPD Non-Compliance Report, dated 01 June 2022, comes from the competent authority of German (Department of Occupational Health and Safety, Customer Protection and Health). During an inspection at a wholesale distributor from Cottbus, Brandenburg, the following deficiencies were found:
Source: EudraGMDP Database (Inspection Date: 02 May 2022; Report Number: G3-5423/dubrau_roge_20220601) *
On 16 June 2022, the competent authority of France (National Agency For The Safety Of Medicine And Health Products) entered a new GPD Non-Compliance Report. This report refers to an inspection performed at a wholesale distributor located in Tierce.
The authority lists the following deficiencies:
Source: EudraGMDP Database (Inspection Date: 06 January 2022; Report Number: 2022_NCS_001) *
* 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.