GDP Non-Compliance Report: No WDA without Responsible Person

On 12 July 2022, the competent authority of Germany (Regierungspräsidium Karlsruhe) added a new GDP Non-Compliance Report to the EudraGMDP database. The reason given is the fact that there is no responsible person.

Legal Background (in Germany)

The wholesale distribution of medicinal products requires a Wholesale Distribution Authorisation (WDA). Within the European Union, these authorisations are issued by the national competent authority of the member state in which the wholesale distributor operates.

In Germany, relevant requirements can be found in the German Medicines Act (Arzneimittelgesetz - AMG), among others. According to § 52a (1) of the AMG, wholesale trade in medicinal products requires a license. Pursuant to § 52a (2) No. 3, the applicant must appoint a responsible person who possesses the expertise required to perform the activity.

A similar formulation can be found in the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01). According to chapter 2.2, the wholesale distributor must designate a person as responsible person. The responsible person should fulfil their responsibilities personally and should be continuously contactable.

§ 52a (8) AMG stipulates an obligation to notify changes. According to § 52a (8) sentence 1 AMG, the holder of the license must notify the competent authority in advance of any change in the information provided in the application and of any significant change in the wholesale activity, submitting the supporting documents.

Accordingly, a (planned) change of the responsible person must be reported to the authority in advance, for example if the responsible person has resigned and it is already clear that he or she is leaving the company. Of course, cases are also thinkable in which the responsible person is no longer available from one moment to the next, for example, after a serious accident or in the event of prolonged illness. This case is also regulated by law, namely in § 52a (8) AMG. The second sentence states: In the event of an unforeseen change in the responsible person pursuant to Paragraph 2 No. 3, the notification must be made immediately.

GDP Non-Compliance Report

A wholesaler from Baden-Württemberg apparently did not comply with his duty of notification, as the now published GDP Non-Compliance Report of the Regierungspräsidium Karlsruhe shows.

The company distributes non-pharmacy-restricted medical products. The authority writes in the in report that there was no responsible person for Wholesale Distríbution. This was discovered during an inspection on 07 July 2022. As a consequence, the wholesale permit was suspended.

Source: EudraGMDP Database (Inspection Date: 07 July 2022; Report Number: DE_BW-03_:WDA_2018_0012_2022_07_12) *

* 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.