Judgement of Federal Administrative Court of Germany on the Required Expertise of the Responsible Person for GDP

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28/29 September 2021

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The Federal Administrative Court (Bundesverwaltungsgericht - BVerwG) is the supreme administrative court in the Federal Republic of Germany. It has its seat in Leipzig. The Court rules on disputes in the area of administrative law, unless another court is competent.

The Court has dealt with the question of what requirements are to be placed on the expertise of the Responsible Person (RP) for GDP. In the recently published judgment, the court has clarified that knowledge of pharmacy comparable to that taught in a pharmaceutical (vocational) training is not required. Rather, the knowledge can also be gained through practical experience.

The headnote of the judgment translated into English is:

The activity of a Responsible Person within the meaning of Section 52a (2) No. 3 AMG [German Medicines Act] requires expert knowledge in the handling of the medicinal products that are the subject of the wholesale authorization. The knowledge can be gained through practical experience, in particular through activities under the guidance and supervision of a Responsible Person in his/her area of responsibility. Pharmaceutical knowledge comparable to that imparted in a pharmaceutical (professional) training is not required.

Please note that the above-mentioned text is not an official translation. The official language of proceedings brought before the Federal Administrative Court of Germany, including its rulings, is German.

For a detailed summary of the judgment in German language, please have a look here ("Urteil des BVerwG: Keine Pharmaziekenntnisse für Tätigkeit als verantwortliche Person für GDP erforderlich").

Source: BVerwG 3 C 7.19, judgment of 05 November 2020 [ECLI:DE:BVerwG:2020:051120U3C7.19.0]