Eine sachkundige Person nach dem Arzneimittelgesetz anzeigen

As the holder of the authorisation, you bear both the responsibility and the obligation to prove that the relevant Qualified Person is familiar with the product and, in particular, with the procedures for the manufacture and testing of the medicinal product(s).

If you report more than one Qualified Person, you need to clearly delineate the areas of responsibility. In order to assess the demarcation, you must submit the regulations that you, as the permit holder, have laid down in writing or electronically.

In Rhineland-Palatinate, you must submit the documents in the following form:

• Licence to practise medicine / certificate of study (official or notarized copy)
• Proof of practical experience (Signed original; Interim certificates: officially certified copy)
• Curriculum vitae (signed original)
• Certificate of good conduct (original, document type "OB" - sent directly to the authority)
• Declaration of immunity from prosecution (signed original)
• Declaration of commitment (signed original)

If you submit your application via the online service, you must submit the required evidence to the competent authority in the original or as a certified copy.

The processing time depends on the amount of time spent on the examination. If your submitted documents are incomplete or insufficient, the processing time will be extended accordingly.

Unforeseen change of Qualified Person: You must make up for the notification immediately

In Rhineland-Palatinate: State Office for Social Affairs, Youth and Pensions

State Office for Social Affairs, Youth and Pensions