Anyone wishing to engage in wholesale distribution of medicinal products within the meaning of Section 2 para. 1 or para. 2 no. 1 of the German Medicinal Products Act (AMG), test sera or test antigens requires a license. The documents to be submitted are listed in Section 52a para. 2 AMG. The application can be submitted informally.
Trading may not commence before the permit has been issued, which is preceded by an inspection. The violation constitutes a criminal offense.
Once all documents have been submitted, the inspection has been carried out and the deficiencies have been rectified, the permit, consisting of a decision and a certificate, will be issued within three months.
