This guidance document summarizes the legal basics and the BASG requirements with regards to the mock-ups of human and veterinary medicinal products there by providing support for applicants to design mock-ups conforming to the law. The guidance document also describes when and how mock-ups have to be submitted.

• Guide: Mock-ups (L_Z116) - in German only
• Guide: Mock-ups (L_Z116) in change Modus - in German only

Please note that mock-ups submitted outside the cases specified in Section 6.1 of the Mock-up Guidelines will neither be reviewed nor considered approved.

Medicinal products national:  nat@basg.gv.at

Medicinal products AT=CMS:  basg-cms@basg.gv.at

Medicinal products AT=RMS:  rms@basg.gv.at