Pharmaceutical Affairs Act Article 97

In case a pharmaceutical firm makes use of false information in evidentiary document(s) in applying for registration and market approval, extension of registration, or change of registration in connection with a medicament license it possesses, the said medicament license shall be revoked. In addition, the said pharmaceutical firm shall be suspended from applying for registration and market approval for the said medicament license within a period of two years. Furthermore, if criminal responsibility should be involved, the case shall be referred to the competent judicial authority for investigation.