Motagon has been issued by the State Institute for Drug Control (SUKL) a certificate of EU-GMP compliance of a manufacturer for active substances.
The inspection was conducted on 30.08.2022, and the State Agency for Drug Control concluded that “From the knowledge gained during inspection of this manufacturer”, “…it is considered that it complies with The principles of GMP for active substances referred to in Article47 of Directive 2001/83/EC.”
The certificate is issued for manufacturing steps regarding cannabis for medical use, and applies to products containing active substances medical cannabis flower and medical cannabis extracts (oils).
The authenticity of this certificate, as well as updates can be identified through the EudraGMDP website
(http://eudragmdp.ema.europa.eu/).
The freshly-received EU-GMP certificate represents the next logical step in the external validation of Motagon’s sophisticated Quality Management systems, joining the previuosly issued GDP (Good Distribution Practice) certificate and the License for Handling Narcotic Substances.