The subsidiary will be used specifically for current and future dealings regarding NanaBis™ and the proposed drug registration models as per the European Medicines Agency (EMA).
NanaBis™ is one of two of Medlab’s cannabis-based medicines which contains formulations of tetrahydrocannabinol (THC) and cannabidiol (CBD).
European registration of NanaBis™ progressing
Meetings have been held with EMA on the pathway for registration of NanaBis™.
Conditional approval is likely. Registration with a significant fee reduction requires the company to be domiciled in Europe.
Medlab’s CEO Dr Sean Hall said: “MDC as a Group is strategically placed to progress commerce in Europe through potential trade deals, especially in conjunction with the recently announced granting of an export licence for NanaBis™.
“This move is also very exciting as it provides NanaBis™ an introduction into Europe as a potentially future compliant drug.”
In late October 2018, Medlab successfully completed stage I of the NanaBis™ human trial on cancer patients at Royal North Shore Hospital.
The trial is progressing as planned and currently in stage II of the Ethics approved trial.
This NanaBis™ program will serve as an integral part of both domestic and foreign regulatory approvals.