By Medlab Clinical Ltd on Monday, 03 December 2018
Category: Pharmaceutical - BioTech

Medlab Clinical expanding cannabis-based medicines into Europe

By having a European subsidiary, Medlab can save on drug registration fees.

In Australia, Medlab has proceeded to stage II for its cannabis cancer trial

() has formally incorporated a wholly owned subsidiary MDC Europe Limited to facilitate expansion into Europe.

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.” 

READ: Medlab Clinical proceeding to stage II for cannabis cancer trial

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.

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