Medlab Clinical set to export first CBD product into the UK market
Health & Biotech
Health & Biotech
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The NanoCBD will be the first of two CBD programs to be launched by Medlab into the UK market.
Australian biotech Medlab Clinical (ASX:MDC) is ready to export its medicinal cannabis program, the NanoCBD, to the UK market.
The company has been granted all the necessary licences, and is now waiting for the final import license from the UK Government.
NanoCBD’s active ingredients contain 16.67 mg/mL cannabidiol (CBD), and less than 0.2% THC.
The drug is administered using Medlab’s proprietary NanoCelle system – a sub-micron spray applied to the oro-buccal membrane, which is the mucous membrane lining the inside of the mouth.
“NanoCBD is our first cannabinoid to enter the UK under an approved compassionate program,” said CEO and founder of Medlab, Dr. Sean Hall.
“Our partners WEP Clinical in the UK have all licenses in place to distribute and supply under the UK Named Patient Program (NPP,) which in a number of ways is similar to the Australian Special Access Scheme (SAS),” he added.
Pricing for NanoCBD is expected to be around GBP 130, and training on how to administer it properly has already commenced two months ago.
NanoCBD was made available under the Australian Special Access Scheme after a new ruling by the TGA (Therapeutic Goods Administration) in September last year.
The TGA ruled that CBD products of 150mg or less are to be down-scheduled from a Schedule 4, to a Schedule 3 classification.
According to TGA definitions, Schedule 3 essentially includes substances which are deemed to be substantially safe in use, but require pharmacist advice and monitoring.
Inclusion into the Special Access Scheme means that health practitioners can access NanoCBD for single patients, despite it not being registered under the Australian Register of Therapeutic Goods (ARTG).
Upon inclusion into the Scheme, Medlab quickly struck an agreement with Arrotex in February to fast track the availability of NanoCBD in Australian pharmacies.
For the UK market, NanoCBD has been manufactured and quality assured for export under an approved compassionate program.
Medlab said that UK prescribers are already seeking approval for use in anticipation of NanoCBD’s arrival.
The NanoCBD program will be the first of two Medlab’s CBD programs to launch in the UK.
The other CBD program to follow is NanaBis, which was rebranded to NanaDol due to naming conventions associated with exporting non-approved pharmaceutical agents from Australia.
The NanaBis or NanaDol program is currently being manufactured with heightened chemistry in order to improve its non-refrigeration shelf life, before seeking export licenses.
This article was developed in collaboration with Medlab Clinical, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.