MediPharm Labs Receives Australian Licence to Import Drugs

Published: February 3, 2020

MediPharm Labs Receives Australian Licence to Import Drugs

MediPharm Labs Corp., a global leader in specialized, research-driven cannabis extraction, distillation, purification and cannabinoid isolation, announced the receipt of a key importation licence for its Australian business. This licence is a critical step to building the Company’s international supply chain that will be used to create additional synergies between MediPharm Labs’ Canadian and Australian operations.

The Australian Department of Health, Drug Control Section has issued an import licence to MediPharm Labs Australia Pty. Ltd. (“MediPharm Labs Australia”), a subsidiary of MediPharm Labs, for the importation of drugs listed in Schedule 4 of the Customs (Prohibited Imports) Regulations 1956, which includes cannabis, cannabinoids and cannabis resin. Upon the receipt of the applicable import permits, this licence will allow for the importation of cannabis, cannabinoids and cannabis resin from MediPharm Labs in Canada, and other global authorized exporters, for finalization into tinctures and other product forms in Australia.

“Receiving this licence is an important milestone as we continue to build a multi-jurisdictional GMP-certified pharmaceutical-quality platform to serve the world’s most attractive medical cannabis markets”, said Pat McCutcheon, Chief Executive Officer of MediPharm Labs. “With the initial phases of our Australian facility built-out, we are on track to establishing a global cannabis supply chain leveraging our GMP-certified Canadian facility, technology and access to high quality, fully traceable, cannabis biomass converted to pharma quality concentrates in Canada, to supply MediPharm Labs Australia, its local market, and other permissible global jurisdictions.”

Upon MediPharm Labs Australia receiving its GMP certificate from the Therapeutic Goods Association (“TGA”), the Company will be positioned to leverage a global supply chain to sell cannabis APIs and finished products to countries across the EU, including Germany, due to a Mutual Recognition Agreement between Australia and the EU.

Australia is one of the 49 member countries of Pharmaceutical Inspection Co-operation Scheme (PIC/S), TGA GMP certification could also allow for the easier movement of global product. For example, in Brazil, where new cannabis regulations will be effective April 2020, the Agência Nacional de Vigilância Sanitária (ANVISA) has stated that PIC/s approved cannabis facilities will be permitted to import medical cannabis into the Brazilian market. This recognition will be in effect until 2022 at which time ANVISA will develop their own GMP certification program for international cannabis imports.

Progress in Australia

Australian Facility GMP and Commercialization – Since receiving its State Licences for cannabis substances from the Victorian Department of Health and Human Services, and finishing the initial phases of construction of its 10,000 sq. ft. specialized extraction facility in Wonthaggi in December 2019, MediPharm Labs Australia has completed the first of two stages of a TGA Audit (related to its storage facilities and release for supply) and submitted an evidence package in January 2020. The next TGA Audits of its full production capabilities (including laboratory) are expected in the first half of 2020. This positions the facility to receive Australian GMP certification and full production by H2 2020.

As part of the stepwise build out of its facility, MediPharm Labs Australia recently operationalized its multi-phase supercritical COextraction equipment, installed and started Installation Qualification and Operational Qualification of its vacuum ovens and milling machines, and is in the process of qualifying its softgel capsule filling equipment.

Canadian Facility GMP and Export Readiness – On December 13, 2019, the Company received notification from the Australian TGA that its Canadian manufacturing facility met the requirements for GMP as a Medicines Manufacturer of both Cannabis as a Medicine (oral liquids) and Cannabis as an Active Pharmaceutical Ingredient (“API”). Although this certification specifically applies to the Australian market, it adds to a body of evidence that will assist MediPharm Labs qualifying to supply other medical cannabis markets globally.

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