MediPharm Labs Enters Brazil – Latin America’s Largest Medical Cannabis Market in Partnership with XLR8 Brazil - Seite 2

“In our view, Brazil is destined to be a global powerhouse in medical cannabis,” said Thiago Callado, Founder and CEO of XLR8. “To make this exciting future a reality, Brazilians need reliable access to formulations that are constructed using proven methodologies that meet the most rigorous international standards of care. By aligning with MediPharm Labs, a company that has GMP certification, the veritable gold seal in pharma-grade production, XLR8 can now begin to fulfill our mission of market leadership.”

About Brazil’s Market
Using a range of pricing, consumption and patient datasets, the LATAM Cannabis Report by Prohibition Partners⁽¹⁾ forecasts that the LATAM market is expected to exceed US$12 billion by 2028, offering “serious growth potential to global cannabis companies.” Today, Brazil is the region’s largest addressable market with a population of nearly 210 million, and according to Prohibition Partners, Brazil could potentially have one of the world’s highest potential patient counts.

In December 2019, Brazil established a new legalized environment for the sale and consumption of cannabis for medical use. As part of the announcement by the National Agency for Health Surveillance of Brazil (“ANVISA”), a new class of medical cannabis products can be prescribed by doctors and sold through pharmacies, enabling safe and legal patient access.

The regulatory framework, valid for an initial three-year term, governs the manufacture and import of medical cannabis products as well as the requirements for commercialization, prescription, dispensing, monitoring and supervision. ANVISA’s rules apply to medicines whose therapeutic indication is restricted to patients with severe and/or life-threatening debilitating diseases and without alternative therapy.

Since 2015, ANVISA has allowed for the importation of cannabidiol-based medicines and other cannabinoids for “compassionate use”.

MediPharm Labs’ facilities were recently certified by the Australian Therapeutic Goods Administration (“TGA”) as meeting the GMP standard of production. The TGA is one of 53-members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Many PIC/S members enter into mutual recognition agreements whereby each participating country’s regulatory authority specifically recognizes certain processes and procedures of the other country to expedite the international flow of goods. For cannabis extracts, Brazil requires PIC/S GMP certification for foreign produced goods and recognizes MediPharm Labs’ TGA GMP certification. XLR8 intends to obtain its ANVISA Sanitary Authorization and approvals required for importation.