Argentina may have its first locally produced medical cannabis product by early next year.
An official document shared by the Argentinian pharmaceutical newspaper Pharmabiz shows Manuel Limeres, head of Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT), authorized Laboratorio Alef Medical Argentina to register its Convupidiol product as a medicine. According to Pharmabiz General Manager Cristina Kroll, “the company still needs to get the approval of the first [production] batch” before it can become available for patients to purchase.
The new cannabis medicine will be made in Argentina and will contain sesame oil, 10 percent CBD and vanilla flavoring, served in a 35 milliliter bottle. It will be used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients, similar to how the FDA-approved Epidiolex for medical use. The Argentinian Ministry of Health has restricted the qualifying conditions to only refractory epilepsy at this time.
Argentina is also close to allowing industrial hemp in the country after the introduction of a bill aimed at opening the market received support from lawmakers. The country is aiming for a 1.0 percent THC standard limit for hemp products, higher than the global standard of 0.3 percent. The 1.0 percent standard follows the example of other Latin American countries, including Uruguay, Mexico, Ecuador and Colombia.
Argentina legalized medical cannabis in March 2017, although lack of clarity in the law has forced patients to either rely on the illegal market or go without their medicine.
In July, Argentina’s Ministry of Health made changes to the country’s medical cannabis law, allowing cannabis home cultivation and the production of oils and topical medicines by local pharmacies. The change also ensured access to medical cannabis for all patients, free of charge.