The team at CBD.fr has translated the MARIJUANA DAILY BUSINESS article into French for your convenience… you will find the original article written by
Argentina could have its first locally manufactured medical cannabis product as early as 2021. An official document shared by the local pharmaceutical newspaper Pharmabiz shows that Manuel Limeres, head of the Argentine National Administration of Medicines, Food and Medical Devices (ANMAT), has authorized Laboratorio Alef Medical Argentina to register its product, Convupidiol, as a medicine.
The ANMAT authorization is valid for five years.
However, Pharmabiz’s general manager, Cristina Kroll, told Marijuana Business Daily that
“the company still needs to obtain approval for the first production batch” before Convupidiol can be made available to patients. She believes this won’t happen until the end of the first quarter of 2021.
That would be four years after Argentina approved its medical cannabis law in March 2017, a sign that legislative reform doesn’t always translate into immediate, or even short-term, business opportunities.
Kroll said more companies are likely to obtain comparable approvals for other products now that the first one has been granted.
The drug will be manufactured in Argentina and sold in 35-milliliter bottles containing sesame oil, 10% CBD, and vanilla flavoring, according to a Convupidiol document seen by MJBizDaily. It will be used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years and older, similar to FDA-approved Epidiolex. According to the latest edition of MJBizDaily’s Latin American report, only Only a tiny fraction of Argentina’s demand for medical cannabis has been met through legal channels; the supply is primarily commercial, generally through individual imports under a special “compassionate use” access scheme.
The prohibitive costs associated with individual imports force many patients to rely on the illicit market. Furthermore, the Argentine Ministry of Health has restricted eligibility criteria to refractory epilepsy only, significantly limiting commercial opportunities in the South American country.
Also read: Argentina redraws medical cannabis rules, allowing home cultivation
