The CBD.fr team has translated the MARIJUANA DAILY BUSINESS article into French for your convenience… you will find the origin of this article written by .
Argentina could have its first locally manufactured medical cannabis product as early as the beginning of 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), authorized the company Laboratorio Alef Medical Argentina to register its product Convupidiol as a medicine.
The ANMAT authorization is valid for five years.
However, Pharmabiz's chief executive, Cristina Kroll, told Marijuana Business Daily that "the company still needs to get approval for the first batch (of production)" for Convipidiol to actually be available to patients.
She believes that this will not happen before the end of the first quarter of 2021.
This would be four years after Argentina approved its medical cannabis law in March 2017, a sign that legislative reform does not always translate into immediate, or even short-term, business opportunities.
Kroll stated that more companies are likely to obtain comparable authorizations 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, like FDA-approved Epidiolex.
According to the latest edition of the MJBizDaily Latin American report, only a tiny fraction of Argentina's demand for medical cannabis has been met legally, with supply coming from commercial products, generally through individual imports under a special "compassionate use" access regime.
The prohibitive costs associated with individual imports force a large number of patients to rely on the illicit market.
Furthermore, the Argentine Ministry of Health has limited eligibility conditions to refractory epilepsy only, significantly limiting business opportunities in the South American country.
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