Argentina may need the first locally-manufactured medical cannabis product as quickly as early 2021.
An official document shared by native pharmaceutical newspaper Pharmabiz exhibits that Manuel Limeres, head of Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT), approved the corporate Laboratorio Alef Medical Argentina to register its Convupidiol product as a medicine.
The ANMAT authorization has a validity of 5 years.
However, Pharmabiz General Manager Cristina Kroll instructed Marijuana Business Daily “the company still needs to get the approval of the first (production) batch” to ensure that Convipidiol to develop into successfully accessible to sufferers.
She estimates that won’t occur earlier than the top of the first quarter of 2021.
This could be 4 years after Argentina’s approval of its medical cannabis legislation in March 2017, an indication of how legislative reform doesn’t at all times translate into instant – and even near-term – enterprise alternatives.
Kroll stated extra firms are doubtless to get hold of comparable authorizations for different merchandise now that the first has been granted.
The medicine might be manufactured in Argentina and offered in 35-milliliter bottles, containing sesame oil, 10% CBD and vanilla taste, in accordance to a Convupidiol doc seen by MJBizDaily.
It might be used to deal with seizures related to Lennox-Gastaut syndrome or Dravet syndrome in sufferers 2 and older, like FDA-approved Epidiolex.
According to the most recent version of MJBizDaily‘s Latin American report, solely a tiny fraction of Argentinian demand for medical cannabis has been met with authorized, commercially produced provide, sometimes by way of particular person imports underneath a “compassionate use” special-access scheme.
Prohibitive prices related to particular person imports forces numerous sufferers to depend on the illicit market.
Moreover, the Argentinian Ministry of Health has restricted the qualifying situations to solely refractory epilepsy, drastically limiting enterprise alternatives within the South American nation.