MJBizMag September 2020 - 66

AFFAIRS
FOREIGN
ANVISA Authorizations for Individual Patient Imports of Nonregistered Cannabis Products
Source: The Brazilian Health Regulatory Agency (ANVISA)
Copyright 2020 Marijuana Business Daily, a division of Anne Holland Ventures Inc. All rights reserved.
The country has three different
categories of cannabis products:
* Cannabis-based medicines
registered like any other medicine,
for which efficacy and safety needs
to be proved. So far, that includes
only GW Pharmaceuticals' Sativex,
sold under the name Mevatyl
in Brazil.
* Cannabis products with " sanitary
authorization, " the new category
created by ANVISA-the
country's health agency-in
December 2019. These products
do not require proven efficacy via
clinical trials during the first five
years but must obtain pre-market
authorization. As of mid-2020, only
one product was authorized in this
category: a CBD oil.
* Authorizations granted on a
case-by-case basis to import
nonregistered cannabis products,
which also do not require clinical
trials. This has been working since
2014 and is sometimes called
" compassionate use. " During the
first quarter of 2020, almost 3,000
patients received authorization to
import nonregistered products, an
increase of 25% over the previous
quarter. (See chart " ANVISA
Authorizations for Individual
Patient Imports of Nonregistered
Cannabis Products. " )
Local sources estimate that 10,000 to
20,000 patients access cannabis through
the third option. This makes Brazil
unique in Latin America, because no
other country in the region comes close
to that number of patients.
And the growth trend has been
positive. Using data obtained from the
country's health agency, Marijuana
Business Daily previously estimated
Brazil had almost 11,500 patients at the
end of the first quarter of 2020, up from
8,352 at the start the year.
CBD oil makes up most of the
imports because the Federal Council of
66 Marijuana Business Magazine | September 2020
Medicine-the agency responsible
for regulating the medical
profession-restricts the prescription
of cannabis to CBD for treatment of
refractory epilepsy in children and
adolescents.
ANVISA, however, does not limit
imports of nonregistered cannabis
products to CBD, and, in practice, some
doctors also prescribe products with high
THC for conditions other than infant
refractory epilepsy.
But it is harder to get a doctor's
prescription for THC-high products,
and these are also more difficult to ship
internationally.
International Editor Matt Lamers
contributed to this report.
Alfredo Pascual is
Marijuana Business Daily's
international analyst. You
can reach him at
alfredop@mjbizdaily.com.

MJBizMag September 2020

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