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How the Brazilian legal framework may be of interest to national hemp breeding


Registered hemp breeding products with a “sanitary permit” are a new category approved by ANVISA in December 2019 and will come into force in April 2020. These products do not require proven effectiveness through clinical trials during the first five years, but must be registered. 

According to the Brazilian Department of Health, the total number of permits for potential patients to import unregistered cannabis medicines by the end of the third quarter of 2019 exceeded 13,000. These data show growing demand for hemp therapy , despite the current restrictions in the country, which include certain types of imports. Consumers of hemp preparations expect a change in the market situation from April 2020, when new import rules for certain types of products come into force . 

In the third quarter of 2019, 2519 individual import permits were granted , which is 26% more than in the previous quarter, and by 168% compared to the same period in 2018. This trend suggests that the total number of individual permits for the import of unregistered cannabis-based products this year will easily double compared to the previous year, which is partly due to the growing interest in using cannabisa medicines among potential patients, simple philistines and medical workers.

As Brazilian government officials amend existing legislation , individual import of cannabis grows

The program to expand access to drugs based on the therapeutic properties of hemp began to operate in Brazil since 2014, but it gained active interest among consumers precisely in 2019. Until now, the only way to access medical cannabis in the country was to issue a separate permit for the import of relevant products . 

According to a study , based on data from the National Medical Service of the United States and the National Sanitary Surveillance Agency (ANVISA), the maximum possible number of "active" patients at the end of 6807 was the person in September 2019. At the beginning of 2019, there were only about 3,500 “active” patients. “Active” patients consider the number of all new permits (valid for one year) and renewals for existing permits that are issued to patients as admission to the use of hemp therapy and treatment . 

A significant part of the country's imports is CBD oil . The Federal Medical Council (Conselho Federal de Medicina) limits its use for a number of diseases, including the treatment of refractory epilepsy in children and adolescents. It should be noted that the National Agency for Sanitary Inspection does not restrict the import of unregistered hemp products , and often in practice, some doctors also prescribe hemp products as an addition to the main treatment , or supportive therapy using therapeutic cannabis varieties . For some cases of treatment, doctors even prescribe drugs containing a certain amount of THC, which are quite difficult to enter into the country and, accordingly, formalize. In order to facilitate patients' access to hemp production , Brazil has developed new rules for the import, production and distribution of products containing THC and CBD, which were approved in early December 2019 and come into force in April 2020. Meanwhile, the import of hemp will be allowed only in each case.

This means that the country will actually have three different categories of hemp products :

1. Cannabis-based medicines that are registered. Like any other pharmacological drugs, such drugs must undergo a procedure to confirm the effectiveness and safety. So far, there is only Sativex on this list, which is sold in Brazil under the name Mevatyl.

2. Registered hemp breeding products with a “sanitary permit” is a new category approved by ANVISA in December 2019, which will enter into force in April 2020. These products do not require proven effectiveness through clinical trials during the first five years, but must be registered.

3. One-time permits for the import of unregistered hemp products , which also do not require clinical trials. This procedure has been working since 2014 and is sometimes called “compassionate use”.

How will the “sanitary permit” work? Starting in April 2020, companies will be able to apply for a “sanitary permit” to process imports of hemp products , as well as for the production and distribution of similar products. Permissions on production will only be available to companies that import raw materials as well as commercial cultivation of cannabis plants in Brazil are still prohibited. Distribution of hemp products will be possible only through pharmacy chains. At the same time, the import of the “plant or its parts” also remains prohibited. 

Documents required from applicants for sanitary permits include technical documentation, confirmation of the quality characteristics of the product and their stability. Advertising and commercial promotion are prohibited. The sale of products for which “sanitary permits” have been received should begin within one year from the date of receipt of the permit , otherwise the license may be revoked.

Distribution of hemp products can begin only after ANVISA grants permission - one for each product - and this information will be published in the official newspaper of the Brazilian federal government. This means that the first products with a “sanitary permit” are unlikely to be available until mid-2020.

Groups of goods with a “sanitary permit” will allow the use of hemp breeding products in Brazil without clinical trials for five years after the “passing” of a certain procedure . During this period, ANVISA may unilaterally request additional documentation, suspend or even revoke permission to use a particular product . A five year period cannot be extended. Once it is over, the importer company should have registered products for which efficacy and safety must be clinically proven. 

Hemp preparations can be prescribed only after all “other therapeutic agents by Brazilian doctors” have been tested in accordance with the rules and did not bring the desired result. Products with more than 0.2% THC will be available only for palliative care for specific patients who cannot choose a different method of treatment and alleviation of pain syndromes .

A mandatory requirement for all companies that draw up “sanitary permits” is to obtain a GMP certificate for their products . This will seriously limit the number of companies that today want to enter the market and take advantage of new opportunities. The new rules stipulate that until December 2022, the National Agency for Sanitary Inspection will accept GMP certificates issued by medical institutions of countries that are members of the international medical organization PIC / S. After this period, only ANVISA will carry out certification in Brazil. Companies that sell GMP certified hemp medical products in Brazil from another country must obtain an ANVISA certificate if they intend to continue to operate in the market after 2022.

Commentary experts of the Association "Ukrainian industrial hemp"

The change in the “ hemp legislation ” on the Brazilian market once again shows that it is most accessible and safe to promote drugs based on technical varieties of hemp of a therapeutic nature , the requirements for the use and distribution of which are  not more difficult in many countries of the world than for any other crop . Today in Ukraine, the foundation has been laid for the creation and industrial distribution of unique therapeutic cannabis varieties , the level of THC in which does not exceed 0.08% permissible under the law, while the level of useful cannabinoid compounds reaches economically feasible 2 or more percent.

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