Medicines

In order to provide the Brazilian population with safe and quality products based on substances derived from Cannabis, Anvisa published, in December 2019, a rule that provides for procedures for the granting of Sanitary Authorization for the manufacture and import, as well as as it establishes requirements for the commercialization, prescription, dispensing, monitoring and inspection of Cannabis products for medicinal purposes, and makes other arrangements.

There is a growing demand in Brazil today for the regularization and availability on the market of various products obtained from the Cannabis sativa plant, however, there is not enough data to prove the safety, efficacy and quality of most of the products obtained.

Thus, regulatory paths to enable the availability of products are being discussed, based on the data available so far and the experiences of other countries, such as Canada, Germany, United States, Portugal and Israel.

These paths were evaluated to verify which is the most suitable for the Brazilian population and health system, which resulted in the publication of the current standard on Cannabis. As Cannabis products do not fit into any of the categories provided for in Law 6,360 / 1976, a new regulatory category was created, with requirements for authorization, manufacture, import, dispensation, control, among others for Cannabis products being established.

Cannabis products containing plant-derived or phytopharmaceuticals from Cannabis sativa as active ingredients must predominantly contain cannabidiol (CBD) and no more than 0.2% tetrahydrocannabinol (THC).

Cannabis products may contain THC content above 0.2%, as long as they are intended for palliative care exclusively for patients without other therapeutic alternatives and in irreversible or terminal clinical situations.

Regardless of having previously been analyzed abroad, Cannabis products must be subjected to analysis in a laboratory located in the national territory. When outsourced, the analyzes must be conducted in laboratories certified by ANVISA or in laboratories of companies that manufacture drugs with current CBPF.

Considering that the Medicines Market Regulation Chamber - CMED's objectives are the adoption, implementation and coordination of activities related to the economic regulation of the medicine market, it is not part of the CMED's duties to set a price for the Cannabis product, as it is not it is a medicine but an industrialized product intended for medicinal purposes containing as active plant derivatives or phytopharmaceuticals of Cannabis sativa.

Therefore, the commercialization of products does not depend on prior pricing by CMED. Cannabis products cannot bear commercial names, and must be designated by the name of the plant derivative or phytopharmaceutical followed by the name of the responsible company. In order to petition the Sanitary Authorization for Cannabis products, the requesting company must be registered with Anvisa's petitioning system.

The company responsible for submitting the Sanitary Authorization of the Cannabis product to Anvisa must have a Company Operating Authorization (AFE) issued by Anvisa with activity to manufacture or import medicine, Special Authorization (AE), Certificate of Good Manufacturing Practices (CBPF) of medicines for the company that manufactures the product, Good Practices for Distribution and Storage of medicines, Technical and scientific rationale that justifies the formulation of the Cannabis product and the route of administration, Technical documentation of the product quality, Operational conditions to carry out the analysis of the product quality control in Brazilian territory, Ability to receive and handle notifications of adverse effects and technical complaints about the product, Knowledge of the concentration of the main cannabinoids present in the formulation, including CBD and THC, in addition to being able to justify the development of the Cannabis product.

After the company has filed the petition at Anvisa requesting the Sanitary Authorization, there is no legal term defined for publication of the Sanitary Authorization in the DOU after the protocol by the company. However, Anvisa will make the necessary efforts so that all internal procedures take place as fast as possible.

It is important to note that Cannabis products will not be registered but a Health Authorization will be granted.

Each unit sold must be registered with the National System for the Management of Controlled Products (SNGPC), already used for the dispensing of all controlled-use drugs in Brazil.

Cannabis products produced in the national territory must be analyzed in a laboratory of the Brazilian Network of Health Analytical Laboratories (Reblas) and the analytical data obtained must be sent to Anvisa. The Agency will establish and coordinate a special product monitoring program.

The company that holds the Sanitary Authorization must carry out the post-marketing actions of Cannabis products that allow the adoption, when necessary, of measures related to the products under its responsibility.

The holding company must also have a database for the systematic, updated and routine record of activities and information related to notifications of adverse events and quality deviations received.

Annually, the company must prepare a Periodic Benefit-Risk Assessment Report for the Cannabis product. Urgent situations related to the use of these products that affect the user's safety must be reported to Anvisa within 72 (seventy-two) hours after the occurrence.

Radiopharmaceuticals are radiation-emitting substances used in medicine for radiotherapy and for diagnostic imaging exams

All activities related to radiopharmaceuticals must comply with the rules of the National Health Surveillance Agency (Anvisa) and the requirements for radiological protection determined by the National Nuclear Energy Commission (CNEN). Compliance with these standards guarantees the necessary quality and efficacy for the radiopharmaceutical, as well as the protection of the employee who works with this medicine. Most radiopharmaceuticals are administered intravenously and used in Nuclear Medicine for the purpose of diagnosis and / or disease therapy. Its production, distribution and use are considered peculiar compared to conventional medicines, so they follow specific regulations.