The use of medicinal cannabis in the treatment of various disorders has been steadily increasing. Therefore, specific regulations that are part of a pharmacist's daily routine guarantee the use of the substance.

Although medicinal cannabis-based products cannot be considered traditional herbal medicines, their registration must be based on clinical evidence as recommended by... Anvisa's RDC No. 26/2014, which provides for the registration of herbal medicines.

It is necessary to understand that medicinal plants are plant species used for therapeutic purposes. These plants possess many substances derived from their secondary metabolism that justify their therapeutic use. Some examples of these substances belong to the cannabinoid class. Furthermore, medicinal plants can undergo processes and be transformed into phytotherapeutic products. Thus, phytotherapeutic products are products made from active plant raw materials intended for cure, prophylaxis, or palliative care. However, the concept of phytotherapeutic products differs from phytopharmaceuticals, which are composed of one or more isolated active substances that undergo processes such as purification and structural elucidation..

Following the regulations Anvisa's RDC No. 327/2019Currently, it is already possible to import or even manufacture industrialized products containing plant-derived ingredients or phytopharmaceuticals as active ingredients. Cannabis sativaThese are the so-called cannabis products. Their composition is predominantly cannabidiol (a type of phytocannabinoid commonly represented by the acronym CBD), and tetrahydrocannabinol with no more than 0.2% (a type of phytocannabinoid, represented by the acronym THC), the latter being associated with the effects obtained through recreational use. It is always necessary to respect this proportion of phytocannabinoids, except in cases of palliative care (assistance to patients whose disease no longer responds to curative treatment).

Brazilian Health Regulatory Agency (Anvisa) Resolution RDC 327/2019 establishes important criteria to ensure the safe use of medicinal cannabis:

• In Brazil, the importation of pharmaceutical raw materials is only permitted in the form of plant-derived products, phytopharmaceuticals, in bulk, or as manufactured products. 

• The importation of cannabis spp. plants or plant parts is not permitted;

• It is prohibited to manipulate compounded formulas containing derivatives or phytopharmaceuticals based on cannabis spp.

• Cannabis products cannot have a trade name;

• Only oral and nasal administration methods are authorized;

• Advertising and free samples of products are prohibited;

• If there is a qualitative change in the excipients in the product, according to the IN No. 71/2020The phrase "NEW FORMULA" must be included on the packaging and remain there for at least 1 year.

Registration of products based on medicinal cannabis

Furthermore, to manufacture or import, companies need to have Sanitary Authorization. Anvisa grants the authorization, which is valid for 5 years, upon presentation of the following documents that appear in RDC 327/2019, RDC 318/2019:

Medical Cannabis Dispensing

Regarding the use of cannabis-derived products by individuals, more than a prescription from a legally qualified professional is required. The recent RDC No. 660/2022 Brazilian health regulatory agency Anvisa allows the importation of cannabis-based products directly by the person who will use them, or by their legal guardian or representative. It is also possible for the hospital to which the patient is affiliated to intervene in the importation process if it is previously registered with Anvisa. This measure facilitates the importation process, but there are still a number of requirements necessary for the process to proceed correctly. Only establishments regulated in their respective countries should produce and distribute the product. Similarly, the patient must register with Anvisa through a specific electronic form regarding the importation and use of cannabis-derived products.

Furthermore, the prescription is valid for 6 months and should preferably be in digital format. Therefore, it is important that qualified professionals generate their certified digital signature so that the process is truly simplified.

Control is necessary.

Currently, there are 8 cannabis-based products with active Sanitary Authorization, and it is essential that pharmacists are aware of the regulations regarding medicinal cannabis so that they can dispense it correctly, as required by law. RDC No. 22/2014 According to Anvisa (Brazilian Health Regulatory Agency), which governs the National System for the Management of Controlled Products (SNGPC), at the time of dispensing, the pharmacist must be able to evaluate the prescription and inform the patient about its rational use. Furthermore, in the case of cannabis products, it is important to know that this type of dispensing must be carried out through... Presentation of a Specific Prescription Notification, within the parameters of Decree No. 344/1998It is important to emphasize the need to record the movement of these items in question (in drugstores or pharmacies WITHOUT compounding) through the... National System for the Management of Controlled Products (SNGPC).

The pharmacist's role in relation to medicinal cannabis-based products is regulated by... Resolution No. 680/2020 from the Federal Council of Pharmacy (CFF). This means that thePharmacists need to be familiar with the procedures for granting Sanitary Authorization for the manufacture and import, as well as the requirements for the marketing, prescription, dispensing, monitoring, and inspection of Cannabis products for medicinal purposes.

Regulations governing the use of cannabis are constantly being published and updated. Search for the word "cannabis". in the Legalpharma appand always find the updated standards.

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by Katherine Cervai