In today's blog, we are going to talk about health authorization for a cannabis product.
Products derived from Cannabis sativa (a plant popularly known as marijuana), have already had their application determined for various diseases, such as Parkinson, Multiple Sclerosis and Alzheimer.
There are two possible ways to obtain health authorization for a cannabis-derived product:
- For the treatment of your own health: Sanitary authorization that allows individuals or their legal representatives to import the product for a period of two years. The criteria are in RDC No. 335/2020;
- For commercialization: Sanitary authorization that allows the manufacture, import, commercialization, prescription, dispensing, monitoring and inspection for medicinal purposes of products with oral or nasal use. The criteria are in RDC No. 327/2019.
In this blog, we will discuss the criteria for health authorization related to the commercialization of the product (option 2).
The first step is to know some assumptions related to these products:
- The Sanitary Authorization of Cannabis products will have a non-extendable period of 5 (five) years. Within this period, the requesting company must request regularization through the registration of medicines;
- Cannabis products must contain predominantly cannabidiol (CBD) and no more than 0.2% tetrahydrocannabinol (THC). Those with THC content above 0.2% can be sold as long as they are intended for palliative care;
- Only manufacturing companies that have a Certificate of Good Manufacturing Practices (CBPF) for medicines issued by Anvisa or importing companies that comply with the Good Distribution and Storage Practices of medicines can request authorization;
Remembering that when the company wants to have more than one cannabis-derived product, it will have to request the health authorization again and put the concentration of these cannabinoids in the name of the product.
If you are in doubt about how to obtain health authorization for your cannabis product, Stone Okamont will guide you through a fast and assertive process, so that your company saves time and money.
How to obtain health authorization for your cannabis product?
All companies subject to sanitary inspection, which have products that may offer health risks, such as medicines, pesticides, cosmetics, etc., must be regularized at ANVISA.
After the company regularization, it is possible to obtain a health authorization for cannabis products. For this, it is essential to present tests and reports that prove the safety and efficacy of the product, in addition to specific information about the product.
First step: Obtaining the Operating License
This is the company's first regularization step and must be obtained from the VISA (Local Health Surveillance) of your municipality or state.
The Operating License is a documentation that confirms that the establishment has technical and operational conditions to carry out the intended activity.
Second step: Obtaining the Company Operation Authorization
Company Operation Authorization (AFE) is analyzed directly by ANVISA (National Health Surveillance Agency). This process involves the compilation of documents, collection of fees and others. Remembering that this is a step that requires the company to already have the VISA’s Operating License.
After the approval of the AFE, the company can request the health authorization for the cannabis product at ANVISA. Obtaining the AFE means that the company operates in accordance with brazilian legislation and is able to operate nationwide.
Third step: Obtaining health authorization for the cannabis product
The health authorization is a document issued by ANVISA, which authorizes the exercise of the activities defined in RDC No. 327 of 2019, after granting the request of the company that intends to manufacture, import or market the product.
In this final step, information about the product is presented, such as stability studies, technical-scientific rationale on the formulation and route of administration, packaging, labeling, among others.
Therefore, to achieve your goal of obtaining health authorization for cannabis products, you must respect the petition process and file it at ANVISA with all the mandatory documentary information.
Talk to who understands the subject!
Stone Okamont can help you in this process. Get in touch with one of our collaborators and find out how to obtain health authorization for cannabis products.
Request your quote below or call one of our collaborators!
