Cannabis: the rules of the new regulation system.
On March 11th of 2020, RDC 327/2019 comes into force, which instituted the regularization rule for Cannabis, and the first thing we need to know is that ANVISA created a new product regularization figure, which is the Health Authorization (AS) for the manufacture and import of Cannabis products with the purpose of meeting a patient's need, with some exceptions:
· Simplified concession process, where there is no need for prior assessment of the documentation submitted by ANVISA in order to streamline the process but makes it clear that the Agency can do so at any time.
· Sanitary Authorization can be granted based on the Certificate of Good Manufacturing and Distribution Practices protocol until 12/2022.
o Institutes an information leaflet to replace the package insert.
o This is an authorization valid for 5 years.
On the other hand, they impose restrictions on marketing:
· It does not allow a trademark.
· It does not allow “Free Sample”.
· It does not allow any advertising.
The patient or the legal representative must sign a Free and Informed Consent Form (ICF).
The product will be classified as a controlled medicine and must follow the dispensing and bookkeeping rules contained in Ordinance 344.
It also establishes the concentration limit of 0.2% of tetrahydrocannabinol (THC) with Prescription Notification “B” and, above this concentration, and it is only allowed if it is intended for palliative care exclusively for patients without therapeutic alternatives, in irreversible or terminal clinical situations with “A” Revenue Notification.
The company that owns the product must have a monitoring system capable of receiving and handling notifications of adverse events and technical complaints and must prepare the Periodic Benefit-Risk Assessment Report for the product annually.
Although some points have been facilitated and it is not necessary to present complete documentation to ANVISA, RDC 327/19 makes it clear that companies need to have all production documentation, quality control, scientific rationale that supports the use of the product and repeat the quality control in Brazil. The resolution also determines the list of technical documents that must be stored in the company at ANVISA’s disposal.
After the publication of the Sanitary Authorization concession in the DOU, the company will have one year to start marketing.
By December 2022 you must have a Certificate of Good Manufacturing and Distribution Practices (if applicable) approved.
The company must prepare the Periodic Benefit-Risk Assessment Report every year.
An important point to keep attentive, is that the Sanitary Authorization (AS) is valid for 5 years and cannot be extended from the date of publication in the DOU and the company that does not obtain the registration within that period will lose the right to market the product. Therefore, companies will have to prove the safety and effectiveness of their products, and obtain registration following the specific legislation in force in one of the two categories below:
1 - Phytotherapic
2 - Specific as phytopharmaceutical
So much so that Art. 74 explicitly brings this warning: Cannabis products that do not fit the category of drugs within the period stipulated in this Resolution will have the Sanitary Authorization canceled. And it clearly states that companies must follow their research strategies to prove the effectiveness and safety of their formulations.
We draw your attention that this DRC was an alternative to enable the arrival of Cannabis-based products for patients and that it provides the opportunity for interested companies to test the market more quickly, but that the path through the registration route is open for those that have the necessary technical and scientific evidence, and that this path allows the construction of a brand, concept and other marketing prerogatives that a registered medicine is authorized to carry out.