Extraordinary Information n° 68/2019
Informativos . 11/12/19
It was published on this date, the Resolution of the Collegiate Board – RDC No. 327/2019, which establishes the procedures and requirements for granting Sanitary Authorization for manufacturing, marketing, prescription, dispensing, monitoring and supervision of Cannabis products for medicinal purposes.
It defines the category of Cannabis Product: industrialized product, object of Sanitary Authorization by ANVISA, intended for medicinal purposes, containing as active ingredient exclusively plant derivatives from Cannabis sativa.
It states that products with THC (tetrahydrocannabinol) content above 0.2% must be intended for palliative care exclusively for patients with no other therapeutic alternatives and in irreversible or terminal clinical conditions.
The Sanitary Authorization established in this Resolution will be valid for a non-extendable period of 5 (five) years, from the publication in the Official Gazette – DOU. During the period of validity of the Sanitary Authorization, the company responsible for the product must claim its regularization through the drug registration routes, according to specific legislation in force.
Cannabis products cannot have trade names and must be designated by the name of the plant derivatives, and also by the name of the company responsible for the Sanitary Authorization.
The routes of administration of these products should be exclusively oral or nasal.
Cannabis products imported must be regularized in their countries of origin.
Advertising of these products as well as the distribution of “Free Samples” is prohibited.
The company that will apply for Sanitary Authorization of these products must have a Federal Authorization (AFE) for the activity to manufacture or import medicine, as well as a Special Authorization (AE). It must also be certified for Good Manufacturing Practices (GMP) or Drug Distribution and Storage.
The application of the Sanitary Authorization must present technical documentation of product quality, as well as a Free and Informed Consent Form (ICF), to be signed by the patient or responsible, and a plan for monitoring the use of the product.
The quality control of these products should be carried out in the national territory, for all batches, in accordance with the established for specific medicines or herbal medicines, depending on the category of the active substance.
The packaging material should have a horizontal black band covering all sides, at the height of the middle third and not less than one third of the width of the longest side of the largest side.
These products must be dispensed exclusively in drugstores or pharmacies without manipulation, upon presentation of Type “A” or “B” Prescription Notification, depending on the concentration of THC.
Professionals legally qualified to prescribe, other health care professionals and companies responsible for Sanitary Authorization should notify adverse events related to the use of these products.
Cannabis products authorized in accordance with the criteria of this Resolution shall be marketed within 365 (three hundred and sixty-five) days from the publication of the Sanitary Authorization.