The National Administration of Medicines, Food and Medical Technology (ANMAT) will allow the importation of products containing cannabis derivatives for medicinal use.
Through Resolution 654/2021, published this Thursday, February 18th, in the Official Gazette, the National Ministry of Health approved the Exception Access Regime “to products containing cannabinoids or derivatives of the cannabis plant intended exclusively for medicinal use, either for the treatment of an individual patient or within the context of scientific research.”
The mentioned regime will be applied “when there are no sanitary registrations in the country” of the mentioned products or when they “are in the research phase and exclusively for the pathologies that have evidence of methodological quality” determined by the health portfolio.
The imported products that will be authorized by ANMAT for the treatment of individual patients “must be prescribed by medical professionals registered before the competent health authority, under their exclusive responsibility regarding the quality, safety and efficacy of the indicated product, by means of a prescription in accordance with the regulations in force.” In the first instance, the procedure will be carried out through the “Trámites a Distancia” platform, but said administration will offer alternatives for the patient or his representatives.
The import request for the treatment of individual patients will be carried out in accordance with the provisions of ANMAT in due course. It will be authorized to import the amount of product necessary to cover a treatment of up to 180 consecutive days. The authorization will be sufficient evidence to be submitted to the General Directorate of Customs. “The validity of the form will be 180 days from the date stated in such authorization,” it was specified.
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ANMAT will keep the list of patients who have access to the products, as well as the doctors who prescribe them
In the case of the importation of cannabis derivatives for medical and scientific research, the sponsor must present the authorization of the study in order to request the importation of the quantities authorized in the protocol through the procedures established in the current ANMAT regulations.
For any entry of the indicated product to a patient, “ANMAT may request the updated and available information on the use and commercialization of the product.” It may form working groups for each particular case and summon specialized scientific societies to request an opinion. In addition, it will be able to raise special considerations referred to ethical, clinical and statistical aspects, among others.
Patients who, as of the effective date of this resolution, have had access to a specific product containing cannabinoids or derivatives of the cannabis plant through the import exception regime currently in force, “may continue with the importation of the product in question.”
“Those applications that are in process and are not authorized by the responsible official of ANMAT at the date of the entry into force of this rule, will be evaluated and/or authorized according to the terms provided in this measure,” it was stated.
The portfolio headed by Ginés González García justified the scientific research for the medical use of cannabis, since “the State must facilitate access to those people who do not have health coverage.”
“The existing scientific evidence on the medicinal, therapeutic and/or pain palliative use of the cannabis plant, its derivatives and non-conventional treatments does not have a restrictive character on the doctor’s power to prescribe, however, the intervention of specialized medical professionals is deemed convenient in order to take extreme care of the patient and guarantee the follow-up of the efficacy and safety of the products in question.”
“By virtue of the experience referred by doctors, users and relatives on the symptomatic improvement of patients treated with certain products containing cannabinoids or derivatives of the cannabis plant, different from the product registered in the country and imported through the Exceptional Access Regime, it is necessary to allow the continuity of the treatments already started,” it was remarked in the recitals of the present resolution.
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