Ministry of Health of Argentina Resolution No. 654/2021: Exception access regime to products containing cannabinoids or derivatives of the cannabis plant.
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Life Sciences Department Report | Ministry of Health of Argentina Resolution No. 654/2021: Exception access regime to products containing cannabinoids or derivatives of the cannabis plant
Dear Sir or Madam,
On February 12, 2021, the Ministry of Health of Argentina (Ministerio de Salud de la Nación) issued Resolution No. 654/2021 (the “Resolution”), published in the Official Gazette on February 18, 2021, by means of which the Exception Access Regime (the “Regime”) to products containing cannabinoids or derivatives of the cannabis plant (the “Products”) intended exclusively for medicinal use, either for the treatment of a patient or within the context of a scientific investigation is approved.
In line with Decree No. 883/2020 issued last year, which established a new regulation to Law No. 27,350 -which set the regulatory framework for medical and scientific research of the medicinal, therapeutic and/or palliative use of the cannabis plant and derivatives-, the Resolution does not foresee limitations on pathologies to be treated with the Products to be entered by the Regime, unlike Resolution No. 133/2019 -which is rendered ineffective by the Resolution- which only allowed an exceptional access regime of the Products for the treatment of patients with refractory epilepsy.
Also, the recitals of the Resolution make express reference to the first product authorized by ANMAT that will be produced in the country, leaving open the possibility of other registrations in the future.
In this regard, we hereby provide you with this executive summary with the most relevant remarks of the Resolution:
• Resolution 133 dated June 4, 2019, of the former Secretary of Regulation and Health Management (Secretaría de Regulación y Gestión Sanitaria) is repealed.
• The Regime will be applied when there are no health records in the country of products containing cannabinoids or derivatives of the cannabis plant or when said products are in the research phase and exclusively for pathologies that have evidence of methodological quality to allow the continuity of the treatments already started.
• The amount of product necessary to cover the treatment of up to 180 calendar days will be authorized to import.
• The Products must be prescribed by medical professionals registered with the competent health authority, under their sole responsibility for the quality, safety, and efficacy of the indicated product, by means of a prescription adjusted to current regulations.
• The ANMAT will keep a list of the individual patients who access the Products, as well as the doctors who prescribe them.
• For any admission to the country of the indicated product to a patient, ANMAT may request updated and available information on the use and marketing of the product. It may form working groups for each particular case and summon specialized scientific companies in order to request an opinion. In addition, the ANMAT may raise special considerations regarding ethical, clinical, and statistical aspects, among others.
• The Resolution will enter into force upon its publication in the Official Gazette.
Should you require any further information on this matter, please do not hesitate to contact us.
Sincerely,
Ana Andrés