Resolution No. 800/2021: Approval of the Cannabis Program Registration System.
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Healthcare & Life Sciences Department Report | Resolution No. 800/2021: Approval of the Cannabis Program Registration System
Dear Sir or Madam,
On March 10, 2021, the Ministry of Health of Argentina (Ministerio de Salud de la Nación) issued Resolution No. 800/2021, published at the Official Gazette on March 12, 2021 (“Resolution”), by means of which the Cannabis Program Registration System is approved.
The Cannabis Program Registration (“REPROCANN”, by its acronym in Spanish) was created by Decree No. 883/2020 issued last year, which established a new regulation to Law No. 27,350, which sets the regulatory framework for medical and scientific research of the medicinal, therapeutic and/or palliative use of the cannabis plant and derivatives.
In order to obtain the corresponding authorization, all patients who intend to access the cannabis plant and its derivatives through controlled cultivation, as medicinal, therapeutic and/or palliative treatment of pain; from the indication of the medical professional involved and responsible for the treatment, must be registered in said registry.
Users will be able to register in REPROCANN by themselves or through a representative, and obtain authorization to cultivate for themselves, to access the cultivation through a third person (growers) or through a civil organization authorized for that purpose.
Other relevant aspects of the Resolution are:
• Ministerial Resolution No. 1537 of September 21, 2017, issued by the Ministry of Health is repealed.
• Registration in REPROCANN will be done through the link https://reprocann.salud.gob.ar and users who access the cannabis plant and its derivatives, third-party growers, and treating doctors must have a current user in the Argentina.gob.ar platform.
• It is an exclusive requirement to request registration in REPROCANN to have a medical indication for the use of cannabis and its derivatives by a medical professional and to have signed the “Bilateral Informed Consent” which model is attached to the Resolution.
• The ranges allowed to obtain authorization for cultivation are established: (i) between 1 and 9 flowering plants; (ii) up to 6 m2 cultivated; (iii) that it is indoor cultivation; (iv) for transport, between 1 and 6 bottles of 30ml or up to 40 grams of dried flowers are allowed. Outdoor cultivation is not allowed.
The updating of the maximum limits indicated will be in charge of the National Program for the Study and Research of the Medicinal Use of the Cannabis Plant, its Derivatives, and Non-conventional Treatments, for which it will take into account the evolution of scientific evidence.
• The authorization certificate issued by REPROCANN is constituted as reliable and self-sufficient proof of compliance with the conditions established in the Resolution, for a period of one year as from the issuing date.
Should you require any further information on this matter, please do not hesitate to contact us.
Sincerely,
Ana Andrés