On August 20, 2024, the Ministry of Health issued Resolution No. 3132/2024 (the “Resolution”), which introduced various amendments to Resolution No. 800/2021 that regulated access to the Cannabis Program Registry (the “REPROCANN” for its Spanish acronym), where all patients who access controlled cannabis cultivation and its derivatives as a medical, therapeutic, and/or pain management treatment must be registered. The main changes introduced by the Resolution are as follows:
- Civil Associations and Non-profit Foundations are now included as entities authorized to be registered with REPROCANN and cultivate Cannabis on behalf of users. To do so, they must: (i) be duly registered as legal entities with the Public Registry according to their jurisdiction; (ii) include in their corporate purpose the pursuit of the objectives set forth in the National Program for the Study and Research of the Medicinal Use of the Cannabis Plant, its derivatives, and unconventional treatments; (iii) submit a list of users for whom they are authorized to cultivate, with clear and precise identification of the individuals registered by REPROCANN; (iv) submit a sworn statement signed by each user previously authorized by REPROCANN to access cultivation through these entities; (v) provide the “solidarity cultivator” registration completed by each of the individuals interested in registering with REPROCANN; and (vi) ensure that members of the Board of Directors of Civil Associations and/or Members of the Board of Foundations have no criminal records.
- Civil Associations and/or Non-profit Foundations registered with REPROCANN may represent a maximum of 150 individuals and will be authorized to cultivate between 1 to 9 flowering plants per person represented, within an area of 6 m² for indoor cultivation and up to 15m² for outdoor cultivation per person represented. Additionally, Civil Associations and/or Non-profit Foundations registered with REPROCANN may transport between 1 to 6 bottles of 30ml, up to 40 dry flowers, or up to the total number of plants authorized per person represented.
- Each third party registered with REPROCANN may represent, in the role of cultivator, a maximum of 2 individuals, including themselves, under the same conditions provided for Civil Associations and/or Non-profit Foundations registered with REPROCANN.
- The medical professional authorized to prescribe the use of Cannabis and/or its derivatives must be registered with the Federal Network of Health Professionals Registries (“REFEPS” for Spanish acronym) and hold a Diploma or Master’s degree in the medicinal use of the Cannabis Plant.
- If the registration application with REPROCANN is submitted by a Civil Association and/or a Non-profit Foundation, they must provide proof of their effective association with a card or certificate issued to demonstrate representation by the institution concerning the individuals registered with REPROCANN for whom they will act as cultivators.
- The validity of the authorization certificate issued by REPROCANN will be three (3) years.
- Civil Associations and/or Foundations registered with REPROCANN must annually submit a certificate of validity and/or an equivalent document issued by the corresponding jurisdictional registration and oversight authority.
- The Ministry of Health, as the Enforcement Authority, may revoke and/or annul, by a reasoned decision, the authorizations and registrations granted under the regime provided by the Resolution.
- Individuals who are (i) registered; (ii) in the process of applying for registration; and/or (iii) authorized by REPROCANN, must comply with the requirements set forth by the Resolution within six (6) months.
