Amendments to the functioning of REPROCANN (Resolution 800/2021): Ministry of Health Provision – No. 3132/2024
Healthcare & Life Sciences department report | Amendments to the functioning of REPROCANN (Resolution 800/2021): Ministry of Health Provision – No. 3132/2024
On August 20th of this year, Resolution No. 3132/2024 (the “Resolution 3132/2024”) was published in the Official Gazette by the Ministry of Health (the “Ministry”). This resolution introduced amendments to Resolution No. 800/2021 (the “Resolution 800/2021”), which was issued by the Ministry for the creation and operation of the Cannabis Program Registration System (“REPROCANN”).
Within the framework of Resolution 3132/2024, the Ministry introduced the following changes to the regulations governing the functioning of REPROCANN:
Access to Cannabis through Foundations and/or Civil Associations
Regarding access to Cannabis or its derivatives through civil organizations, Article 4 of Resolution 800/2021 previously only stated that access must be granted through a third party (cultivator) or through a civil organization authorized for these purposes. With the changes introduced by Resolution 3132/2024, the Ministry aims to be much more specific concerning the Civil Associations and/or Foundations that may be registered under REPROCANN, and therefore, grant third parties access to Cannabis.
The highlighted requirements for these entities include:
(i) They must include in their corporate purpose the pursuit of the objectives outlined for the National Program for the Study and Research of the Medicinal Use of the Cannabis Plant.
(ii) They must submit a list of users for whom they are registered as a civil association and/or an authorized cultivator foundation, along with a sworn statement signed by each user to access cultivation through the entity.
(iii) They must provide a record of “solidarity cultivator” registration made by each interested party in their registration with REPROCANN.
Medical Prescription of Cannabis
Previously, the legislation did not distinguish which medical professional could prescribe the use of cannabis and/or its derivatives as a medical treatment for registration under REPROCANN. Resolution 3132/2024 establishes that only those professionals who (i) are registered with the Federal Network of Professional Registries (“REFEPS”) and (ii) have a diploma or master’s degree related to the medicinal use of the Cannabis Plant are authorized to prescribe cannabis use.
Additionally, foundations and/or civil associations intending to register under REPROCANN must demonstrate the effective connection, as representatives of their institution, with the individuals registered under REPROCANN for whom the institution will act as a cultivator.
Extension of the Validity Period of Certificates
Moreover, with the regulatory changes, the validity of the authorization certificate issued by REPROCANN has been extended from 1 to 3 years.
Despite the extension of the period, Resolution 3132/2024 requires Civil Associations and/or Foundations to submit an annual certificate of validity issued by the corresponding registration body, and upon request by the Enforcement Authority, to present documentation proving the achievement of the objectives outlined in their corporate purpose and compliance with the requirements mentioned above regarding the changes to Article 4 of Resolution 800/2021.
Sanctions
In case of non-compliance by Foundations or Civil Associations with (i) the requirements listed in Article 4 of Resolution 3132/2024 or (ii) a court order as described in the previous section, the regulatory changes authorize the Ministry of Health, in its capacity as Enforcement Authority, to revoke the authorizations and/or permits granted under the REPROCANN regime.
Permitted Cultivation Ranges
Unlike Resolution 800/2021, which only allowed indoor cultivation with a limit of 6 square meters, Resolution 3132/2024 maintains these conditions but also introduces the possibility of outdoor cultivation, permitting an area of up to 15 square meters.
Sincerly,