May 23, 2022

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Official GAZETTE of the Argentine Republic – Ministry of Health

City of Buenos Aires, 07/04/2022

See File EX-2021-124865806- -APN-DD#MS, Law No. 27350, Regulatory Decree No. 883 of November 11, 2020, Law 26529, Ministry of Health Resolutions No. 800 of November 10, March 2021 and No. 673 of March 24, 2022, and

Taking into account the:

That on March 29, 2022, the decision of this ministry No. 673/2022 was published in the Official Gazette, which amends the second and third annexes of Resolution No. 800/2021 for this same portfolio and includes the fourth appendix.

That in the aforementioned Ministerial Resolution Letter No. 673/2022, the National Program for the Study and Research of the Medical Use of Cannabis and its Derivatives and Non-Traditional Therapies warns of an official error in downloading supplements that are an integral part of it.

Therefore, a new resolution is necessary to sterilize the published Resolution No. 673/2022, while maintaining the technical standards duly agreed upon by all institutional actors that participate in the National Study Program Honorary Advisory Board. Research on the medical use of cannabis, its derivatives, and non-traditional treatments.

In light of the foregoing, the grounds addressed in the above-mentioned regulations are re-emphasized.

This Law No. 27350 regulates medical and scientific research related to the medicinal, therapeutic and/or analgesic use of the cannabis plant and its derivatives.

That in 2020 the Regulatory Decree No. 883/2020 of the aforementioned law was issued, which among its objectives is to create the necessary conditions to ensure that the population has access to the cannabis plant and its derivatives and non-traditional treatments.

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That on March 12, 2021, Resolution No. 800/2021 of the Ministry of Health was published in the Official Gazette in order to regulate the provisions of Article 8 of Decree No. 883/2020 on the Establishment of the Register of Cannabis Programs (REPROCANN), through which access is established, from During controlled cultivation, to the cannabis plant and its derivatives, with appropriate medical indication and support.

This Resolution No. 800/2021 laid the foundations for the operation of Reprocan through its three appendices.

Annex II provides the maximum permissible ranges for controlled autologous cultivation and Annex III provides a template for bilateral informed consent.

That by virtue of the time that has elapsed since the above-mentioned registry was launched, an evaluation of its work has been made for the purpose of its improvement.

The authorities of the National Program for the Study and Research of the Medical Use of Cannabis and its Derivatives and Non-Traditional Therapies participated in the evaluation process, as well as members of the program’s honorary advisory board, especially organizations. Non-governmental civil society representatives.

That within the scope of the Shura Council, and after a transparent and participatory discussion, with logical and well-founded arguments being presented, a proposal to amend Resolution No. 800/2021 was agreed upon, in order to simplify the steps for the better. Ensuring access to treatments for cannabis users for medical, therapeutic and analgesic purposes, as well as compliance with the provisions of Article 8, Paragraph 3 of Regulatory Decree No. 883/2021, regarding the incorporation of civic organizations as third parties authorized to grow to provide a registered patient.

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In view of the foregoing, the National Program for the Study and Research of the Medicinal Use of Cannabis and Its Derivatives and Unconventional Therapies promotes this action.

The National Directorate for Medicines and Health Technology, the United Nations Agency for Medicines and Strategic Information, and the Access to Health Secretariat have assumed their powers.

Likewise, the General Directorate of Legal Affairs has taken over its jurisdiction.

That the Department of Health, as the enforcement authority of Law No. 27350, is empowered to issue supplemental and interpretative regulations and other provisions that may be necessary to improve compliance.

thus,

Minister of Health

decides the following:

Article 1. – Ministerial Resolution No. 673 of March 24, 2022 is repealed.

ARTICLE 2. – Annex II, IF-2021-16395965-APN-DNMYTS#MS, of Resolution 800/2021 of the Department of Health has been replaced by Annex II, ACT-2022-32722908-APN-DNMYTS#MS, which is part of of this action and consent to the “allowable ranges for cultivation” which appear in the above-mentioned appendix.

ARTICLE 3. – Annex III, IF 2021-16396418-APN-DNMYTS#MS, of Resolution No. 800/2021 of the Ministry of Health, has been replaced by Annex III, ACT-2022-32720026-APN-DNMYTS#MS and this is part of this Action and consent to the “Binary Informed Consent” which appears in the above-mentioned appendix.

ARTICLE 4. – Incorporating Annex IV, ACT-2022-32713814-APN-DNMYTS#MS into Resolution No. 800/2021 of the Ministry of Health as an integral part of it. The “NGO Permissible Cultivation Ranges” that appear in the above-mentioned appendix are approved.

Article 5 ° – Communicate, give it to the national address of the official record of its publication and file.

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Carla Visette

Note: The appendix(s) comprising this resolution have been published in the online version of BORA -www.boletinoficial.gob.ar-

And. 04/11/2022 No. 23058/22 Issue. 04/11/2022