Fernando Martinez Zuviria
Allende & Brea, Buenos Aires
fmartinez@allende.com

Lucrecia Re
Allende & Brea, Buenos Aires
lre@allende.com

Delfina Maria Scagliotti
Allende & Brea, Buenos Aires
dscagliotti@allende.com

Argentine legal framework for medicinal cannabis

Argentina regulates medicinal cannabis through a set of national laws that primarily address the medicinal use of the cannabis plant and the development of a domestic cannabis industry. Law No 27,350 established the National Programme for the Study and Research of the Medicinal Use of the Cannabis Plant, providing the legal basis for the medicinal, therapeutic and palliative use of the cannabis plant and its derivatives.

Decree No 883/2020 regulates the implementation of Law No 27,350 and introduced the Cannabis Programme Registry (REPROCANN), broadening patient access to medicinal cannabis.

Importantly, the legal framework established by Law No 27,350 does not expressly regulate or restrict the technological methods used in the development of medicinal cannabis products. The law provides a broad framework for medical and scientific research on the medicinal use of the cannabis plant and its derivatives, without limiting the production techniques employed, provided that the final purpose is therapeutic and compliant with applicable health regulations.

This approach was further developed by Decree No 883/2020, which expanded the regulatory focus beyond purely experimental research by broadening access to medicinal cannabis, while strengthening the institutional framework for health oversight and for scientific and technological research in collaboration with public institutions, universities and research centers.

In parallel, Law No 27,669 created the Regulatory Agency of the Hemp and Medicinal Cannabis Industry (ARICCAME), responsible for regulating activities related to the cultivation, production, manufacture and commercialisation of cannabis and hemp products. Taken together, these instruments form the core of Argentina’s medicinal cannabis regulatory framework.

This plant-based approach is also reflected in the sanitary regulatory framework. In 2022, the Ministry of Health issued Regulation No 781/2022, which created a specific regulatory category for ‘cannabis-based vegetal products and their derivatives intended for use in human medicine’. These products are distinguished from conventional medicinal products and from herbal medicines.

The regulation is designed for products whose APIs consist of cannabinoids of vegetal origin obtained from the cannabis plant and manufactured in accordance with Good Manufacturing Practices (GMP).

The regime was further operationalised by the National Administration of Drugs, Food, and Medical Technology (ANMAT) Provision No 6431/2022, which approved the sanitary authorisation guidelines applicable to these products and established detailed requirements governing their manufacture, importation, exportation, commercialisation and inspection.

Plant-based assumptions embedded in cannabis regulation

Argentina’s cannabis regulatory framework is largely structured around the cannabis plant and its derivatives.

This plant-centered approach is also reflected in the sanitary regulations governing cannabis-based products intended for human medicinal use, which consistently refer to cannabis-derived vegetal products obtained from the cannabis plant.

As a result, the current regulatory framework is primarily designed for cannabinoid-based products obtained from the cannabis plant, rather than for cannabinoids produced through alternative technological processes.

Biological and biotechnological medicinal products under Argentine law

Parallel to cannabis-specific legislation, Argentina has a regulatory regime for biological and biotechnological medicines regulated by ANMAT.

Biological medicines are defined as products obtained from living organisms or their tissues. This category includes products such as vaccines, blood or blood‑derived products, hormones, antibodies and other complex biological products used for the prevention, treatment or in vivo diagnosis of diseases.

Certain biological medicines are produced using biotechnological methods. Under Argentine regulatory terminology, biotechnological medicines are defined as products whose API is obtained using living organisms or cells through recombinant DNA technology or hybridoma techniques.

The regulatory framework for biological medicines is primarily governed by ANMAT Provision No 7075/2011, which sets out the requirements for the registration of biological medicines. Additional pathways were later introduced through ANMAT Provision No 7729/2011, governing biological medicines demonstrating comparability with a reference product, and more recently through Provision No 1741/2025, which updates the criteria for biosimilarity and comparability. In addition, biotechnological medicines obtained through recombinant DNA technologies are subject to specific requirements under ANMAT Provision No 3397/2012.

Argentina has longstanding regulatory experience with biological and biotechnological medicinal products authorised under ANMAT’s pharmaceutical regulatory framework for biological medicines. Registered biotechnological medicines include recombinant proteins such as human insulin, erythropoietin and growth hormone, as well as colony-stimulating factors and a wide range of monoclonal antibodies used in oncology, autoimmune and inflammatory diseases. In addition, several vaccines authorised in Argentina are produced using modern biotechnological techniques, including recombinant DNA technologies and genetically engineered cell lines.

Biotechnological production of cannabinoids

Recent technological developments have made it possible to produce cannabinoids using engineered microorganisms, such as yeast or bacteria, without cultivating cannabis plants.¹ These processes can yield purified cannabinoid compounds suitable for pharmaceutical use.

From a regulatory perspective, the use of biotechnology as a production tool is not prohibited under Argentine law. What becomes legally relevant is the origin of the active pharmaceutical ingredient and the regulatory category under which the final product is classified.

If biotechnological techniques are used as auxiliary tools within plant-based production processes, for example through plant cell culture or optimisation of plant-derived cannabinoids, the resulting product may still qualify as a cannabis-based vegetal product, provided that the active ingredient is legally considered to be of vegetal origin.

Regulatory classification challenges

From a regulatory perspective, however, these developments challenge the traditional distinction between agricultural products and pharmaceutical active ingredients. Cannabinoids produced through microbial biosynthesis may not easily qualify as cannabis derivatives under the current regulatory framework, as they are not obtained from the cannabis plant.

Prior to the creation of a specific sanitary category for cannabis‑based vegetal products under Ministry of Health Regulation No 781/2022 and ANMAT Provision No 6431/2022, certain cannabidiol‑containing products were authorised under the general medicine’s regulatory framework. In particular, Convupidiol® and an earlier cannabidiol‑based product commercialised under the name Kanbis® were registered as medicine with ANMAT. Following the adoption of Regulation No 781/2022, cannabidiol‑based products, including Kanbis CBD, were subsequently authorised under the new cannabis‑specific sanitary category. This regulatory trajectory illustrates how the same active substance has been subject to different regulatory classifications, depending on the applicable sanitary framework.

A different situation arises when biotechnology is used to produce cannabinoids through non-plant biological systems, such as genetically engineered microorganisms, yeast or other recombinant platforms. In these scenarios, the resulting cannabinoid may no longer fall comfortably within the regulatory category of cannabis-based vegetal products.

Any potential reclassification outside the cannabis-specific framework could imply the application of the general pharmaceutical regulatory regime, which is structurally different from the plant-based cannabis regime and is primarily designed for conventional biological and biotechnological medicines. As a result, developments based on non-plant biotechnological cannabinoid production may face a substantially different regulatory pathway than those relying on plant-derived cannabinoids.

This situation may create a regulatory classification gap. Biotechnologically produced cannabinoids may fall outside the scope of cannabis legislation while not being expressly contemplated under existing pharmaceutical biotechnology rules.

By contrast, other jurisdictions have adopted a different approach. In the United States, the Food and Drug Administration (FDA) regulates cannabinoid-based products under the general drug approval framework and has approved both cannabis-derived and synthetic cannabinoid medicines, without establishing a separate pathway based on plant origin.²

A similar logic applies in the European Union. The European Medicines Agency (EMA) has clarified that there is no specific regulatory framework for cannabis-derived medicinal products, which must comply with EU pharmaceutical legislation and obtain a marketing authorisation regardless of the origin of the active substance. Depending on their composition, some products may qualify as herbal medicinal products, while remaining subject to the general medicines framework, alongside any applicable national requirements.³ To date, neither the FDA nor the EMA has approved medicinal cannabinoid products whose active ingredients are produced through non‑plant biotechnological platforms.

If classified as biotechnological medicinal products, these cannabinoids would likely fall under ANMAT’s regulatory authority and be subject to the requirements applicable to biological medicines. However, this interpretation could raise questions regarding the relationship between ANMAT’s pharmaceutical oversight and ARICCAME’s competence over cannabis-related activities.

As biotechnological production methods continue to evolve, providing greater regulatory clarity will be essential to ensure that Argentina’s legal framework can accommodate emerging cannabinoid technologies while maintaining consistency with existing public health and industry policies.

The emergence of biotechnological production methods may therefore challenge not only national regulations but also the coherence of provincial frameworks. Although biotechnologically produced cannabinoids are not currently addressed under Argentine law, the country’s existing regulatory experience with biological and biotechnological medicinal products provides a potential basis for future regulatory responses. Ensuring regulatory clarity will be essential to accommodate emerging cannabinoid technologies while maintaining patient safety and legal certainty.

Conclusion

Argentina has made significant progress in regulating medicinal cannabis, establishing a legal framework that supports scientific research, patient access and the development of a domestic cannabis industry. This framework, however, remains firmly anchored in the concept of plant-based production.

As biotechnology continues to transform pharmaceutical manufacturing, cannabinoids produced through engineered biological systems challenge the assumptions underlying existing cannabis regulation. Although such products are not currently contemplated under Argentine law, their potential emergence highlights a regulatory gap between cannabis-specific legislation and the pharmaceutical framework governing biological and biotechnological medicines.

Addressing this issue proactively would allow Argentina to adapt its regulatory system to emerging cannabinoid technologies while preserving the public health and regulatory objectives that underpin its cannabis and pharmaceutical policies.

Notes

1     See, eg, Luo, X et al, ‘Complete biosynthesis of cannabinoids and their unnatural analogues in yeast’, Nature (2019), available at: https://doi.org/10.1038/s41586-019-0978-9; and González-Fernández et al., Biotechnological production of cannabinoids, Biotechnology Advances (2022), https://doi.org/10.1016/j.biotechadv.2022.108151.

2     U.S. Food and Drug Administration, ‘FDA and Cannabis: Research and Drug Approval Process’, available at: www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process.

3     European Medicines Agency (EMA), Questions and Answers regarding Cannabis derived medicinal products and the scope of EU herbal monographs for herbal medicinal products within the EU medicines legislation, EMA/HMPC/176770/2022 (2023), available at: www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-regarding-cannabis-derived-medicinal-products-and-scope-eu-herbal-monographs-herbal-medicinal-products-within-eu-medicines-legislation_en.pdf.