Jonás Bergstein
Bergstein Abogados, Montevideo
jbergstein@bergsteinlaw.com

Introduction

Uruguay was probably one of the first countries in the world to regulate cannabis production for recreational, medical and industrial use (Law No. 19.172, 20 December 2013 (the ‘Law’). The Law established the legal framework for state-control and regulation of the import, export, planting, growing, harvesting, production, acquisition, storage, marketing, distribution and use of cannabis and its derivatives. The Law also created a regulatory agency called – in Spanish – Instituto Nacional de Regulación y Control del Cannabis (IRCCA), (National Institute of Cannabis Control and Regulations) in charge of implementing regulation and control of the above activities. 

Uruguayan regulations contemplate two separate regulatory regimes: (i) one which governs non-psychoactive cannabis (ie, hemp) for industrial uses (Decree No. 372, 16 December 2014; and (ii) another one which governs psychoactive and non-psychoactive cannabis for medicinal uses (Decree No. 46, 4 de February 2015, as modified by Decree No. 246/021, 28 July 2021).

National legislation also ratifies the promotion of scientific research, which contributes to better knowledge and production of scientific evidence regarding both psychoactive and non-psychoactive cannabis. This includes those actions aimed at protecting, promoting and improving public health through products based on cannabis or cannabinoids.

Cannabis for medical purposes

According to the regulation, the planting, cultivation, harvesting, drying, conditioning, storage, production, manufacturing and marketing of psychoactive and non-psychoactive cannabis is permitted for the production, extraction and manufacture of raw material and finished and semi-finished products, based on cannabis or cannabinoids, for medical use.

In order to clarify the terminology used in the regulation, raw materials correspond to flowers, oils and resins and semi-finished products are products which not comply with pharmaceutical standards or are in process of manufacturing.  

Companies interested in conducting the above activities, must obtain the prior authorisation of both IRCCA and Ministry of Public Health (Ministerio de Salud Publica).

Planting, cropping, harvesting and commercialising cannabis for the purpose of therapeutic products (ie, pharmaceutical and vegetable specialties), requires prior authorisation from IRCCA. Interested companies must apply for a license, providing the following information: i) information about the legal/corporate structure of the applicant, to enable the proper identification of its ultimate beneficial owner and the origin of the funds to be injected in the project, in accordance with the applicable anti-money laundering legislation; ii) scope and terms of the license requested; iii) location and area of the plantation/crop; iv) seeds or plants’ origin; v) varietal characteristics of the crops; vi) TCH and cannabinoids’ content in seeds and plants; vii) estimated production volume; viii) safety proceedings; ix) designation of a technical manager; x) destination of the product and of the harvest residues; and xi)  characteristics of the final product.

If the licensee wants to work on the elaboration and industrialisation of pharmaceutical products or file vegetable specialities, the licensee must obtain a prior authorisation from the Ministry of Public Health. In such cases, the licensee should file/register the company as a manufacturer using cannabis and thereafter register/file the finished product with the Medical Department.

One of the most important modifications introduced by Decree No. 246 of 2021 refers to the exportation of raw material, finished and semi-finished products, based on cannabis or cannabinoids for medical use. This regulation allows the exportation of such items by the Ministry of Public Health, as long as the applicant complies with the following documentation and/or information: i) license issued by IRCCA authorising cultivation, industrialisation and marketing; ii) import authorisation certificate issued by the health authority of the importing country, stating that the import of the cannabis product mentioned therein has been authorised and stating the destination of the product to be imported and its purpose; iii) identification of the variety of psychoactive and non-psychoactive cannabis of every production lot; iv) invoice issued by the exporter; v) description of raw materials to be exported (issued by an authorised laboratory), stating the quality of the product and the contents of THC and cannabinoids; and v) certification issued by the medical department (of the Ministry of Public Health) enabling the company as an exporter.

The authorisation (issued by the Ministry of Public Health) to export cannabis for medical purposes expires 90 days from the date of issuance.

Magisterial formulae (fórmulas magisteriales)

More recently, the Uruguay Parliament approved Law No. 19.847 (20 December 2019), with the objective of protecting, promoting and improving public health through quality-controlled products based on cannabis or cannabinoids. The recently enacted legislation contemplates the possibility of producing so-called ‘magisterial formulae’ based on cannabis. In such cases, patients receive a special prescription (based on cannabis) issued by their respective medical doctors, and the pharmacist (working at a pharmacy authorised by the Ministry of Public Health) would prepare ‘tailor-made’ formulae, according to the specific needs stated in the prescription.

This is aimed at addressing the special needs of certain patients who receive treatment based on cannabis. 

Hub of regional distribution of medicines based on cannabis

Uruguay has a long tradition in the pharmaceutical industry. Companies and human resources are frequently recognised for their experience and knowledge of these areas, positioning the country as a reference for the Southern Cone.

Under this premise, Uruguay approved Decree No. 282/020 (5 October 2020), which governs the regulation and control of logistical operations with therapeutic medical cannabis products in warehouses duly authorised by the Ministry of Public Health.

The above warehouses are allowed to receive imports – previously authorised by the Ministry Public of Health – to be redistributed in the region.

This legal framework gives pharmaceutical companies the potential to cover the needs of Brazilian patients when they receive treatments based on cannabis products.