Industria Legal – The Cannabis and Hemp Industry Generates Expectations in Ecuador


DATE: 02-07-2021


Felipe Samaniego

December 2019 was a month of legal changes in Ecuador. First, the Organic Law Reforming the Comprehensive Organic Criminal Code was published. Still, it was not until June 2020 that it came into force, reforming the Organic Law for the Comprehensive Prevention of the Socioeconomic Phenomenon of Drugs and the Regulation and Control of the Use of Listed Substances Subject to Control. The magazine Industria Legal dedicates a page to the information offered about this matter by our expert partner in Regulatory Law, Felipe Samaniego since this reform gave way to Ecuador’s new cannabis and hemp industry.

The exclusion of substances subject to control to cannabis and hemp with less than 1% THC in dry weight and a term of 120 days for the Ministry of Agriculture and Livestock to issue the corresponding regulation are among the new reforms.

Not only that, but also, through this agreement, new guidelines are established applicable to the regime of seven licenses, different for each activity allowed in the non-psychoactive cannabis industry, hemp and hemp for industrial use, “from the import and production of seeds to the production and export of derivatives, biomass and/or flowers,” according to Samaniego.

Our expert ends his article stating that “the rapid development of the regulatory framework that regulates the activities of agroindustrial activities, by the Ministry of Agriculture and Livestock, caused that both the Ministry of Health and the National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) as well as the Agency for the Regulation and Control of Phytosanitary and Zoosanitary (AGROCALIDAD) issue the normative bodies that regulate finished products destined for human and veterinary use and consumption that have derivatives of non-psychoactive cannabis or hemp in their composition ”.

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PharmaBoardroom – Emerging cannabis and hemp industry in Ecuador

PharmaBoardroom - Emerging cannabis and hemp industry in Ecuador - CorralRosales - Lawyers Ecuador


DATE: 28-06-2021


Felipe Samaniego

With the Criminal Law Reform enacted a year ago, the cannabis and industrial hemp industry has become an emerging industry in Ecuador. Our partner Felipe Samaniego writes about it for Pharma Boardroom.

Samaniego begins the article by writing about what’s new since the reforms now include decriminalizing the possession of drugs that contain cannabis or derivatives as an active ingredient for therapeutic, palliative, medicinal use, or alternative medicine.

The Law for Drug Use, Prevention, and Control is also modified with the change, which now excludes the control of non-psychoactive cannabis or hemp.

On October 19, 2020, the Ministry of Agriculture issued Ministerial Agreement No. 109-2020, which regulates the Import, Sowing, Cultivation, Harvest, Post-harvest, Storage, Transportation, Processing, Marketing, and Export of non-psychoactive cannabis or hemp and hemp for industrial use.

Samaniego adds that “this regulation establishes the requirements that must be met to obtain the seven types of licenses, which authorize the following activities only concerning cannabis or hemp with a THC concentration of less than 1%:

  1. License for Import and Marketing of Non-Psychoactive Cannabis or Hemp Seeds or Cuttings, or Hemp Seeds for Industrial Use.
  2. License for the Import and Commercialization of Non-Psychoactive Cannabis or Hemp Seeds, or Non-Psychoactive Cannabis or Hemp Cuttings or Hemp Seeds for Industrial Use.
  3. License for the cultivation of cannabis or non-psychoactive hemp.
  4. License to grow hemp for industrial use.
  5. License for the processing of non-psychoactive cannabis or hemp and production of non-psychoactive cannabis or hemp derivatives.
  6. License for Banks and Research of Plant Improvement and/or Germplasm.
  7. License for the Acquisition of Non-Psychoactive Cannabis or Hemp Derivatives and/or Biomass or Flowers, or Hemp Biomass for Industrial Use for Export.

As soon as this came into effect, the Ministry of Health and the Agency for Health Regulation, Control, and Surveillance had to develop regulations applicable to finished products. This happened because the Criminal Law “also opened the door to producing and importing finished products,” according to our partner.

Samaniego also adds that at the end of February of this year 2020, “the Health Regulation, Control, and Surveillance Agency issued a resolution with the ‘Sanitary Technical Regulations for the regulation and control of products for human use and consumption that contain cannabis non-psychoactive or hemp, or its derivatives.” This resolution makes it possible to legally produce, import, and commercialize the following finished products with the THC concentration specified in each category:

  • Less than 1% THC: general, natural pharmaceutical products processed for medicinal use and homeopathic. Also cosmetic products and medical devices; hygienic products for industrial use; pesticides for domestic use, for public health or for industrial use; household hygiene products and absorbents for personal hygiene.
  • Less than 0.3% THC: processed foods and food supplements.

On February 26, Ministerial Agreement No. 148-2021 was also issued after a meeting of experts developed regulations for the prescription, provision, and therapeutic use of medicinal cannabis and pharmaceutical products containing cannabinoids.

Samaniego concludes by pointing out that “the regulatory framework for cannabis / hemp has moved relatively quickly in Ecuador and has opened the eyes of many local and international investors. The authorities are aware of what this industry can generate for the country regarding research and investment. Ecuador is the only country in the region that has shown such openness; the players will be able to develop a myriad of producs as long as they abide by all the rules. As a result, this area is expected to become a research and development group for cannabis and hemp products to be sold worldwide.”

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The regulation that controls the agroindustrial chain of psychoactive cannabis or hemp and hemp for industrial comes into effect


October 19th, 2020, the Ministry of Agriculture issued the Ministerial Agreement No.109-2020, which regulates the  IMPORT, PLANTING, GROWING, HARVEST, POST HARVEST, STORAGE, TRANSPORTATION, PROCESSING, MARKETING AND EXPORT OF NON PSYCHOACTIVE CANNABIS OR HEMP AND HEMP FOR INDUSTRIAL USE. This Ministerial Agreement entered into force upon its signing.

Among the provisions included in this Ministerial Agreement, article 22 establishes the Licenses that have to be obtained by those who wish to engage in the following activities:

• Import and Commercialization of Non-Psychoactive Cannabis or Hemp Seeds, or Non-Psychoactive Cannabis or Hemp Cuttings, or Hemp Seeds for Industrial Use. (LICENSE 1)

• Growing and Production of Non-Psychoactive Cannabis or Hemp Seeds, or Non-Psychoactive Cannabis or Hemp Cuttings, or Hemp Seeds for Industrial Use. (LICENSE 2)

• Cultivation of Non-Psychoactive Cannabis or Hemp. (LICENSE 3)

• Cultivation of Hemp for Industrial Use.

• Non-Psychoactive Cannabis or Hemp Processing and Non-Psychoactive Cannabis or Hemp Derivatives production. (LICENSE 5)

• Plant breeding and / or Germplasm and Research Banks. (LICENSE 6)

• Acquisition of Derivatives and / or Biomass or Non-Psychoactive Cannabis flower or Hemp, or Hemp Biomass for Industrial Use, for Export. (LICENSE 7)

Who can obtain these licenses: entities, cooperatives, associations or communes, universities legally constituted and / or domiciled in Ecuador, which may develop one or more activities provided for in the Regulation.

The minimum extension of land, depending on the type of crop which may be cultivated gradually according to the Agricultural Production Plan approved by the National Agrarian Authority, is the following:

• Hemp for Industrial Use – 5 hectares.
• Non-Psychoactive Cannabis or Hemp – 5 hectares in the open field and 2 hectares in greenhouse.

The period in which the above-detailed minimums must be met may not exceed 5 years from the first crop.

License for the Planting and Production of Non-Psychoactive Cannabis or Hemp Seeds, or of Non-Psychoactive Cannabis or Hemp Cuttings, or of Hemp Seeds for Industrial Use – minimum extension 0.5 hectares.

Licenses for Plant Breeding and / or Germplasm and Research Banks will not be subject to a minimum surface area.

The Ministerial Agreement establishes general and specific requirements for each type of license.

The general requirements are:

a. Application form for Licenses of Non-Psychoactive Cannabis or Hemp, or Hemp for Industrial Use.

b. Copy of the Taxpayer Registry (RUC), which must include the activity or activities to be carried out by the Applicant, information that will be verified on the website of the competent authority.

c. Copy of the statutes of the entity, public entity, cooperative, association or commune, legally constituted, whose objective includes the activities to be carried out by the Applicant.

d. Notarized copy of the appointments of the legal representatives.

e. Affidavit issued by the legal representative of the applicant, granted before a public notary, with the detail of the activities that will be carried out for this purpose, which must be related to the application.

f. Criminal record certificate of the Applicant’s legal representative, its directors and partners, shareholders or members who have a stake greater than 6% of the company’s capital stock, through which it will be verified that they have not been declared criminally liable through a final conviction, for drug trafficking, money laundering, corruption and related crimes. In the event that the shareholders or partners are entities, the certificate of the last individuals in the chain of ownership must be filed, except if those entities are registered in a Stock Exchange, or in the case of an investment fund. In the case of foreign entities, they must file the equivalent document issued by the competent authority of the country of origin; duly legalized.

g. Document in which the organizational structure of the applicant and its members is detailed. In the event that the shareholders, partners or members are legal persons, the last natural persons in the chain of shareholders or partners of legal persons must be disclosed, except if those legal persons are registered in a Stock Exchange or in the case of an investment fund.

h. Form of legality and destination of funds.

i. Proof of payment of the government fee corresponding to the type of license applied, as detailed in the corresponding tariff list.

Here you can access the Ministerial Agreement N° 109-2020


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DISCLAIMER: The preceding text has been prepared for general information purposes only. CorralRosales is not responsible for any loss or damage caused as a result of having acted or stopped acting based on the information contained in this document. Any given situation requires the specific opinion and view of the firm in Quito / Guayaquil, Ecuador.





DATE: 19-05-2020


-Francisco Gallegos

MEDIA: LexLatin

In Ecuador, the use of cannabis is punishable, except in the case of personal consumption of quantities less than those established by the relevant law. At the end of last year, non-psychoactive and hemp cannabis were excluded from substances classed as subject to control, as will be explained further on, decriminalizing their use for medical or therapeutic ends (the exclusion thereby not extending to cannabis for recreational use).

Among the permitted uses are the possession of products that contain or are derived from cannabis for therapeutic, palliative or medicinal use, or whose use has medicinal objectives. In the same way, the law provides for the investigation, production, cultivation, distribution and sale of the substance, provided that the relevant government permits and approval are obtained and in accordance with the relevant requirements.

The reform will enter into force from June 21, 2020 and has as its overriding aim the elimination of punishments, excluding from control the possession of products for medicinal or therapeutic use that contain a non-psychoactive active ingredient or hemp (CBD), understood as the cannabis plant or any part thereof whose dry weight delta-9-tetrahydrocannabinol (THC) content is less than 1%, provided that there is a diagnosis of suffering from an illness or pain that merits its use. In relation to THC, the ingredient in marijuana that produces the psychotropic effect, this continues to be a controlled substance, if not found within the aforementioned parameters.

From a regulatory point of view, the National Agrarian Authority must issue the regulations relating to the importation, cultivation, planting, harvesting, selling, industrialisation and even exportation of non-psychoactive cannabis or hemp, within 120 days of the law entering into force. The regulation and control of the planting, cultivation and harvest will be the responsibility of the National Health Authority. To date there is no specific detail as to the relevant powers.

At this moment in time, according to the relevant decisions handed down by the Andean Community on the matter, the only CBD products eligible for marketing authorizations are cosmetic products for topical use, provided that they are contained within the international lists of ingredients that may be used within cosmetics and complying with the corresponding restrictions and conditions of use. Human consumption goods are not permitted. One must await the issuance of regulations from the competent authorities.

Moreover, it will be necessary to consider the final text of the Health Law that will also contain provisions as to the regulation of medical and therapeutic use cannabis and its derivatives. The draft law is currently awaiting its second reading.

From an intellectual property perspective, it is worth remembering that the relevant law does not specifically consider use of the word cannabis in the registration of a trademark; however, it is very important to keep in mind that Article 134 of Decision 486 of the Andean Community in its final section provides that the nature of the good or service to which a mark relates, will in no circumstances be an obstacle to registration.

This might mean that granting or refusal of an application for a trademark that includes the term “cannabis”, any derivative of or expression that refers to cannabis in the mark itself or within its coverage comes down simply to the individual criteria of the responsible IP Office examiner, given that, being a restricted product, it could lead to objections. To date there are differing opinions, without any clear position on the matter. In any event, the number of accepted cannabis trademark applications is much higher than those which have received official objections or oppositions from third parties.

Nevertheless, there are both cases of granted cannabis trademark applications, as well as applications which have received official objections. Therefore, it is very important to take care with the wording of the applied-for goods or services, with the aim of reducing the possibility of receiving an official objection. In the same way, it will be very important to consider the mark’s word elements as well as the elements making up the graphical part of the label, keeping in mind the absolute grounds for refusal as provided for by Article 135 section p) of Decision 486, corresponding to Article 360 section 18 of the Knowledge, Creativity and Innovation Law, also known as the Ingenuity Law, which provides for the refusal of marks contrary to law, morals, public order or decency.

At the start of this year, the Ecuadorian IP Office or SENADI as it is known locally according to its Spanish acronym, had processed a limited number of trademark applications and even fewer patent applications. It is reckoned, since there are no exact official figures, that a high proportion of such trademark applications have been accepted, in contrast with the patent applications whose application process is significantly longer.

It is important to point out that various associations of producers of hemp and its derivatives have been formed, as well as groups that lobby for the therapeutic use of cannabis in Ecuador, even some that have the support of the Public Defender’s Office, as an alternative means for those that suffer from catastrophic or chronic illnesses, such as palliative care against pain, epilepsy and other oncological or brain impairment problems.

CorralRosales has actively participated in various international forums about the different opportunities and challenges brought about by the use of cannabis for therapeutic and medicinal aims. The firm has also provided legal and regulatory advice for what is a nascent industry in Latin America.

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The use of cannabis has been approved in Ecuador


In the 1st Supplement of the Official Gazette No. 107 of December 24, 2019, the Reform of the Criminal Law was published, which will enter into force in June 21, 2020.

Included among the reforms, is the decriminalization of possession of drugs that contain cannabis or derivatives as their active ingredient for therapeutic, palliative or medicinal ends, or for the practice of alternative medicine. In addition, the Law of  Control and  Prevention of the use of  Drugs   has been amended, excluding non-psychoactive or hemp cannabis from control, extended to the cannabis plant or any part of the plant, whose delta-9-tetrahydrocannabinol (THC) content is less than 1%.

The Ministry of Agriculture will have 120 days from the entry into force of this law to issue the regulations to control the import, planting, cultivation, harvest, sale, industrialization and exportation of industrial hemp. Furthermore, shortly the National Assembly must approve the Health Law, in which cannabis and its derivatives for medicinal and therapeutic use will be regulated.