How to get a Cannabis License in Peru

Could Peru be the next cannabis hot spot in Latin America?

Medical cannabis has been legal in Peru since 2017. Yet, the South American country has been slow to regulate and implement comprehensive marijuana programs. Groups of patients have historically provided Peruvian medical marijuana patients with access but changes may be on the horizon.

Cannabis legalization has become a major trend in Latin America. The climate makes it very suitable for production as nations like Peru are capable of producing up to five harvests per year. With this hospitable natural climate, it makes sense for countries like Canada to import cannabis from regions that require less energy input to combat cooler climates where cannabis plants do not thrive as well. Indeed, the cannabis market is gradually globalizing and Peru could be another player on the rise. Continue reading for a comprehensive guide to help you become a licensed cannabis producer in Peru.

Cannabis Legalization and Commercialization in Peru

The lack of regulation and absence of formalized medical marijuana programs in Peru means that there have been minimal business opportunities. Peru decriminalised marijuana possession of up to 8 grams for personal consumption, yet that does not mean there are easy legal channels to obtain the flower. Basically, patients struggle to access legal cannabis. Current legislation allows pharmaceutical laboratories to produce medical cannabis, but few have taken advantage of this option. A 2022 article from High Times reported that The Peruvian Ministry of Health (MINSA) is currently seeking public opinion to help shape an anticipated update to Peru’s marijuana laws [1].

Cannabis legalization has become a major trend in Latin America. The climate makes it very suitable for production as nations like Peru are capable of producing up to five harvests per year.

Through future legislation, patient collectives hope to maintain their ability to provide cannabis access. However, the limited number of collectives means that many patients are still left out. Because of this, it is likely that Peru will offer more opportunities to commercial cannabis growers in the near future. Canopy Growth, Plena Global, VerdeMed Pharma, and a few other companies approved their products in 2021. As of 2022, only one reported pharmacy in Peru dispenses medical cannabis [4]. However, it has been reported that over 7,000 people urgently need access to medical cannabis [3]. The medical conditions that allow for prescribing of cannabis include nausea and vomiting from chemotherapy, weight loss and appetite loss due to cancer or HIV, seizures, and pains and spasms related to multiple sclerosis.

Cannabis Regulations in Peru

Law N° 30681 was enacted in November 2017 and made it legal for individuals and companies to use, investigate, produce, import and commercialize cannabis and cannabinoid products for medical purposes [2,3]. Regulations of Law N° 3068 (Decree 005-2019-SA) were published in 2019. The regulations distinguish between hemp and marijuana with hemp (non-psychoactive cannabis) being defined as having less than 1% tetrahydrocannabinol (THC). Since few hemp and CBD products are regulated, an unregulated CBD market has risen which is somewhat problematic for the push for further cannabis legislation[4].

Recreational Cannabis is Decriminalized

As a part of Law N° 30681, personal possession of cannabis was decriminalized for up to 8 grams. This was done for two reasons:

• It allows law enforcement agencies to focus their efforts on tackling illicit drug trafficking, and large-scale cannabis possession offenses
• It gives more freedom to Peruvians, as it’s estimated that 12% of Peruvian students have used cannabis, or marijuana in their lifetime.

Peru is Shifting to a More Lenient Drug Use Policy

Peru is also shifting their approach from drug enforcement, to promoting safe drug use. This is a big shift from the 1980-1990s era Peruvian policies which took a hard stance against cannabis, with their “just say no” campaigns. Article 299 of the Peruvian Penal Code allows up to:

• 5 grams of cocaine basic paste
• 2 grams of cocaine hydrochloride
• 1 gram of opium latex, or 200 milligrams of its derivatives
• 250 milligrams of ecstacy, containing:
  • Methylenedioxyamphetamine (MDA)
  • Methylenedioxymethamphetamine (MDMA)
  • Methamphetamine or similar substances

Peru is Still Developing Cannabis Related Regulations

On September 1, 2023, the Peruvian government updated its legislation to further regulate the medicinal and therapeutic use of cannabis and its derivatives. They did so, by passing the Supreme Decree No. 004-2023-SA. The new regulation:

• Strengthens the regulation, scope, and coverage for the use of cannabis and its derivatives for medical and therapeutic purposes
• More specifically regulates the manner, parameters, and/or requirements so that those who are administered can now carry out research, production, importation, and commercialization of cannabis and its derivatives and artisanal production of cannabis derivatives with associative cultivation.

We will likely see further developments and regulations being introduced into Peru so that the market can continue to evolve.

Getting a Cannabis License in Peru

Peruvian law has three types of cannabis licenses [2,3]. There are licenses for scientific investigation, licenses for import and trade, and licenses for production. The cannabis production license may be granted to public entities and certified pharmaceutical laboratories. This means that a cannabis grower must be a certified laboratory, which is not how most cannabis growers organize their business in Canada or the US. Requirements for applying for a cannabis license in Peru are not entirely clear, but it has been reported that detailed information such as agricultural production plans and security protocols are required [4].

General Overview of Licensing Requirements

To get a cannabis production license in Peru, the endeavour has to begin with starting a certified pharmaceutical laboratory. This means working with multiple ministries that seem to lack a streamlined process [3]. The first ministry of concern is The Ministry of Health division Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) which has authority over the production, importation and commercialization licensing processes. Cannabis research licenses in Peru are administered by The Ministry of Agriculture’s Instituto Nacional de Innovación Agraria (INIA). Cannabis security-related issues are the responsibility of The Ministry of Interior’s Dirección Antidrogas (Dirandro). The Ministry of Agriculture Servicio Nacional de Sanidad Agraria (SENASA) is responsible for regulating cannabis seeds which may be imported from Colombia or the US [3,4].

Cannabis Companies Must Be Certified Pharmaceutical Laboratories

Since cannabis companies in Peru must be certified pharmaceutical laboratories, the cannabis products that are produced are also handled differently. Cannabis products must have sanitary registration with the Health Ministry, DIGEMID [3]. They may also be dispensed as an imported product with special authorization for individual use, or as magistral preparations for individual treatment, prepared by a pharmaceutical chemist in an authorized pharmacy or equivalent. Cannabis biomass leftovers are not allowed to be used or re-purposed and must be incinerated [4].

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Steps to Apply for Commercial Cannabis Licenses in Peru

License for Scientific Research

The National Institute of Agrarian Innovation is in charge of issuing scientific licenses for agrarian research, and the National Health Institute (INS) is in charge of issuing licenses for medical research. General applications to obtain a scientific license require the following:

• Request for authorization for clinical trial emitted by INS
• In the case of products manufactured nationally, a laboratory certificate
• In case of utilizing imports, it is necessary to present a directorial resolution of authorization for imports issued by DIGEMID
• The request of safety protocol issued by MININTER
• Request of protocol of ethics issued by a Research Ethics Committee, if applicable
• Registration in the INS database, if applicable

Licenses for Imports and Commercialization

Gaining the ability to import, and commercialize cannabis products is one of the first milestones in building a viable cannabis company in Peru. The country is using these license holders to develop their local markets. The license can only be requested by natural, legal entities which are constituted as pharmaceutical establishments authorized by DIGEMID. Here are the steps to acquire an import, and commercialization license in Peru:

• Request of import license for cannabis derivatives for medical use
• Request registration in SENASA import registry
• Request a laboratory safety protocol from DIRANDO
• Request the production/commercialization license from DIGEMID
• Request of good storage practice certification
• Request for cannabis commercialization license, if applicable

License for Cannabis Production

This license is divided into three broad types: production licenses that include the crop, production licenses that don’t include the crop, and production licenses that include seed production.

These licenses are also authorized by DIGEMID, and the general process to apply for the licenses is as follows:

• Agricultural production plan approved by MINAGRI, if applicable
• document proving the origin of the genetic material to be used, countersigned by MINAGRI
• Safety protocol for cultivation, planting, handling and harvesting issued by MININTER
• Safety protocol for manufacture issued by MININTER
• Production plan for the manufacturing of derivatives
• Cannabis waste disposal plan.

Companies Participating in the Peruvian Cannabis Industry

While the cannabis licensing process is still being developed, and streamlined, here are a few notable cannabis companies that have started to develop the Peruvian Cannabis industry.

Plena Global Acquires a 26M Square Foot Organic Farm

Plena Global is a Canadian-based cannabis production company that has signed a letter of intent to acquire a 26 million square foot organic farm in Peru so that they can further scale their efforts to build a presence in the LATAM region. According to Plena Global’s CEO, Richard Zwicky, “Peru represents the world’s best-growing region for agricultural products, without peer”.

Cannabis & Co., Opens up Cannabis-Focused Drug Stores

Cannabis & Co., annual sales exceeded one million soles at the end of 2022, in their first year of operations. The company is playing a key role in building, and developing the cannabis market in Peru. In fact, they are forecasting 30% sales growth by the end of 2023.

Canopy Growth Sets up Operations in Peru

Canadian-based Canopy Growth has expanded its LATAM subsidiary, Spectrum Therapeutics, to operate in Peru as well. The company already cultivates cannabis in Columbia and is playing a key role in developing the Peruvian market as well. The company is currently in the process of getting approval for a wave of new products. Spectrum Therapeutics has been able to successfully import CBD oil in bulk, and once they acquire the requisite approvals, they will be ready to start distributing their products as well.

Cannabis in Peru: Looking Forward

Starting a cannabis business in Peru may seem like a daunting process, but when you work with expert consultants like GrowerIQ you’ll have the support and software you need to satisfy regulators. Latin America is a new frontier in the cannabis industry with abundant opportunities to explore. Big cannabis firms are already moving into Peru, so this is a great time to start the application process.

The mere fact that you found your way to this article is remarkable, we’re sure that you’re an ambitious grower. The oppourtunity in international trade does not end here. We have written guides on getting your cannabis license for more countries, such as Argentina, St. Vincent, Switzerland, and Denmark. Check out our guides over here: Cannabis License in Argentina, How to Get a Cannabis License in St. Vincent, How to Get a Cannabis License in Switzerland, and Cannabis License in Denmark.

Find out more

Peru has a long way to go before its government considers legalizing recreational cannabis. For now, businesses can only sell via approved Peruvian laboratories with one of the three approved types of licenses. Sounds complicated? GrowerIQ makes the application simple. Click the button below or fill out the sign-up form to get in touch with our experts.

References

1. Arnold, M. (2022, May 31). Peru Issues Draft Law to Allow and Regulate Patient-Grown Medical Cannabis. Retrieved June 22, 2022, from High Times website: https://hightimes.com/news/peru-issues-draft-law-to-allow-and-regulate-patient-grown-medical-cannabis/
2. Cannabis law and legislation in Peru. CMS Expert Guides. (2019). Retrieved June 22, 2022, from Cms. law website: https://cms.law/en/int/expert-guides/cms-expert-guide-to-a-legal-roadmap-to-cannabis/peru
3. Pascual, A. (2019). Cannabis in Latin America: The Regulations and Opportunities. Marijuana Business Daily. Retrieved July 24, 2021, from https://mjbizdaily.com/wp-content/uploads/2019/09/Cannabis-in-Latin-America_The-Regulations-and-Opportunities.pdf
4. The LATAM and Caribbean Report. Prohibition Partners. (2020, November). Latin America and Caribbean Cannabis Report Second Edition from: https://prohibitionpartners.com/reports/the-latin-america-and-caribbean-cannabis-report-second-edition