GUIDELINES TO OBTAIN CANNABIS LICENSES IN PERU
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In 2017, Peru’s marijuana laws changed to legalize marijuana, also known as cannabis, for medical purposes. In February this year, the government released official guidelines to issue licenses for the medical and therapeutic use of cannabis and its derivatives. In spite of this, further protocols were lacking before companies could apply for commercial cannabis licenses in Peru.
With the recent release of awaited protocols in November of this year, entities can now begin the process of applying for licenses to produce cannabis for commercial purposes.
Learn the general procedure to apply for cannabis licenses in Peru.
What are the types of commercial cannabis licenses in Peru?
Currently, Peru’s Law 30681 establishes three types of cannabis licenses:
- license for scientific research
- license for import and commercialization
- license for production.
The process to obtain cannabis licenses in Peru involves different government authorities that issue-specific certificates and authorizations that complement each other to obtain a license.
According to regulation, three entities are in charge of processing request for licenses and necessary documentation:
- the Ministry of Agriculture (MINAGRI), through the National Service of Agrarian Health (SENASA) and the National Institute of Agrarian Innovation (INIA). SENASA is in controls the imports of seeds and quarantine for cannabis post-entry.
- the Ministry of the Interior (MININTER), through its Anti-Drugs Directorate (DIRANDRO), is in charge of issuing safety protocols necessary for cannabis licenses in Peru.
- the Ministry of Health (MINSA), through the General Directive of Supplies and Drugs (DIGEMIN) and the National Institute of Health (INS). DIGEMIN is the authority that expedites production licenses and import and commercialization licenses as well. On the other hand, INS is in charge of expediting scientific licenses for medical research.
License for scientific research
The license for scientific research of cannabis in Peru is granted to universities accredited by the National Superintendence of Higher University Education (SUNEDU) and to other research institutions. The National Institute of Agrarian Innovation (INIA) takes charge of issuing scientific licenses for agrarian research and the National Health Institute (INS) is in charge of issuing licenses for medical research.
A license for medical research is divided into two: experimentation with humans, and non-human experimentation. A license for agrarian research isn’t divided into further categories.
General applications to obtain a scientific license include the following requests and documentation:
- 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
- a request of safety protocol issued by MININTER
- a request of the protocol of ethics issued by a Research Ethics Committee, if applicable
- Registration in the INS database, if applicable
These requests complement to obtain all necessary documentation for a scientific license and each request includes diverse paperwork.
Licenses for imports and commercialization
Getting authorization to import and commercialize cannabis products is a crucial opportunity for businesses to operate with cannabis licenses in Peru. This opens up the cannabis market to producing and distributing products for commercial purposes. With this license, Peru expects to develop its local consumer market.
This license can only be requested by natural, legal entities constituted as pharmaceutical establishments authorized by DIGEMID. The general procedure is as follows:
- a 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
- a request for good storage practice certification
- request for cannabis commercialization license, if applicable
For each request you make under this license, you’ll need to provide slightly different documentation. Generally, this will include certifications, customs paperwork, inspection, the hiring of a pharmaceutical chemist, among others.
Cannabis licenses in Peru: License for cannabis production
This type of license is divided into three types:
- Production license that includes the crop
- Production license that doesn’t include the crop
- Production license that includes seed production
This type of license can only be requested by natural, legal entities constituted as pharmaceutical establishments authorized by DIGEMID. The general procedure 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.
There are further documents involved in each request, including, hiring a pharmaceutical chemist, certifications, among others.
The recent approval of safety guidelines open doors for licenses
Although the procedure for cannabis licenses in Peru had been set, without guidelines regarding safety and imports, these protocols couldn’t be obtained. As a consequence, it wasn’t possible for businesses to obtain these cannabis licenses in Peru. Now that MININTER released a comprehensive set of safety guidelines for the medical and therapeutic use of cannabis, companies can begin the licensing process.
The newly established guidelines require the designation of an individual responsible for risk control in the applying business. These safety guidelines also require the implementation of a control system for the entry and exit of vehicles, raw materials, authorized personnel, among others.
Additionally, the safety protocol empowers the National Police. The Anti-Drug Directorate of the National Police (Dirandro), will now be able to inspect establishments, consequently, making sure all entities with licenses comply with security measures established.
Regarding imports, there are further guidelines that are yet to be released. However, companies can begin applying for other necessary certifications and authorization.
The attractiveness of getting cannabis licenses in Peru for business
Peru’s marijuana laws now open up significant opportunities for early-moving businesses and solidify its position as a main player in the region’s cannabis sector.
Production costs for medical marijuana are low, as labour is competitively priced and the land is cheaper as compared to other cannabis-producing countries. In addition, Peru’s overall climate allows for steady growth and maintaining of crops year-round, making your Peruvian cannabis crop reliable, consistent and highly productive.
According to data from market observers, one hectare of land cultivated with cannabis can produce 200 kilos. With an estimated price of US$5000 per kilo, a hectare of cannabis can be worth US$1 million in Peru.
With the new guidelines to obtain a license, early movers can begin profitable commercial activities in the country.
Obtain your cannabis licenses in Peru through Biz Latin Hub
Due to its steady economy, growth rate, and land profitability, Peru is a great option to start an agricultural business in cannabis production and commercialization. The cannabis industry in Latin America is booming, and Peru has now joined regional players such as Colombia. Peru is become more appealing due to its stability, continuous low risk, and land profitability. Since regulations to obtain licenses have been laid out, Cannabis businesses can now apply for them and conduct commercial activities.
At Biz Latin Hub, we have vast experience helping entrepreneurs from all over the world enter the Peruvian market. Our team of local lawyers and accountants is ready to assist with company incorporation, employee onboarding, commercial representation, visa services and more. Contact us today at [email protected] and get started in the Peruvian cannabis market.
Post available in: English