According to Peru’s regulation of Law N° 30681 that legalized the medicinal and therapeutic use of cannabis and its derivatives, business can produce cannabis for: production, import, commercialization and research.
As this is a newly decriminalized industry in Peru, the procedure, requirements and documentation are still being finalized by local government institutions for approval and publication.
The three main entities involved are co-dependent for the authorization and licenses of this new activity. They are the following:
- Ministry of Agriculture through SENASA (National Agricultural Safety Service) and INIA (National Agricultural Innovation Institute),
- Ministry of Internal Affairs through the DIRANDRO (Anti-Drug Directorate) and finally,
- Ministry of Health through DIGEMID (General Directorate of Medicines, Supplies and Drugs).
Import and commercialization license
The import and commercialization license for cannabis and its derivatives currently only allows medicinal and therapeutic use of the products.
This license can be requested by natural persons or legal entities, or pharmaceutical establishments authorized by DIGEMID.
In general terms, to this license, you’ll need to undertake the following steps with your business:
- Request registration in the Import Registry to SENASA
- Request a Laboratory Safety Protocol from DIRANDRO
- Apply for the Production/Commercialization License to DIGEMID.
At each stage you’ll be required to provide permissions, certifications, customs procedures, inspections, and specialized technical documentation to support your applications. This includes:
- Certificate of origin
- Phytosanitary certificate
- Laboratory tests.
(These are just some of the documents needed that we were informed when we called to the entities, but can’t specify more as the requirements and the whole procedure haven’t been published yet.)
Also, you must appoint and partner with a Pharmaceutical Chemist who will be in charge of the whole process, and act as the responsible technical expert before DIGEMID.
Currently, this process takes around 12 months to complete.
Production license details
In Peru, the scope of production activity includes the two types of cannabis: non-psychoactive and psychoactive cannabis. The production license is only granted to public entities or laboratories authorized and certified by the Ministry of Health through DIGEMID.
The Ministry of Agriculture gives 3 types of licenses for producing cannabis in Peru:
- Production license that includes cultivation
- Production license that does not include cultivation
- Production license that includes seed production
This activity involves the creation of a Pharmaceutical Laboratory, duly authorized by the Ministry of Health (DIGEMID). Businesses will need to appoint 4 qualified Pharmaceutical Chemists for the creation and ongoing operation of this Pharmaceutical Laboratory.
Buying land for cultivation
If the production activity includes cultivation, your company will need to purchase a piece of land that fulfills the requirements set by the Ministry of Agriculture. In addition, you’ll need to work with an Agricultural Engineer Consultant for this step of the process.
Regulations on distribution
If your proposed production activity includes distribution of cannabis products, you’ll need to identify and purchase/lease an appropriate retail outlet – a pharmaceutical store. This process can take approximately 60 working days to complete. Each product you intend to distribute must also be registered in the Health Registration. This registration process can take 4 months approximately.
During this process, you must work alongside a Pharmaceutical Chemist who has been recognized by the DIGEMID as the responsible partner for the production of cannabis.
Note that for the production license, you’ll also need to produce and present a number of documents, including the following:
- an agricultural production plan
- approved safety protocols
- a cannabis waste management plan
- license and other certificates
- confirmations of inspections and outcomes
- Municipal licenses
- other specialized technical documentation
Currently, the estimated time for creating a Pharmaceutical Laboratory is not yet determinable.
Pending guidelines for non-psychoactive cannabis
The decree that outlines regulations for the production of non-psychoactive cannabis hasn’t been approved and published yet by the Peruvian government. These guidelines are noted by the Ministry of Internal Affairs as pending for publication.
Reach out for advice
The Peruvian government has yet to fully publish a comprehensive framework for producing, manufacturing, distributing and exporting cannabis. But we’re ready for when they do, and we can help you prepare for imminent expansion.
At Biz Latin Hub, we’re at the forefront of Colombia’s booming cannabis industry, and our Peruvian office and cannabis expertise positions us perfectly to support incoming investors and entrepreneurs in the wider Latin American cannabis market. Our suite of tailored market entry and back-office services, including legal and commercial representation,
Reach out to us today at [email protected] to start planning your expansion into Peru’s emerging cannabis market.