Peruvian authorities have published long-awaited guidelines governing the nation’s medical marijuana program, allowing companies to start applying for different types of business licenses spelled out under a 2017 law.
The new regulations mark the effective launch of Peru’s medical cannabis industry and create business opportunities for companies to produce medicine domestically and import products from overseas.
Government officials also announced that Peru’s first imported medical cannabis product has become available to patients.
Shipped from Anden Naturals, which has facilities in Lima, Peru, and West Linn, Oregon, the medical marijuana products are derived from hemp and available in 10-milliliter bottles.
The products have a CBD content of 48.75 milligrams per milliliter and a THC makeup of 0.449 milligrams per milliliter.
Guidelines key to ‘meaningful operations’
Andrés Vázquez Vargas, executive director at agribusiness consultancy ACM Peru, told Marijuana Business Daily that “the long-awaited guidelines just published allow businesses to really start having meaningful operations in the country.”
But as with any new country that comes online in the cannabis space, several issues need further regulation.
And some pending issues aren’t minor. For instance, it’s still unclear what procedures will be required to export medical cannabis from Peru to other countries.
“While there are always more details that regulators need to figure out, these guidelines represent the initial building blocks that will allow Peru to create a framework for companies to start capitalizing on different businesses opportunities, joining the global cannabis industry” Vázquez said.
A decree from early 2019 established some rules to implement the 2017 medical cannabis law. That decree, however, didn’t detail how companies could apply for licenses.
Types of licenses
Under Peru’s medical cannabis program, business licenses are available for research, wholesale import and commercialization, retail commercialization and production. The number of licenses is not capped.
Companies interested in applying for licenses should be aware that many of the rules that apply to cannabis are general health-care regulations. This is specifically the case for import and commercialization.
The types of production licenses currently available both include and exclude cultivation. A license also is available for seed production.
Agricultural production plan
To obtain a production license, including cultivation, an agricultural production plan must be submitted. The plan must detail the production process from sow to harvest.
Only pharmaceutical laboratories authorized by the General Directorate of Medicines, Supplies and Drugs (DIGEMID), part of the Ministry of Health, or public entities are allowed to apply for a production license.
Among other requirements, the plan must include:
- The procedures that will be implemented at the production site.
- An estimate of the necessary seeds or clones that will be used.
- The genetic material’s origin.
- The technical specification of the inputs that will be used during production.
The Ministry of Agriculture (MINAGRI) is responsible for collecting, evaluating and approving the plans.
Other requirements include:
- Indicating what will happen with the crops after harvest, and where they will be sold, processed or used for research.
- Appointing a technical person, as well as detailing a list of the staff that will handle the crop. Employees who handle the crop cannot have criminal records related to drugs.
- A detailed agronomic plan covering all agricultural processes, including the number and kilograms of seeds to be used, estimated kilograms of flower to be produced, area to be grown, product descriptions, a description of the field and installations, and more.
- Documentation proving ownership of the land where the crop will be grown, or a lease agreement.
- A detailed description of the location, including the names of the owners of neighboring fields.
- A security protocol.
The Agricultural Direction of the MINAGRI has seven working days to evaluate the plans. The agency can issue comments but must give applicants five working days to address them.
Once the plan is approved by the Agricultural Direction, the General Agricultural Direction of MINAGRI has three working days to issue the approving resolution.
To obtain a research, production or commercialization license, applicants must submit a security plan according to the published guidelines.
The Anti-Narcotics Unit of the Ministry of Interior (DIRANDRO) is responsible for approving such plans, which must detail measures to prevent diversion of the plants or products to the illicit market.
The plans must also include a diagnosis of vulnerabilities, the design of risk-control mechanisms and measures for monitoring and evaluation.
Depending on the type of license, the approval of the security protocol could be automatic or could require an evaluation that includes on-site inspection.
The security protocols for most of the different research and commercialization licenses are approved automatically. Those for agronomical research licenses or production licenses require an evaluation.
Also last week, Peruvian authorities published regulations allowing holders of a production or a research license to begin importing seeds from Colombia, among other countries.
At least for now, a unique authorization to import seeds must be obtained before each sowing. Seed propagation is prohibited.
Any seeds to be imported require a phytosanitary certificate stating that they are free of certain plagues; there’s a different list depending on the country they come from.
When the seeds arrive in Peru, they must be quarantined for two months, during which time authorities will inspect them.
Alfredo Pascual can be reached at [email protected]