What are the types of commercial cannabis licenses in Peru?
Currently, Law 30681 of Peru establishes three types of cannabis licenses:
license for scientific research
import and marketing license
license for production.
The process to obtain cannabis licenses in Peru involves different government authorities issuing specific certificates and authorizations that complement each other to obtain a license.
According to the regulation, three entities are in charge of processing the license application and the necessary documentation:
the Ministry of Agriculture (MINAGRI), through the National Agrarian Health Service (SENASA) and the National Institute of Agrarian Innovation (INIA). SENASA controls seed imports and post-entry quarantine for cannabis.
The Ministry of the Interior ( MINISTER ), through its Anti-Drug Directorate (DIRANDRO), is in charge of issuing the security protocols necessary for cannabis licenses in Peru.
the Ministry of Health (MINSA), through the General Directive of Supplies and Medicines (DIGEMIN) and the National Institute of Health (INS). DIGEMIN is the authority that streamlines production licenses and import and marketing licenses as well. On the other hand, the INS is in charge of expediting scientific licenses for medical research.
1. License for scientific research
The license for scientific research on cannabis in Peru is granted to universities accredited by the National Superintendency of Higher University Education (SUNEDU) and to other research institutions. The National Institute of Agrarian Innovation (INIA) is in charge of issuing scientific licenses for agricultural research and the National Institute of Health (INS) is in charge of issuing licenses for medical research.
A license for medical research is divided into two: human experimentation and non-human experimentation. A license for agricultural research is not divided into other categories.
General applications for obtaining a scientific license include the following applications and documentation:
• Application for authorization for clinical trial issued by the INS
• In the case of domestically manufactured products, a laboratory certificate
• In case of using imports, it is necessary to present a resolution of authorization of address for imports issued by DIGEMID
• security protocol request issued by MINISTER
• Ethics protocol request issued by a Research Ethics Committee, if applicable
• Registration in the INS database, if applicable
These applications are complemented to obtain all the necessary documentation for a scientific license and each application includes diverse documentation.
2. Import and marketing licenses
Obtaining authorization to import and commercialize cannabis products is a crucial opportunity for companies to operate with cannabis licenses in Peru. This opens the cannabis market to the production and distribution of products for commercial purposes. With this license, Peru hopes to develop its local consumer market.
This license can only be requested by natural, legal persons constituted as pharmaceutical establishments authorized by DIGEMID. The general procedure is as follows:
application for a license to import cannabis derivatives for medical use
request registration in the imported registry of SENASA
request a laboratory security protocol from DIRANDO
Application for the production/commercialization license of DIGEMID
request for certification of good storage practices
application for a cannabis marketing license, if applicable
For each request you make under this license, you will need to provide slightly different documentation. Generally, this will include certifications, customs documentation, inspection, hiring a pharmaceutical chemist, among others.
3. License for cannabis production
This type of license is divided into three types.
Production license that includes cultivation.
Production license that does not include cultivation.
Production license that includes the production of seeds.
This type of license can only be requested by natural persons, legal entities constituted as pharmaceutical establishments authorized by DIGEMID. The general procedure is as follows:
Agricultural production plan approved by MINAGRI, if applicable
a document that proves the origin of the genetic material to be used, endorsed by MINAGRI
Safety protocol for cultivation, planting, handling, and harvest issued by MINISTER
Safety protocol for manufacturing issued by MINISTER
Production plan for the manufacture of derivatives.
Cannabis waste disposal plan.
There are more documents involved in each application, including hiring a pharmaceutical chemist, certifications, and more.
The recent approval of security guidelines opens doors for licenses
Although the procedure for cannabis licenses in Peru had been established, without guidelines on safety and imports, these protocols could not be obtained. As a consequence, it was not possible for companies to obtain these cannabis licenses in Peru. Now that MINISTER has released a comprehensive set of safety guidelines for the medical and therapeutic use of cannabis, companies can begin the licensing process.
The recently established guidelines require the appointment of an individual responsible for risk control in the applicant 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.
In addition, the security protocol empowers the National Police, the Anti-Drug Directorate of the National Police (Dirandro) will now be able to inspect the establishments, consequently, ensuring that all entities with licenses comply with the established security measures.
Regarding imports, there are other guidelines that have not yet been published. However, companies can start applying for other necessary certifications and authorizations.
The lure of obtaining cannabis licenses in Peru for business
Las leyes de marihuana de Perú ahora abren oportunidades significativas para las empresas que se mueven temprano y solidifican su posición como un actor principal en el sector de cannabis de la región.
Los costos de producción de marihuana medicinal son bajos, ya que la mano de obra tiene un precio competitivo y la tierra es más barata en comparación con otros países productores de cannabis. Además, el clima general de Perú permite un crecimiento constante y el mantenimiento de los cultivos durante todo el año, lo que hace que su cultivo de cannabis peruano sea confiable, consistente y altamente productivo.
Según datos de observadores del mercado, una hectárea de tierra cultivada con cannabis podría valer 12 veces su inversión original, de $ 120,000 a $ 1.5 millones.
Con las nuevas pautas para obtener una licencia, los primeros pueden comenzar actividades comerciales rentables en el país.
Obtenga sus licencias de cannabis en Perú a través de Biz Latin Hub
Debido a su economía estable, tasa de crecimiento y rentabilidad de la tierra, Perú es una gran opción para comenzar un negocio agrícola en la producción y comercialización de cannabis. La industria del cannabis en América Latina está en auge, y Perú ahora se ha unido a jugadores regionales como Colombia. Perú se ha vuelto más atractivo debido a su estabilidad, bajo riesgo continuo y rentabilidad de la tierra. Dado que se han establecido regulaciones para obtener licencias, las empresas de cannabis ahora pueden solicitarlas y realizar actividades comerciales.
En Biz Latin Hub, tenemos una vasta experiencia ayudando a emprendedores de todo el mundo a ingresar al mercado peruano. Nuestro equipo de abogados y contadores locales está listo para ayudar con la incorporación de empresa, la incorporación de empleados, la representación comercial, los servicios de visa y más. Contáctanos hoy aqua y comienza en el mercado peruano de cannabis.