This guide offers a cross-border analysis on the current state of regulation for various cannabis products, including medical marijuana, recreational marijuana, hemp, and CBD, as well as details on any applicable financial incentives, special tax considerations, and investment limitations.
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The use of cannabis and its byproducts is legal for medicinal and therapeutical use in Peru. In effect, Peru issues licences to carry out activities related to the research, production, import, and marketing of cannabis and its byproducts for medicinal use, exclusively intended for medicinal and therapeutical use.
A production license entitles the holder to carry out the following activities: acquisition of seeds and/or seedlings, sowing, spreading, farming, harvest, post-harvesting, manufacture of cannabis byproducts, as well as activities of storage and transportation of seeds, seedlings, plants, flowers, and byproducts of cannabis for medicinal use.
There are three production licenses in Peru:
The production license that includes farming is granted to public agencies or laboratories authorized and certified by the General Bureau for Medicines, Drugs and Inputs (DIGEMID), which must first meet the conditions set forth in the Regulation for Pharmaceutical Establishements, approved by Supreme Decree N° 014-2011-SA, as well as the following requirements:
a) Form of application for Cannabis production license for medicinal use and its byproducts for medicinal and therapeutical use, as in the form published in the DIGEMID website. Such form must be signed by the technical director and legal representative of the pharmaceutical establishment or public agency, accordingly.
b) A copy of the Agricultural Production Plan authorized by the competent authority of the Ministry of Agriculture and Irrigation (MINAGRI).
c) A copy of the document proving the origin of the genetic material to be used, endorsed by MINAGRI.
d) A copy of the security protocol approved by the Ministry of Internal Affiars (MININTER) for farming, sowing, management, and harvesting of cannabis for medicinal purposes.
e) A copy of the security protocol approved by MININTER for the manufacture of cannabis byproducts for medicinal purposes.
f) A copy of the production plan for the manufacture of cannabis byproducts for medicinal use and cannabis-containing products.
g) A copy of the medicinal cannabis waste disposal plan to be implemented during the production process.
h) An affidavit for the legal representative and security and management-related persons that they have no police, criminal, or judicial records for illicit drug trafficking and related activities.
With regard to the application for a production license that does not include farming, the applicant is exempt from meeting requirements b), c) and d) contained in 3.a., but it is required to attach the Analysis Certificate of the raw material or extract, issued by the manufacturer.
With regard to the application for a production license that does not include farming, the applicant is exempt from meeting requirements b), c) and d) contained in 3.a., but it is required to attach the Analysis Certificate of the raw material or extract, issued by the manufacturer.
The marketing and/or import license of cannabis for medicinal use and the marketing and/or import license of cannabis byproducts for medicinal and therapeutical use are granted to individuals or legal entities organized as pharmaceutical establishments authorized and certified by DIGEMID and meeting the conditions contained in the Regulations for Pharmaceutical Establishments approved by Supreme Decree N° 014-2011-SA.
The requirements for a marketing and/or import license are as follows:
a) Form of application for a marketing license of cannabis byproducts for medicinal use as in the model published in the DIGEMID website, signed by the technical director and legal representatives of the pharmaceutical establishment.
b) An affidavit of exclusive sale to patients registered as users of cannabis and its byproducts for medicinal and therapeutical use.
c) A copy of the security protocol approved by MININTER as established in the Regulations.
d) An affidavit from the legal representative and security and management-related persons that they have no police, criminal, or judicial records for illicit drug trafficking and related activities.
Limitations are placed on the marketing of cannabis and its byproducts at home or online, as well as marketing or distribution of pharmaceutical preparations in health professionals’ offices and outside the authorized and certified pharmaceutical establishment.
In addition, the promotion and advertising of cannabis for medicinal use and its byproducts as medical samples or originals for gift are prohibited.
Item 3.a. also applies to cannabis byproducts for medicinal use. In this sense, byproducts are any compound, mixture or preparation, or product derived from cannabis for medicinal purposes, such as herbal medicine, pharmaceutical preparation, pharmaceutical product, and natural product for health use
With regard to import and/or marketing licenses, the pharmaceutical establishment applying for the license is required to be authorized and certified by DIGEMID. With regard to production licenses, Security Protocol (a requisite to apply for this license) must be verified and approved by the corresponding authorities and is subject to review by the representative of the Drug Enforcement Agency (DIRANDRO) of the Peruvian Police Force. A prerequisite for such approval is to obtain the Municipal Operation License number.
Impacts will be measured at a medium term because the rules of legality of cannabis and its byproducts have been recently published, and the most impacted sectors are agriculture, economy, labor, and medicine.
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The activities of research, agricultural production, industrialization, import, and marketing of hemp, its parts and byproducts, do not require any licenses.
Please see 1.1
Please see 1.1
If the formula only contains CBD, it is sold and/or distributed with a prescription.
A marketing license is not required.
Please see 1.5
It is sold and/or distributed only with a prescription, if the formula registration indicates that it is made with CBD only; otherwise, a special prescription will be required because it is a cannabis byproducts.
Please see 1.7.
Please see 1.8.
Yes.
Please see 1.1.
Please see 1.1.
If the formula only contains CBD, it is sold and/or distributed with a prescription.
A marketing license is not required. If the formula only contains CBD, it is sold and/or distributed with a prescription.
Please see 1.5.
It is sold and/or distributed only with a prescription, if the formula registration indicates that it is made with CBD only; otherwise, a special prescription will be required because it is a cannabis byproducts
Please see 1.7.
Please see 1.8.
The main agencies involved in regulation of cannabis and its byproducts are as follows: (i) the Ministry of Health (MINSA) acting by and through the General Bureau for Medicines, Drugs and Inputs (DIGEMID) and the National Health Institute; (ii) the Ministry of Agriculture and Irrigation (MINAGRI); and (iii) the Ministry of Internal Affairs (MININTER).
The main rules regulating cannabis and its byproducts are as follows: Act N° 30681 (Law regulating the medicinal and therapeutical use of cannabis and its byproducts) and its Regulation (Supreme Decree N° 005-2019-SA).
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This aspect should be measured in the coming years. It is important to note that the Regulation of the Law governing the medicinal and therapeutical use of cannabis and its byproducts has been recently published in March 2019. The application of the rule is at a very early stage.
At present, everything is focused on the import because the rule is new.
In the next five years, Peru may become one important producer for export purposes.
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Disclaimer: This guide contains summaries of general principles of law. It is not a substitute for specific legal advice and should not be relied upon in relation to the application of the law or subject matter covered.
