CANNABIS: FOR MEDICAL PURPOSES AND OTHERS

Legality of medical cannabis in Peru arose in October 2017 pursuant to Act No. 30681, regulating medical and therapeutic cannabis and byproducts. Pursuant this Law, a regulated research, import, trade and production system for cannabis and byproducts for medical and therapeutic purpose only was established.

In order to enforce Act No. 30681, its draft regulations was issued on May 16, 2018 by the Resolution of the Minister’s Office No. 435-2018/MINSA to receive suggestions, comments and recommendations of public or private entities as well as the citizenship in general for a ninety (90) business-day term due in August 2018.

Such draft regulations were prepared by a Multi-Sectoral Committee created as per Supreme Executive Resolution No. 003-2018-SA. This Committee was made up of representatives from 10 entities and presided by a representative officer from the Public Health Vice-Ministry of the Ministry of Health.

On Saturday, February 23, 2019, the expected Medical Cannabis Regulations were issued by virtue of Supreme Executive Order No. 005-2019-SA. Amendments to the 2018 version represent significant positive changes for patients’ access to treatment and; consequently, regulations viability and enforcement.

Some positive aspects of the Regulations:

Cannabis is no longer a forbidden drug in the country.

As it is no longer a forbidden drug, its entry to the country is permitted not only as medical cannabis but also products such as cosmetics, food and beverages for human consumption, as well as animal health products. It should be mentioned that the definition of non-psychoactive cannabis should be complied with for the latter products.

Psychoactive and Non-Psychoactive Cannabis are distinguished.

A cannabis fact in respect to the variety of cannabinoids is provided by the Regulations, identifying psychoactive and non-psychoactive substances.

Therefore, the psychoactive cannabis end products shall be for medical purposes only. In case of non-psychoactive cannabis end products, they shall not have restrictions.

In fact, non-psychoactive cannabis refers to cannabis of less than 1% THC dry weight as set forth in the Regulations. Thus, they are non-controlled substances and are excluded from the Narcotic Drugs and Psychotropic Substances Regulations enforcement.

Extraordinary authorization for patients.

Patients shall directly import cannabis products by a special prescription and the authorization issued by the General Medicine, Supplies and Drug Administration – DIGEMID.

In fact, the Regulations do establish the possibility of the extraordinary import of products containing cannabis, resins and essential oils for medical purposes only upon approval of the National Patient Registry for Medical and Therapeutic Cannabis and Byproducts, as well as the special prescription that will correspond to a 6-month-treatment term.

Compounded drugs.

Compounded drugs are pharmaceutical preparations tailored for an individual patient by a licensed Pharmacist or under his supervision in strict compliance with a detailed medical prescription or the active ingredients as per technical and scientific standards in terms of pharmacy. They are dispensed by pharmacies and those placed in public or private hospitals.[1]

Compounded drugs should be prepared upon presentation of the pertinent prescription and are exclusively dispensed by the pharmacy receiving such prescription. They must not be kept in stock and their mass creation is forbidden.

Pharmacy dispensing compounded drugs may prepare them directly or request their preparation to a specialized pharmacy. In this case, compounded drug preparation responsibility is assumed by the dispensing pharmacy and the specialized pharmacy to which preparation was requested.

For compounded drugs, wholesale or end products must not be used as supplies. Compounded drugs containing substances subject to health control shall comply with the Regulations on Narcotic Drugs, Psychotropic Substances and Other Substances.

Therefore, it shall be established that compounded drugs of cannabis byproducts will be created from standardized cannabis byproducts supplies. It is understood that such supplies, not being end products, do not required export and trade health registry.

International trade: export.

The Act No. 30681 provided that Regulations shall establish the requirements for the registry enforcement and license issuance which, in compliance with the legal system and the Law, may not restrict provisions thereof.

In this respect, Regulations of the Act No. 30681 included international trade: export as an activity fostering economies of scale, use of resources and materials, and a consequent production cost reduction deriving benefits to patients in the end. As set forth in the Regulations, the Official Export Certificate shall comply with the provisions of the Regulations on Narcotic Drugs, Psychotropic Substances and Other Substances subject to health control.

Health Registry for products containing cannabis.

Registry for products as herbal medicines and natural products is allowed. Each category difference shall referred in the presentation of safety and efficacy clinical trials. Only for herbal medicines, therapeutic effect may be indicated in labelling and/or marketing aimed at healthcare professionals.

Finally, it should be mentioned that regulations viability and its immediate enforcement for the sake of patients will depend on the authorities’ working together and the timely issuance of licenses and health registry.

[1] Supreme Executive Order (D.S.) No. 014-2011-SA. Section 2: Definitions. Item 37

For more information, please contact Maritza Reátegui (mreategui@estudiorodrigo.com) or Solange Noriega (snoriega@estudiorodrigo.com).


 

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