In brief

Supreme Decree No. 004-2023-SA approved the new “Regulations governing the Medicinal and Therapeutic Use of Cannabis and its Derivatives,” which will enter into force on 1 September 2023.

In depth

What are the main novelties?

Associations of cannabis user patients (two or more patients) are allowed for the exclusive benefit of their members, who must be registered in the Registry of Cannabis User Patients.

Artisanal production with associative cultivation is allowed if activity is carried out by and for the benefit of the associations of cannabis patients.

Cannabis and its derivatives from artisanal production with associative cultivation are for the exclusive use of the patients of the associations, so they cannot be commercialized or transferred to third parties.

The Ministry of the Interior, through the Anti-Drug Directorate, is included as the controlling authority with respect to the security and physical intangibility of cannabis and its derivatives, as well as the finished product.

The regional governments are included, through the regional health directorates or those that take their place at the regional level, as the controlling authority for importation, commercialization, artisanal production with associative cultivation of pharmaceutical establishments, and associations of cannabis user patients in their jurisdictions.

The grounds for suspending and canceling licenses have been expanded, and among these, it is specified that submitting false information is subject to cancellation and that failing to communicate modifications to the declared information is subject to suspension.

The similarities between the licenses regulated by the new regulation and those granted under the old regulation are specified. Likewise, licenses granted under the old regulation must comply with the provisions of the new regulation within one year from its entry into force, under penalty of cancellation.

License holders for production with cultivation must implement records of sowing, harvesting, destruction and management of cannabis residues and a list of inputs used in production.

The Medical Cannabis Regulation approved by Supreme Decree No. 004-2019-SA will remain in force until the new regulation enters into force, after which it will be repealed.

We hope that this information will be of relevance to you and your company. If you require any further information, do not hesitate to contact us.

To read the Spanish version, click here.

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We hope that this information will be of relevance to you and your company. If you require any further information, do not hesitate to contact us.

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