PERU
DIRANDRO: NEW GUIDELINES FOR SAFETY PROTOCOL
On January 13, Directive No. 002-2024-IN (“Technical guidelines for the verification and issuance of the certificate of compliance with safety devices for the development of activities with cannabis and its derivatives, regulated for medicinal and therapeutic use”) was published.
This directive complies with the provisions of Article 31 of the “Regulation that regulates the medicinal and therapeutic use of Cannabis and its derivatives”. The Regulation provides that, in order to obtain licenses for the importation, commercialization, research, production or artisanal production of cannabis and its derivatives, the administered party must first obtain the “Certificate of compliance with safety devices for the development of activities with cannabis and its derivatives, regulated for medicinal and therapeutic use”, issued by DIRANDRO.
The Certificate is obtained after an on-site verification by DIRANDRO of compliance with the implementation of security devices in the establishment of the administered, to ensure that cannabis and its derivatives, and the finished product, which would be authorized to obtain or produce with the respective licenses, are not diverted for illicit uses. After the issuance of the Certificate, DIRANDRO may continuously monitor compliance with these security guidelines.
In this sense, the Guidelines established in this new Directive consist of the specific security measures, for each type of activity, that must be taken by those who wish to obtain licenses for the importation, commercialization, research, production or artisanal production of cannabis and its derivatives.
Among others, the security measures contained in the Guidelines are:
It should be added that this Directive replaces Directive No. 006-2019-IN (“Technical guidelines with the conditions and criteria for the approval of safety protocols on the medicinal and therapeutic use of Cannabis and its derivatives”).
BILL ON THE INDUSTRIAL USE OF HEMP
The substitute text of the Bill on the Agricultural Development of Hemp for its Industrial Use, agreed upon by the Agrarian Commission and the Production Commission, is currently being debated in the Plenary Session of the Congress of the Republic of Peru.
This bill seeks to establish the legal framework for the production, supervision and commercialization of hemp for industrial use. In this way, the production of hemp for use in the manufacture of food, cosmetic, textile and construction products would be allowed through a license from Midagri, valid for 5 years. The essential requirement for the authorization is that the hemp must not contain a level of more than 1% of THC, the psychoactive component of cannabis.
THE UN: WORLD DRUG REPORT 2023
United Nations Office on Drugs and Crime (UNODC) published the “World Drug Report 2023”. As an integral part of the Report UNODC published a section on global trends in the regulation of medical cannabis.
Three regulatory trends were identified with respect to restricting access:
Three regulatory trends were also identified with respect to the control of the components of medical cannabis products that States allow to be consumed for medical purposes:
Finally, UNODC identified 4 regulatory trends on permits for cultivation and production of medical cannabis and its derivatives:
It is worth noting that the UNODC affirmed the existence of conclusive evidence on the effectiveness of medical cannabis and its derivatives to treat chronic pain in adults, nausea and vomiting induced by chemotherapy treatment, mitigation of spasms generated by sclerosis and epilepsy.
AUSTRALIA: NEW GUIDELINES FOR MEDICAL CANNABIS ADVERTISING
The Therapeutic Goods Administration (TGA) of Australia published the new version of the guide for advertising medical cannabis, which specifies the application of the Therapeutic Goods Act to the advertising of medical cannabis products.
This guidance defines the type of information disclosed and the context of the disclosure to be considered advertising. For example, among others, the TGA considers medical cannabis to be advertised if the producer or marketer publishes on its own website links to third party websites where medical cannabis is promoted.
The TGA clarifies that advertising related to medical cannabis and its derivatives is prohibited, as it is a pharmaceutical product with sale subject to a medical prescription. Thus, its advertising is only allowed when it is directed to health professionals.
BRAZIL: NEWS ON THE REGULATION OF THE SUPPLY OF MEDICAL CANNABIS IN THE STATES OF SÃO PAULO AND RIO DE JAINERO
At the end of last December, the Government of the State of São Paulo published Decree No. 68.233, which regulates Law No. 17618 of January 31, 2023.
This regulation establishes the State Policy for the free supply of medicines formulated from plant derivatives based on CBD, on an exceptional basis by the Executive Power in state and private public health units in agreement with the Unified Health System – SUS, within the scope of the State of São Paulo.
In the same sense, a few weeks earlier, Law No. 10201 was published, approved by the Legislative Assembly of the State of Rio de Janeiro, which provided for the free supply of CBD-based medicines to patients in a proven situation of poverty. This supply will be carried out by public health units that have an agreement with the Unified Health System – SUS, in the State of Rio de Janeiro.
In Brazil, more and more member states of the Federation are regulating the free supply of medical cannabis in their jurisdictions, through the Unified Health System, according to the requirements established by ANVISA in Collegiate Directorate Resolution No. 327, of December 9, 2019.
UKRAINE: LEGALIZATION OF MEDICAL CANNABIS
At the end of December 2023, the Ukrainian Parliament adopted Law No. 7457 regulating the circulation of cannabis for medicinal, industrial and scientific purposes.
The Law provides for the granting of licenses for the cultivation, import and export, production, storage and research of medical cannabis. This norm establishes that the security measures in the establishments that obtain the license will be, among others, the implementation of video surveillance; the free access of the National Police to the establishment; the electronic identification of each batch of products, supplies, etc., which will be registered in a unique electronic information system.
The Ukrainian Ministry of Health has 3 months to approve the list of diseases that can be treated with medical cannabis products.
