NEWS FROM PERU AND THE WORLD
PERU: MEETING BETWEEN MEDICAL CANNABIS USERS AND REGULATORY AUTHORITIES
At the meeting held at the General Directorate of Medicines, Inputs and Drugs (Digemid), representatives of cannabis patient associations met to report on the procedure for licenses for artisanal production with associative cultivation of cannabis for medicinal and therapeutic purposes.
During the meeting, experts from the Peruvian National Police detailed the technical guidelines for the “Security Protocol” required for approval, while specialists from the General Directorate of Agricultural Development and Agroecology (DGAA) and the National Agricultural Health Service (Senasa) explained the requirements of the cultivation plan. In addition, Digemid specialists provided details on the formats and data required in the processing plan.
PERU: U.S. PHARMACOPEIA (USP) REPRESENTATIVE TRAINS DIGEMID OFFICIALS ON THE QUALITY OF MEDICAL CANNABIS
USP’s Scientific Affairs Manager for Mexico and Central America held the conference “USP’s Perspective on the Quality of Medicinal Cannabis” for DIGEMID officials. In this way, the Peruvian officials learned about the quality standards that USP has for medicinal cannabis medicines.
ARGENTINA: REGULATION OF MEDICAL CANNABIS AND INDUSTRIAL CANNABIS
Law No. 27,669, known as the “Regulatory Framework for the Development of the Medical Cannabis and Industrial Hemp Industry” in Argentina, aims to establish a national production and commercialization chain and/or for the export of the cannabis plant, its seeds and derived products destined for medicinal and industrial purposes, including scientific research.
The law is mandatory throughout Argentina and seeks to comply with international conventions on narcotic and psychotropic drugs, allowing the cultivation of cannabis exclusively for industrial and horticultural purposes.
In line with this law, the Regulatory Agency of the Hemp and Medical Cannabis Industry (ARICCAME) has been created, which is responsible for regulating various activities related to cannabis and hemp, from cultivation to commercialization, and promoting the development of productive capacities in the country.
In addition, a “One-Stop Shop for the Hemp and Medical Cannabis Industry” system is established for the efficient management of procedures and authorizations. The legislation seeks to coordinate efforts between the public and private sectors and civil society organizations in a regulated framework that benefits the health of the population and promotes the cannabis and hemp industry in Argentina.
GERMANY: CONTROLLED LEGALIZATION OF RECREATIONAL CANNABIS
A bill was passed allowing persons over 18 years of age to purchase 25 to 50 grams of cannabis per month and to cultivate three cannabis plants on their own. Acquisition would only take place through cannabis consumption and cultivation associations, to which the purchaser must be affiliated.
Consumption is prohibited on public roads during the day and always in the vicinity of basic education institutions. At the same time, the project foresees the implementation of campaigns to inform the population about the dangers and damages of THC consumption.
BRAZIL: ANVISA CLARIFIES REGULATION ON ADVERTISING OF CANNABIS PRODUCTS
The National Health Surveillance Agency (Anvisa) establishes that advertising of cannabis-derived products is not allowed in cases where Anvisa grants exceptional authorization for exclusive importation by natural persons. In addition, it is forbidden to expose such products for sale in Brazil, including advertisements on websites.
According to Resolution of the Collegiate Directorate (RDC) 96/2008, which regulates the advertising and promotion of medicines, only the advertising of medicines regulated by Anvisa in accordance with Law 6.360/1976 is allowed.
The cannabis-derived products for which the Agency exceptionally authorizes exclusive importation by natural persons, through RDC 660/2022, have not been regulated, meaning that their efficacy, quality and safety have not been evaluated by Anvisa. Importation has been authorized exclusively for personal use by natural persons. In this regard, the Agency emphasizes that advertising or other practices with the purpose of commercially promoting these products are not allowed.
ISRAEL: REFORM OF MEDICAL CANNABIS REGULATION
The Israeli Ministry of Health announced future major amendments to be made to the regulation of medical cannabis that are scheduled to come into effect in December 2023, with the aim of optimizing and reducing regulation in this field.
The main objective of the reform is to reduce the costs of medical cannabis for patients, encourage research and development in the field of medical cannabis, simplify the bureaucratic burden for patients and facilitate treatment with medical cannabis. The Ministry of Health emphasizes that this reform seeks to combine social sensitivity with public health protection and will help improve the quality of life of Israeli citizens who require medical cannabis treatment.
