PERU
DIGEMID CANNABIS PRODUCTS WITHOUT SANITARY REGISTRATION
DIGEMID supervised the internet marketing of natural products derived from cannabis for health use that do not have sanitary registration.
Through Alerts 9-2024 and 27-2024, the Digemid reported on the verification of complaints received related to the sale and marketing of the products Sublingual CBD oils Harmony Premium, Neuro and Vital Green confirming that they lack sanitary registration.
The marketing of cannabis-derived products is subject to the provisions of the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Medical Devices, approved by Supreme Decree No. 016-2011-SA; therefore, their marketing without sanitary registration is prohibited.
AMERICA
COLOMBIA: CONSTITUTIONAL COURT ORDERS STATE TO PROVIDE MEDICAL CANNABIS
The Constitutional Court of Colombia protected the rights to life with dignity and health, and ordered the health entity to authorize and supply cannabis-based medicines (master formulas) for the treatment of chronic pain and insomnia. It urged the Ministry of Health and Social Protection and the Institute for the Evaluation of Health Technologies to, in a coordinated manner and within the framework of their legal and regulatory competencies, guarantee users access to the use of cannabis and its derivatives under the terms of the regulations in force.
The Constitutional Court pointed out that the search for an optimal state of health is inherent to a dignified life. It affirmed that the lack of supply of the cannabis-based medicine – prescribed for medical reasons in accordance with the regulations – did not allow the plaintiffs to mitigate the pain they suffered and with which they lived daily and, therefore, they could not enjoy an adequate quality of life. It considered that the health entity, by denying them the supply of the prescribed cannabis medicine, had violated their right to a dignified life.
In essence, the Constitutional Court stated that denying the provision of a health service financed with public resources generates an administrative barrier for the patient that violates the fundamental right to health.
ARGENTINA: THE NATIONAL INSTITUTE OF SEEDS (INASE) MAKES CLARIFICATIONS ON REGISTRATIONS AND TRANSFERS
The technical team of INASE made a series of clarifications on the activity related to Cannabis seeds:
Inscriptions:
For cannabis varieties with more than 1% THC, a certificate from the Ministry of Health is required to register them in the National Register of Cultivars.
Hemp” varieties with less than 1% THC must meet the common criteria for registration and commercialization.
Projects approved under Law No. 27,350 must use varieties registered in the National Register of Cultivars or regularize the status of the material used.
Transfers:
INASE does not grant transfer authorizations for cannabis products.
The transfer of seedlings, seeds and cuttings of registered varieties with the corresponding identification label is allowed.
Those registered in specific categories of the National Registry of Trade and Control of Seeds may transfer non-registered varieties within their declared establishments.
Varieties not entered in the National Register of Cultivars may not be marketed and all declarations to INASE must be made on oath.
EUROPE
EUROPEAN UNION: CITIZENS’ INITIATIVE FOR THE REGULATION OF MEDICAL CANNABIS
The European Commission registered the citizens’ initiative entitled “European Cannabis Initiative”. This citizens’ initiative proposes that the European Commission by means of legal acts of the European Union does the following:
(a) promote access to medical cannabis on the basis of scientific data and patients’ experiences, and allow patients to transport cannabis and any of its derivatives prescribed for therapeutic uses throughout the European Union, in order to ensure the full enjoyment of the right to health;
(b) allocate the necessary resources to research cannabis for therapeutic use.
Now that the citizens’ initiative has been duly registered, in order for the European Commission to take action on this initiative and for the European Parliament to examine it, it will be necessary to collect one million signatures from citizens of at least seven European Union Member States, both physically and online.
GERMANY: BUNDESTAG AND BUNDESRAT APPROVE BILL FOR CANNABIS LEGALIZATION
In February the Bundestag (Lower House of the German Parliament) approved a bill submitted by the Federal Government that includes several measures, including:
The authorization of adult consumption and possession of cannabis
The possibility to consume in public outside the hours between 7:00 am and 8:00 pm.
The legalization of self-cultivation up to a maximum of 3 plants.
The provision of recreational cannabis only through “cultivation associations”.
Removal of cannabis from the list of prohibited narcotics.
This leads to its decriminalization and benign retroactivity, as well as facilitating the prescription of cannabis-derived pharmaceuticals.
Then, at the end of March, the Bundesrat (Upper House of the German Parliament) passed the Law on the Controlled Use of Cannabis without convening the mediation committee for review. As a result, the Controlled Use of Cannabis Act will enter into force on April 1, 2024.
With this, Germany will become the third country in the European Union to allow the recreational use of cannabis, after Luxembourg and Malta.
SPAIN: DRAFT DECREE FOR MAGISTRAL PREPARATIONS OF MEDICAL CANNABIS
The Spanish Ministry of Health is preparing the “Draft Royal Decree establishing the conditions for the elaboration and dispensation of master formulas based on standardized cannabis preparations”.
Although certain cannabis-derived products have already been authorized in Spain to treat epilepsy, the purpose of this regulation is to facilitate wider access to cannabis-based medicines in the form of magistral formulas, made from standardized preparations.
Additionally, it seeks to regulate the conditions of labeling, conservation, quality control, prescription, dispensation, and information provided to health professionals and patients, with respect to this type of medicine. The regulation is limited to allowing the production of magistral formulas (oils) in order to monitor and guarantee the quality and safety of the drugs.
ASIA
PAKISTAN: CANNABIS INDUSTRY LAW PUBLISHED
The Government of Pakistan published the Ordinance regulating the cultivation of the cannabis plant, its extraction, refinement, manufacture, and marketing of plant derivatives for medicinal and industrial use.
This regulation creates the Cannabis Control and Regulatory Authority (CCRA) and establishes the framework for the issuance of licenses for the cultivation, production, manufacture and sale of industrial or medicinal products derived from cannabis.
It also regulates labeling conditions and good manufacturing practices. The details of the regulation will be published in the respective regulations. The implementation of the regulation will be established and enforced with the assistance of the Drug Regulatory Authority of Pakistan (DRAP).
Pakistan would be the second country in Asia, after Thailand, to regulate cannabis for medicinal and industrial use.
