The Spanish government approved on October 7 a royal decrete that regulates medical cannabis as “standardized preparations”, as a treatment alternative in the health system of Spain.
According to the Spanish Ministry of Health, under the new decree, doctors could prescribe medical marijuana to patients with severe epilepsy or chronic pain. They can also treat those who have cancer, multiple sclerosis spasticity, and other diseases where traditional treatments are ineffective.
Spain’s Council of Ministers – the executive branch’s decision-making body headed by Prime Minister Pedro Sánchez – authorized the decree at the country’s Ministry of Health proposal. Spain’s Congress must still vote on the proposal.
The Ministry of Health stated that “this regulation was requested by the Health and Consumer Affairs Committee of Congress of Deputies and represents a crucial step in integrating medicinal cannabis into the system of health care, assuring its use under scientific, clinical and control of health guarantees.”
According to the law, only Spanish hospital pharmacies will have access to medical cannabis. Spanish Agency for Medicines and Medical Devices will ensure that medical cannabis prescriptions meet quality, safety and dose standards.
The deed leaves the details of an upcoming government program up to various health agencies. According to the Ministry of Health, the intention of the decree is to establish a framework that can be easily adapted to new developments based upon “scientific advancements and clinical evidence.”
In addition to the scientific evidence that supports cannabis use, some countries also consider international controls and treaty obligations imposed by 1961 UN Single Convention on Narcotic Drugs.
RELATED: Rescheduling Cannabis: Will 1961 Drug Treaty Act as a Potential Wrench
Canada is the first nation in the Group of Seven to change its policy to allow dispensaries to sell cannabis to non-medical users.
Germany in Europe Cannabis laws reform in the U.S. In 2024, the cannabis plant will be reclassified as non-narcotic and allowed for home cultivation. This shift in policy didn’t change the perception. A spokesperson for the Report back to us Published Oct. 6, many German doctors are reluctant to recommend medical cannabis.
Spain could be different
The Spanish Ministry of Health states that “scientific data endorsed by organizations internationally has demonstrated the benefits of some specific clinical situations.” The Ministry of Health in Spain says that “in these cases, approved medicines may not be sufficient, so master formulations made with standardized cannabis preparations can provide an alternative therapy, under strict medical and pharmacological supervision.”
This week’s royal decree does not include a list of conditions that must be met, like most U.S. states do in their medical cannabis programs. The decree instead requires that the AEMPS establishes authorized clinical uses on the basis of scholarly monographs, and then publishes them in the National Formulary within three months.
It’s not clear if patients in Spain will have access to cannabis oil or any other forms of smokable marijuana, or whether the government plans to restrict other forms such as flower.
AEMPS is also tasked to manage a registry for standardized formulas of products that have been lab tested for THC or CBD. Products containing THC above 0.2% will be subjected to stricter regulatory standards in manufacturing, distribution and traceability.
According to the Ministry of Health, “With this regulatory change, the Government reaffirms their commitment to a more personalized, evidence-based and safe medicine. This regulation offers an alternative to those patients who do not find effective results from approved medication.”
Although the Spanish Cabinet approved the decree it doesn’t mean that the deal is done. Spanish Congress will vote on this proposal, and it could change the law.
This reform movement comes just seven months after a patient advocate group called the Spanish Observatory of Medical Cannabis, or OECM. Dissolve The organization, after fighting for a decade to improve the policies of cannabis in Canada, has now been recognized by the Canna Reporter reported.
OECM estimates that over 300,000 Spaniards self-treat medical conditions with cannabis.
On Oct. 7, the Spanish Cabinet approved a Royal Decree to regulate “standardized preparations of medical cannabis” for use as an alternative therapeutic treatment in Spain’s healthcare system.
According to the Spanish Ministry of Health, under the new decree, doctors could prescribe medical marijuana to patients with severe epilepsy or chronic pain. They can also treat those who have cancer, multiple sclerosis spasticity, and severe seizures.
Spain’s Council of Ministers – the executive branch’s decision-making body headed by Prime Minister Pedro Sánchez – authorized the decree at the country’s Ministry of Health proposal. Spain’s Congress must still vote on the proposal.
The Ministry of Health stated that “this regulation was requested by the Health and Consumer Affairs Committee of Congress of Deputies and represents a crucial step in the integration of Medical Cannabis into the Health Care System, assuring its use under scientific, medical and health control assurances.”
According to the law, only Spanish hospital pharmacies will have access to medical cannabis. Spanish Agency for Medicines and Medical Devices will ensure that medical cannabis prescriptions meet quality, safety and dose standards.
In the decree, many details of an upcoming government program are left to various agencies of health. The decree aims to create a flexible model that can be adapted to “scientific advancements and clinical evidence,” as stated by the Ministry of Health.
It is not uncommon for many countries to formulate their cannabis policy with an eye towards international control, and the obligations of 1961’s Single Convention on Narcotic Drugs, which was adopted by the United Nations.
Reclassifying Cannabis: Could 1961 Drug Treaty be a Wrench for Rescheduling Cannabis?
Canada is the first nation in the Group of Seven to change its policy to allow dispensaries to sell cannabis to non-medical users.
Germany in Europe Cannabis laws reform in the U.S. In 2024, the cannabis plant will be reclassified as non-narcotic and allowed for home cultivation. This shift in policy didn’t change the perception. A spokesperson for the Reportage Published Oct. 6, many German doctors are reluctant and seldom prescribe medical cannabis.
Spain could be different
The Spanish Ministry of Health states that “scientific data backed by international organisations has demonstrated the benefits of some specific clinical situations.” The Ministry of Health in Spain says that “in these cases, approved medicines may not be sufficient, so master formulations created from cannabis-standardized preparations can provide an alternative therapy with therapeutic potential, under strict medical supervision and pharmaceutical control.”
This week’s royal decree does not include a list of conditions that must be met, like most U.S. states do in their medical cannabis programs. The decree instead requires that the AEMPS establishes authorized clinical uses on the basis of scholarly monographs, and then publishes them in the National Formulary within three months.
It’s not clear if patients in Spain will have access to cannabis oil or any other forms of smokable marijuana, or whether the government plans to restrict other forms such as flower.
AEMPS is also tasked to manage a registry for standardized formulas of products that have been lab tested for THC or CBD. Products containing THC above 0.2% will be subjected to stricter regulatory standards in manufacturing, distribution and traceability.
The Ministry of Health stated that “this regulation reaffirms the commitment of the government to personalized medicine which is safe, effective and based on evidence.” It also offers an option for people who don’t find relief from the approved medicines.
Although the Spanish Cabinet approved the decree it doesn’t mean that the deal is done. Spanish Congress will vote on this proposal, and it could change the law.
This reform movement comes just seven months after a patient advocate group called the Spanish Observatory of Medical Cannabis, or OECM. Dissolve The organization, after fighting for a decade to improve the policies of cannabis in Canada, has now been recognized by the Canna Reporter reported.
OECM estimates that over 300,000 Spaniards self-treat medical conditions with cannabis.
Cannabis Law Resources – Poland
Browse essential legal pages on cannabis sales and cultivation in Poland. These guides will help you understand the legal requirements, such as certifications and permissions.
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Polish News Registration and Interests of Cannabis Businesses
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Permissions for Cannabis Sales in Poland
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Authorization for Importing or Manufacturing Medical Products
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Permission for Manufacturing or Importing Medical Products
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Certificate of Good Manufacturing Practices (GMP)
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Registration of Medical Products in Poland