International
Spain approves Royal Decree to regulate the medicinal use of cannabis in magistral formulations
The Spanish Council of Ministers approved a new Royal Decree regulating the medicinal use of standardized cannabis preparations intended for mastermind formulation. The regulation, announced today by the Spanish Ministry of Health, aims to offer a safe therapeutic alternative, under medical and pharmaceutical supervision.
The Spanish government today formally approved a law that will allow the integration of medicinal cannabis use through master formulas constructed from standardized preparations. This legislative step was adopted at the request of the Ministry of Health and after being reviewed by the Health and Consumer Affairs Committee of the Congress of Deputies.
The new regulation does not categorically limit the medical conditions eligible for the use of magistral formulas, and delegates to the Spanish Agency for Medicines and Health Products (AEMPS) the definition of clinical indications, dosages and specific conditions, which should be published within the next three months.
According to the decree, only specialist physicians may prescribe these formulas, and their preparation and dispensing will be restricted to authorized hospital pharmacy services. This strict control reinforces the government's intention to ensure the safety, traceability, and quality of substances used for medicinal purposes. However, the question remains whether the government is opting for an overly cautious approach.
With the approved Decree, a national public registry is also created for all standardized preparations used, with strict requirements regarding composition (percentages of THC and/or CBD), manufacturing quality, traceability, and auditing of the entire supply chain. Clinical monitoring will be a shared responsibility between the prescribing physician and the hospital pharmacy service, with regular assessments of efficacy and potential adverse effects.
In regions with geographical challenges or vulnerable health conditions, autonomous communities may establish exceptional non-face-to-face dispensing mechanisms to guarantee access to treatment, according to the statement. issued by the Ministry of Health.
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[Disclaimer: Please note that this text was originally written in Portuguese and is translated into English and other languages using an automatic translator. Some words may differ from the original and typos or errors may occur in other languages.]____________________________________________________________________________________________________
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I am one of the directors of CannaReporter, which I founded together with Laura Ramos. I am from the unique Island of Madeira, where I currently reside. While I was in Lisbon at FCUL studying Physical Engineering, I became involved in the national hemp and cannabis scene and participated in several associations, some of which I am still a member of. I follow the global industry and especially legislative advances regarding the different uses of cannabis.
I can be contacted by email at joao.costa@cannareporter.eu
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