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Portugal’s first medical cannabis preparation approved for sale

2024-03-28
Since Portugal voted to legalize medical cannabis in 2018, only one cannabis preparation has been approved by the Portuguese regulatory agency INFARMED (Instituto Nacional de Farmacologia e Medicamentos).
The regulator's move to approve three cannabis preparations earlier last week was hailed as "a milestone in the development of medical cannabis supply and patient care in Portugal".

In fact, until this week, Portugal’s first medical cannabis product to receive market authorization was also Tilray’s 18% THC and less than 1% CBD dried flower product, but this product has been approved for marketing in 2021.
As Portuguese cannabis publication Cannareporter reported a year after Tilray's product was approved, product availability is limited and new product approvals are very slow, indicating that product supply is not meeting patient demand.

Many people in the industry still remember that Paula Mota, the head of the Portuguese cannabis advocacy organization "Cannabis Mothers Movement", said in an interview with Cannareporter that the product was far from meeting the needs of patients, especially those with refractory conditions like hers. Patients under 18 years old such as my daughter with epilepsy.
The product is reportedly prescribed only for certain conditions, such as chronic pain, nausea, spasticity and glaucoma, excluding epilepsy. Now, three new formulations have been approved and are expected to be available to patients in "late spring."
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Tilray, which has an EU GMP-certified factory in Cantanhede, Portugal, received approval for its second medical cannabis formulation on March 11.
One of two medical cannabis oils approved this time, it is reported to be “suitable for use in several key areas of patient care.” This product is an oral solution preparation, Tilray oral liquid, CBD 20% THC 5% (that is, the ratio of CBD to THC is 4:1), with CBD as the main ingredient. It is currently on the market in Germany and other countries.
Denise Faltischek, chief strategy officer and director of international operations at Tilray, said in its press release: "This is a landmark step forward for patient care in Portugal. With the approval of our first medical cannabis extract formulation, we We are extremely proud to be at the forefront of medical cannabis research and accessibility and continue to demonstrate our commitment to providing patients with innovative, safe and effective treatment options. We will continue to pioneer the future of medical cannabis and further our mission to empower and inspire Patients live their best lives.”
It is understood that the indications for the approved medical cannabis products include: chronic pain related to tumor diseases, epilepsy and severe convulsive disorders in children, multiple sclerosis, chemotherapy-induced nausea and vomiting, as well as tumor treatment and cancer patients Appetite improvement during treatment, etc., and AIDS.
 
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