Portugal’s medical cannabis regulator approves first new preparations since 2021

Via Business of Cannabis

Portugal’s cannabis regulator has approved three new cannabis preparations for its medical cannabis programme, marking the first expansion since 2021.

Since voting to legalise medical cannabis in 2018, Portugal has only seen one cannabis preparation be approved by INFARMED (Instituto Nacional de Farmacologia e Medicamentos).

Earlier this week, the regulator approved a further three preparations, in what has been described as a ‘monumental step forward for patient care in Portugal’.

What happened?

Portugal’s first, and until this week only, medical cannabis product with market authorisation was Tilray’s 18% THC and less than 1% CBD dried flower product, which was given the green light in 2021.

As Portuguese cannabis publication Cannareporter reported a year after its approval, the limited availability of products and slow progress on approving any new ones meant that supply was not meeting demand.

Speaking to the publication at the time, Paula Mota, head of the advocacy group Mothers of Cannabis Movement, said that the product did not meet the needs of many patients, especially those under the age of 18 like her daughter with refractory epilepsy.

“In addition, its prescription is only for some pathologies, namely chronic pain, nausea, spasticity, and glaucoma, which leaves out epilepsy, for example.”.

Now, a further three preparations have been approved and are expected to be made available to patients ‘in late spring’.

The new preparations 

Tilray, which operates a GMP-certified EU facility in Cantanhede, Portugal, received approval for a second preparation in the market on March 11.

This is one of two medical cannabis oils to be approved, and is reportedly ‘indicated for use in several critical areas of patient care’.

The ‘Tilray Oral Solution THC 5 CBD 20’ preparation is a CBD dominant extract (with a 1-4 ratio of CBD to THC) and is already available in other markets like Germany.

In a press release, Tilray’s Chief Strategy Officer and Head of International, Denise Faltischek, , said: “This is a monumental step forward for patient care in Portugal. With the approval of our first medical cannabis extract, we are proud to be at the forefront of medical cannabis research and accessibility and continue to demonstrate our commitment to providing innovative, safe, and effective therapeutic options to patients.

“We continue to pioneer the future of medical cannabis, furthering our mission to empower and inspire individuals to live their best lives.”

The second oral solution is from Portuguese pharmaceutical operator Ferraz Lynce, is another CBD dominant product, and will be available in four different versions.

Finally, a second flower product, Hexacan’s ‘Hexa 01 Alto THC 20%’, has been approved and will be sold in 10g packages for dry flower vaporisation.

The indications these products will be prescribed for are chronic pain associated with oncological diseases, epilepsy and the treatment of severe convulsive disorders in childhood, multiple sclerosis, nausea and vomiting caused by chemotherapy, and appetite stimulation in palliative care for patients undergoing oncological treatment or with AIDS.