Tilray gets Infarmed approval for cannabis flowers with 18% THC

A Tilray has just approved its first “cannabis-based substance or preparation” in Portugal, by obtaining an ACM (Marketing Authorization) from the INFARMED, IP for dried flowers with 18% THC and less than 1% CBD. This is the second cannabis-based product to be approved in Portugal — the first was Sativex — and it sees the light of day after more than a year of waiting. The price has not yet been approved and it is not yet known whether it will be reimbursed.

The news was published this morning by Agência Lusa and replicated by various media, such as Diário de Notícias, Public, Observer, Sic News or the frog 24, but none of them clarifies which substance is approved or for which pathologies it is indicated. Tilray's press release does not mention which product or substance received the ACM, but information about the approved product is already available on the Infarmed website.

Tilray's facilities in Cantanhede, in the district of Coimbra, Portugal

To Cannareporter, a source from Infarmed assured that the price is a mandatory condition for the product to be available for prescription and that has not yet been defined. In addition, Infarmed states that it must also be the company that owns the ACM to request the reimbursement. Tilray confirmed to Cannareporter that the price is not yet approved, so it is not yet known whether or not it will be reimbursed by the State.

Speaking to Cannareporter, Rita Barata, Marketing Director in Europe and Country Manager for Tilray in the Iberian Peninsula, stated that he could not go into further details beyond the press release and that the price of this product is “awaitingr evaluation and approval of Infarmed”. Regarding the availability of new products in the Portuguese market, Rita Barata says that “we hope in the near future to submit new requests for ACM to Infarmed”.

What is the difference between a drug and a cannabis-based substance or preparation?

Tilray states in a statement that this is “the first and only preparation or substance based on the cannabis plant for medicinal purposes allowed in our country”, despite the fact that Sativex already exists in Portugal, authorized in Portugal in 2012, and available in hospital upon request for special authorization.

Sativex, which has a 1:1 ratio of THC and CBD, is considered a drug and obtained AIM from Infarmed in 2012

If there was already an Infarmed-approved cannabis-based drug, how is it that Tilray's product is the “one and only”? This is explained by the fact that Tilray flowers now approved by Infarmed fall into the category of “cannabis-based substances and preparations”, which require an ACM – Marketing Authorization. A source from Infarmed explained to Cannareporter that the ACM was “a way to simplify the entry of medicinal cannabis products into the Portuguese market, as the AIM – Marketing Authorization – granted to medicines, require prior clinical trials to prove their effectiveness” .

It is, therefore, in the category of Medicines that Sativex falls, and GW Pharmaceuticals, holder of the MA, presented the respective clinical trials to obtain the approval of Infarmed.

Tilray's product, falling into the category of “substances and preparations based on the cannabis plant”, is effectively the first and only one to obtain an ACM from Infarmed, as it did not require clinical trials to prove its effectiveness.

Infarmed approval is for cannabis flower with 18% THC and less than 1% CBD

In a site search infomed, from Infarmed, it is now possible to find the two cannabis-based products approved by the Medicines Authority. Sativex and “Tilray Dry Flower THC 18”, flowers with 18% delta-9-tetrahydrocannabinol (THC) and less than 1% cannabidiol (CBD).

No information document for health professionals On the Infarmed website you can read that this medicine is only indicated for people aged 25 years and over and that it should not be prescribed to children or persons under 18 years of age.

Furthermore, the document states that “this product is indicated only in cases where conventional treatments have not produced the expected effects or cause relevant adverse effects. The specific composition determines how cannabis works and what adverse effects it can cause.”

The Infarmed website also provides the instructions for use so that healthcare professionals can prescribe the “inflorescences with a high content of delta-9-tetrahydrocannabinol (THC >> CBD)” in the following cases:

• Nausea and vomiting (from chemotherapy, radiation therapy and combination therapy for HIV and hepatitis C medication)
• Stimulation of appetite in palliative care of patients undergoing cancer treatments or with AIDS;
• Therapy-resistant glaucoma Inflorescences with a high content of delta-9-tetrahydrocannabinol (THC) or with a balanced content of delta-9-tetrahydrocannabinol and cannabidiol (THC >> CBD or THC ≈ CBD)
• Chronic pain (associated with oncological or nervous system diseases such as neuropathic pain caused by nerve damage, phantom limb pain, trigeminal neuralgia or after herpes zoster)
• Gilles de la Tourette syndrome
• Spasticity associated with multiple sclerosis or spinal cord injuries;

O Valid identity document also warns that, given its concentration, Tilray Flor Seca THC 18 is not indicated for Epilepsy and the treatment of severe convulsive disorders in childhood, such as Dravet and Lennox Gastaut syndromes, since inflorescences with a high content of cannabidiol (CBD) and low delta-9-tetrahydrocannabinol (THC).

Tilray recommends users that Flor Seca THC18 is “administered with a medical cannabis vaporizer classified as a medical device (eg Volcano Medic or Mighty Medic)” and warns of a long list of interactions with other medications and undesirable effects.

Tilray guarantees that more products are on the way
Tilray is still “planning, in the near future, to make other products accessible to patients in Portugal”, said Rita Barata, Tilray's General Manager, in a statement sent to the Lusa agency.

According to the official, the demands of patients are increasing "and Tilray's mission is to provide the safest and best quality products that meet their needs as much as possible".

The production unit in Cantanhede has all the necessary certifications to locally cultivate and produce cannabis-based preparations and substances for medicinal purposes and export finished products with certification of Good Production Practices throughout the European Union and other international markets that have the use of the regulated plant.

Sascha Mielcarek, the company's general manager in Europe, points out that Infarmed's authorization “confirms that Tilray's medical cannabis products meet the highest national and international standards”.

Tilray is one of the world's largest companies dedicated to the research, cultivation, production and distribution of medical cannabis, with its products available in 16 countries around the world. Its main facilities are in Cantanhede, in the district of Coimbra, but the company also cultivates in Herdade do Esporão, in Alentejo, in addition to to import large quantities from Uruguay.

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Laura Ramos

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With a degree in Journalism from the University of Coimbra, Laura Ramos has a postgraduate degree in Photography and has been a Journalist since 1998. Winner of the Business of Cannabis Awards in the category "Journalist of the Year 2024", Laura was a correspondent for Jornal de Notícias in Rome, Italy, and Press Officer in the Office of the Minister of Education of the 21st Portuguese Government. She has an international certification in Permaculture (PDC) and created the street-art photography archive “Say What? Lisbon” @saywhatlisbon. Co-founder and Editor of CannaReporter® and coordinator of PTMC - Portugal Medical Cannabis, Laura directed the documentary “Pacientes” and was part of the steering group of the first Postgraduate Course in GxP's for Medicinal Cannabis in Portugal, in partnership with the Military Laboratory and the Faculty of Pharmacy of the University of Lisbon.

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