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“Is CBD legal?” We asked Infarmed 6 cannabis questions

Cannabis-based medicines in Portugal are practically non-existent, being approved in our country only Sativex, indicated in Multiple Sclerosis, which costs around 500 euros and is not, however, marketed or reimbursed. The status of Cannabidiol (CBD) has also raised many doubts among patients who seek to use it for […]

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Cannabis-based medicines in Portugal are practically non-existent, being approved in our country only Sativex, indicated in Multiple Sclerosis, which costs around 500 euros and is not, however, marketed or reimbursed.

The status of Cannabidiol (CBD) has also raised many doubts among patients who seek to use it for therapeutic purposes, so Cannapress asked the infarmed, last February, by email, to answer some questions about medical cannabis.

Since the answers sent were not, in our opinion, sufficiently enlightening, we decided not to publish them immediately and asked for a face-to-face interview with an Infarmed official to deepen the matter, because we would like to film the interview to include in the documentary "Patients — Waiting for the Law".

Sativex, by GW Pharmaceuticals, is the only cannabinoid-based drug authorized in Portugal, but it is subject to a special prescription and is not marketed. PHOTO: DR

Medical cannabis has, however, gotten a lot of ink out there and several articles try to discern exactly what the legal status of CBD is or how many units of Sativex have been sold in Portugal.

The information transmitted by the media continues, however, not to be sufficiently clear, having led Infarmed to issue a denial to a article by journalist Fernanda Câncio, which precisely questioned the legality of the CBD, in Diário de Notícias.

Cannapress therefore continues to wait for an in-person interview to be scheduled to better clarify all these issues, which are of vital importance for families who are currently facing difficulties in accessing cannabinoid therapies. For now, here are the six questions we asked Infarmed and the respective answers, sent by a press officer on February 15, 2018. 

1. Which cannabis-based medicines are currently available in Portugal and in which pharmacies?
In Portugal, there is the drug Sativex.

2. How many Sativex units are/or have been sold in our country?
It is a drug subject to a special prescription with the pharmacotherapeutic classification 2.10 Analgesics and antipyretics, with marketing authorization (AIM) since June 19, 2012. This drug, although approved, has never been marketed.

3. How is it prescribed and who can prescribe Sativex at this time?
Despite having a marketing authorization in Portugal, Sativex medicine can only be purchased by health institutions by submitting an application for an Authorization for Exceptional Use (AUE), whose requirements and obligations are set out in the Deliberation 1546/2015, of June 18th.

4. What is the current price of Sativex? Is it funded by the state?
You can find this and other information about this and other medicines available in Portugal at the Infomed Database, available on the Infarmed website.

5. Taking into account the recent position of the WHO, what is the current legal status of CBD (cannabidiol) in Portugal?
The chemical substance Cannabidiol (CBD) is not classified as a controlled substance in the United Nations tables, and is not included in the tables annexed to Decree-Law No. 15/93, of 22 January.

6. What are the requirements and applicable legislation for a national producer to be able to plant medical cannabis in Portugal?
National legislation in the field of controlled substances reinforces and complements the measures provided for in the 1961 Convention on Narcotic Drugs, modified by the 1972 Protocol. The legislation that regulates these matters is Decree-Law No. 15/93, of 22 January and Regulatory Decree no. 61/94, of 12 October.
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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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6 years ago

Laura Ramos, thank you ever so for you post.Much thanks again.

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