The legal framework for the use of cannabis-based medicines for medicinal purposes was established on July 18 2018 (Law no. 33/2018) and was regulated on January 15, 2019 (Decree-Law no. 8/2019). However, it wasn't until April 15 2021 that Ordinance 83/2021 was finally published, defining the requirements and procedures for granting authorisations to carry out activities related to the cultivation, manufacture, wholesale trade, transport, circulation, import and export of medicines, preparations and substances based on the cannabis plant.
This legislation aims to ensure that all preparations made available to citizens meet the requirements regarding product quality and safety, with the aim of safeguarding public health and minimising the misuse of medicines or other cannabis-based preparations. This legislation has laid the foundations for an economic agent to legally cultivate, manufacture, wholesale, import, export and transit cannabis plants and cannabis products.
The two main ingredients of cannabis are tetrahydrocannabinol ("THC"), which is the psychoactive substance in cannabis, and cannabidiol ("CBD"), a chemical found in the cannabis sativa plant, which is a non-psychoactive compound that has gained popularity due to its alleged therapeutic properties. The legality of CBD is often linked to its tetrahydrocannabinol ("THC") content. Portugal, like most EU member states, allows CBD to be sold, with the restriction that CBD products contain less than 0.2 per cent THC.
Since 2018, Portugal has seen a substantial increase in licence applications for the cultivation and manufacture of cannabis for medicinal purposes from INFARMED, the regulatory body for this activity.
From the support we provide to our clients, we realise that the successes and challenges faced by companies in the production of medicinal cannabis include the importance of collaboration with regulatory authorities and commitment to high standards of quality and safety.
The licensing process for companies interested in growing cannabis in the country is governed by a series of specific regulations and requirements, designed to ensure compliance with local and international laws and promote product safety and quality.
The Commercial and Corporate Law Department at Belzuz Advogados has extensive experience in licensing processes for the cultivation and manufacture of cannabis for medicinal purposes, accompanying its clients at every stage of the process.
Belzuz Abogados SLP
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