Cannabis law and legislation in Portugal

Under the Portuguese Law, the use of cannabis for medical purposes is admissible, provided the necessary requirements and the mandatory licenses are obtained.

The Portuguese legal framework is set forth under Law no. 33/2018, of July 18th and the Decree-Law no. 8/2019 of January 15th on the use of medicines, preparations, and substances based on the cannabis plant for medicinal purposes, determining its principles and objectives, as well as the regulation and supervision of activities related to the use of the cannabis plant for medicinal purposes..

More recently, the Ministerial Order 83/2021 established a number of practical aspects regarding the authorisations to engage in activities related to the medical use of, as well as the requirements and procedures for applying and granting authorization the exercise activities of cultivation, manufacture, wholesale trade, transport, circulation, import and export of medicines, preparations and substances based on the cannabis plant. According to which the applications for the authorisation of activities related to cannabis for medical, veterinary or scientific research purposes should be submitted through INFARMED’s website, which will then request an opinion from the Intervention Service on Additive Behaviours and Addictions (SICAD).  

The considered authorizations must comprise a number of mandatory elements and information, which may vary depending on the specific scope of activity. 

Regarding the INFARMED authorisation, INFARMED will decide on the request within 90 days from the date of admission of the application.

The prescription of cannabis-based medicinal products, preparations, and substances is a special medical prescription made in accordance with a special form approved by the Ministry of Health. The prescription must identify the patient, the prescribing doctor, the medicinal product, preparation or substance, respective quantity, dosage, and mode of application. The prescription of cannabis-based medicinal products, preparations, and substances can only take place when conventional treatments are not efficient or cause relevant adverse effects and the therapeutic indication of the cannabis-based medicinal products, preparations and substances have been approved by INFARMED. Prescriptions of cannabis- based medicinal products, preparations, and substances can only be used once.

Dispensation of cannabis-based medicinal products, preparations, and substances for medical purposes can only be made in pharmacies by pharmacists upon provision of the respective prescription and verification of the purchaser’s identity.
The holder of a special prescription for cannabis-based medicinal products, preparations, and substances can hold and transport cannabis-based medicinal products, preparations, and substances for their own consumption, according to the prescription and up to the quantity prescribed.

Furthermore, under the Ministerial Order 83/2021 a number of security measures must be implemented throughout the medical cannabis production chain, such as (i) video surveillance system, (ii) intrusion detection system, (iii) permanent connection with control center; (iv) security guard on permanent duty. These obligations can be densified according to the activity pursued. 

Additionally, Ministerial Order no. 44-A/2019, of 31 January, establishes the mechanisms under which the price of medicines and preparations and substances based on the cannabis plant intended for medical purposes should be set. In general, the framework establishes that the price should be proposed by the holder of the authorisation to place the substance on the market to INFARMED, with reference to the current price on the international market. The price will then be approved or refused by INFARMED. In case of refusal, the holder of the authorisation to place the substance on the market should propose a new price.

Finally, a recent technical note regarding the Management of Cannabis Waste in the context of activities that produce cannabis for medicinal purposes was published on 8 February 2022 has been issue jointly by INFARMED and APA (the Portuguese Environmental Agency), establishing an ancillary obligation to submit all data on the waste managed to the Integrated Electronic Waste Registration System (Sistema Integrado de Registo Eletrónico de Resíduos - “SIRER”). Moreover, the cannabis plant waste must  be sent to a specific destination in accordance with the waste hierarchy principle

Producing, importing, and selling recreational hemp is prohibited in Portugal.

However, it is not considered a crime to possess plants, substances, or preparations in quantities which do not exceed that required for average individual consumption during a 10-day period.

The cultivation of hemp for industrial purposes is a lawful activity in Portugal, having first been authorised and encouraged by Community law, it was then transposed into national law by an amendment to Regulatory Decree 61/94 (establishing rules for the control of the licit market in narcotic drugs and psychotropic substances).

The Administrative Rule 14/2022, of 5 January, provides that hemp can only be cultivated outdoors (it is not possible to grow in greenhouses, nor in closed spaces); cultivation can only take place in an area of at least five hectares; transplanting of plants is not allowed; and the density of sowing cannot be less than 30kg per hectare. It is also forbidden to transport flowering plant juices off the farm (even if they can no longer be used for industrial hemp cultivation) and rules have also been established on the reuse of opened seed packages. 

As regards CBD, it is, from a legal point of view, in a grey area. In fact, in Portugal, the marketing of CBD is classified by the authorities as a prohibited activity insofar as CBD, as a substance extracted from the flowers and leaves of the cannabis plant (and not from the stalks and seeds), must be treated as a controlled substance. Consequently, the plant may only be cultivated and marketed in accordance with the rules for the cultivation and marketing of controlled substances (i.e. essentially for medicinal purposes).

In ASAE’s view, the use of cannabinoids (such as CBD, THC, cannabigerol (CBG), and cannabinol (CBN)), in food will mean that such foods are considered unauthorized novel foods, similar to plant parts and their extracts. Thus, the commercialization of foods containing these substances is not authorized.

The DGAV has also commented on this, stating that CBD has no history of consumption as a food or food ingredient in the EU prior to 1997, and it cannot be used in food as it does not meet the requirements of the Novel Foods and Food Ingredients Regulation (EU) 2015-2283. Therefore, to be placed on the market, CBD will have to undergo a risk assessment by EFSA..

There is no general prohibition on patenting cannabis- based products, according to Código da Propriedade Industrial (the Industrial Property Code Decree no. 110/2018). However, it is important to note that any commercial exploitation which is contrary to public order or morality shall not be patentable.

Pursuant to this principle, if the invention is not contrary to the public order, then it is possible to obtain a patent.

There have been no recent development in terms of legislation on cannabis.