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Cannabis Country Report Portugal – How to get a license?

February 22, 2022 | Category : Country Reports | Posted By : Deon Maas

This information serves as an introduction to potential cannabis growers in Portugal. This information is relevant to all growers. The information was correct at the time of publication.

Cannabis Licences in Portugal

How it is right now 

Portugal has a great climate and location for cannabis grow and export. Outdoor cannabis grows well in Portugal and can be produced at a lower cost than other European countries 

It’s decriminalised but must be prescribed by a doctor. 

Portugal’s current cannabis laws are regarded as among the most progressive in the world. In 2001, the government decriminalised personal cannabis use, focusing on treatment rather than punishment. As such, overall numbers of drug users in the country have gone down. However, it wasn’t until 2018 that medicinal cannabis was legalised. 

Joao Goulao, Portugal’s national drugs coordinator, is largely credited with pushing the changes through. 

CBD is legal for medicinal purposes. Industrial hemp production is legal in Portugal. To grow hemp companies must apply for a permit from Portugal’s Ministry of Agriculture. Production is heavily regulated and farmers are subject to inspections throughout the year. In order to ease and clarify legislation, Ordinance 83/2021 was passed on 5 January 2022. Through the amendment, cultivation of hemp for industrial purposes is differentiated from cultivation of the cannabis plant for other reasons. The new order only allows hemp to be grown outdoors, and prohibits growing plants in greenhouses or transplanting them. Transporting flowers, whether they contain seeds or not, isn’t allowed either. The minimum production area has been set at half a hectare, shutting out some small farmers. 

All drugs will require a license from Infarmed I.P. Infarmed I.P. is an agency under the Portuguese Health Ministry, responsible for the regulation, control and evaluation of medicines and health products for the protection of public health.  

As of June 2020 Portugal is working on draft legislation for the legalisation of cannabis for non-medical use. The current decriminalisation laws include cannabis with all other drugs like heroin and cocaine. The first step will be to remove cannabis from this list and make separate laws for it. Two parties have each presented their own draft laws to be voted on. The Left Bloc party is proposing State control of the entire process whereas the Liberal Initiative proposes little to no State control. What they do agree on is that there should be a limit on how much can be bought at any time, that places where you can smoke should be limited (not on public transport, not at work, not near children), health warnings and government control of dosages high in THC. This proposal has subsequently expired with the end of the parliamentary session in December 2021 and will have to be reintroduced at the next legislative session. The process of the legalisation of cannabis for adult use in Portugal is therefore lagging behind several other European countries. 

Infarmed I.P. is the competent entity at the national level to establish conditions and grant authorizations for the activities of cultivation, production, manufacturing, employment, trade, distribution, import, export, transit, transport and detention by any title. Additionally, they grant authorizations for the use of plants, substances and preparations. All is included in tables I to IV annexed to Decree-Law No. 15/93, of January 22 2021, within the strict limits of the country’s needs, giving precedence to medical interests, veterinarian, scientific and didactic, according to Decree-Law No. 15/93, of January 22nd , and Regulatory Decree No. 61/94, of October 12th.  

Ordinance 83/2021 was issued on the 15th of April to clarify several steps in the licensing process, clarify the security requirements and include a police inspection in the licensing process to put security in place to conform to the ordinance. 

  • Applications for authorization to carry out the activities of cultivation, manufacturing, wholesale trade, import, export, transport and circulation of medicines, preparations and substances based on the cannabis plant for medicinal, medical, veterinary and scientific research purposes must be submitted by electronic means. 
  • Access the “Pedidos de licenciamento” (Licensing Requests page (forms and drafts)), where the necessary forms and drafts are available for the submission of licensing requests. 
  • Access the ”Portal Licenciamento” (Licensing Portal) to submit licensing requests, consult and monitor their status, make payments, respond to requests for elements, receive decisions and authorizations, permits or certificates, referring to pharmacies, entities in the distribution circuit wholesale of drugs, medical devices and active substances, manufacturing of medical devices, drug intermediation activity and direct purchase of drugs by public and private pharmaceutical services. 
  • All licenses require compliance with the Good Agricultural Guidelines, Good Manufacturing Practises and Good Distribution Practises 
  • For manufacturing and wholesale activities, an authorization and a certificate of Good Practices of a community model are issued in the European EudraGMDP making them available to the general public. 
  • Each Import, Export and Transit operation depends on the issuance of the respective Official Import, Export and Transit Certificate, and for this purpose, the respective application and fee payment guide must be presented 
  • Applicants must submit annually during September, an application for an EUA for a medicinal product considered to be of well-recognized clinical benefit 

The licensing system 

  • There is a pre-license/provisional license system 
  • Licences may be obtained for: 
    Cultivation – €3,000 
    Manufacture – €3,000 
    Wholesale trade – €1,000 
    Import – €1,200 
    Export – €1,200 
    Transit – €1,000 
  • The license holder is not authorised to use these medicines or substances themselves 

Procedure 

  • Applications are submitted to Infarmed I.P. through their website page 
  • Each of the activities has to be applied for individually 
  • Infarmed I.P. will assess the suitability of the applicant to a specific need 
  • If the applicant meets the requirements and supporting documents are sufficient, Infarmed I.P. will issue the “Decisão de Aptidão” (pre-license)
  • From the date of communication, applicants will have six months to ask Infarmed I.P. to inspect the facilities where the activity in question will be performed 
  • Once Infarmed I.P. has carried out a “Vistoria” (licensing granting inspection) and confirmed that the premises meet the legal and regulatory requirements necessary to engage in the activity under the terms set out in the application submitted, it will issue the corresponding authorisation. If anomalies or divergences are detected in the facilities during the inspection, the applicant will be notified by Infarmed I.P. and must remedy them within a reasonable time. Failing this, final authorisation will not be granted 
  • Once the Infarmed I.P. inspection has been passed a police inspection will be carried out 
  • The applicant may begin its activity only once final authorisation has been granted 

Over and above the mentioned requirements, the following information may also be required by Infarmed I.P.

  • Information on the investment and development of the project 
  • Identification and address of grower 
  • Information on the facilities to be used 
  • Quantity and designation of plants that will be grown 
  • Place where product will be stored 
  • The quantity of the product as well as its application and destination 
  • Details of the technical officer and the security officer of the facility  
  • A description of security measures to be implemented 

How long does the process take? 

Infarmed I.P. will issue a decision on the documentary suitability of a properly completed application approximately 90 to 150 days from the submission date. 

Then, work on the implementation, construction or adaptation of the facilities for the activity in question will be carried out prior to Infarmed I.P.‘s subsequent inspection. The duration of this phase will vary depending on how quickly the applicant can work. The six-month maximum application period, within which the applicant can request an inspection, may usually be extended only once 

If Infarmed I.P.‘s inspection confirms that there is no need to make amendments or corrections to the facilities and once the facility has passed the police inspection, the final authorisation to engage in the activity is issued within approximately 45 days. 

Can the license be transferred? 

Licenses are non-transferable and cannot be assigned to or used by any other person for any purpose. However, it is possible to transfer the shareholdings representing the capital of a legal entity that is or will be the license holder.  

Each specific authorisation will be valid only for the period set out in the applicable order. This period cannot exceed one year, but the authorisation can be renewed or maintained for additional periods of one year. 

The medical cannabis market is very strictly controlled and strongly regulated. 

All growing happens in the Alentejo region where there are warm days and cool night, plenty of sunlight and good soil conditions. Temperatures range from 5°C to 33°C. 

Some background on Portugal

Longform name: Portuguese Republic/Republica Portuguesa 
Legislation: Semi-presidential republic
Ruling party:  Socialist Party
Currency: Euro

History

Following the Portuguese seizure of Goa in 1510, the Portuguese became familiar with the cannabis customs and trade in India. Garcia da Orta, a botanist and doctor, wrote about the uses of cannabis in his 1534 work Colloquies on the Simples and Drugs and Medicinal Matters of India and of a Few Fruits. Fifteen years later Cristobal Acosta produced the work A Tract about the Drugs and Medicines of the East Indies, outlining recipes for bhang. Cannabis was introduced to Brazil by the Portuguese colonists in the early 1800s. Their intent may have been to cultivate hemp fiber, but the enslaved Africans the Portuguese displaced from the west coast of Africa were familiar with cannabis and used it psychoactively, leading the Municipal Council of Rio de Janeiro in 1830 to prohibit bringing cannabis into the city, and punishing its use by any slave. Portugal has an illustrious history of hemp cultivation. Its people have been using the plant to create ropes and sails for centuries, which may have contributed to their reputation as great seafarers. 

Geography

Geographical Location:Southwestern Europe, bordering the North Atlantic Ocean, west of Spain 
Borders:1,224 km 
Coastline: 1793 km
Terrain:The west-flowing Tagus River divides the country: the north is mountainous toward the interior, while the south is characterized by rolling plains 

Weather

Weather:Cool and rainy in north, warmer and drier in south 

Economy

Industries:Fish, forests, iron ore, copper, zinc, tin, tungsten, silver, gold, uranium, marble, clay, gypsum, salt, arable land, hydropower 
Median Age:44.6 years 
Population growth:-0.23% 
Urbanization: 66.8%  
HIV/AIDS prevalence:0.5%
Youth unemployment: 18.3% 
GDP growth rate:  2.24%
Inflation rate: 0.3% 
Industrial production growth:3.5% 
Unemployment:6.55% 
Population below the poverty line:17.2% 
Export partners:Spain, France, Germany, United Kingdom, and United States 
Airports with paved runways: 43 
Airports with unpaved runways: 21 
Agricultural products:milk, tomatoes, olives, grapes, maize, potatoes, pork, apples, oranges, poultry 

Environmental Issues

Soil erosion; air pollution caused by industrial and vehicle emissions; water pollution, especially in urban centers and coastal areas.

https://www.infarmed.pt/web/infarmed/substancias-controladas

https://www.infarmed.pt/web/infarmed/licenciamento-mais

https://www.ctvnews.ca/health/man-credited-with-decriminalizing-drugs-in-portugal-not-sure-legal-cannabis-is-the-right-move-1.4131841

https://dre.pt/dre/detalhe/lei/33-2018-115712242

https://dre.pt/dre/detalhe/lei/83-2021-175397114

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