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Cannabis for Medical The Law for Cannabis for Medical Use was passed now enjoys a more precise legal framework, thus in 2018, was regulated in 2019 and since then 11 providing legal certainty to interested players in companies have been licensed by Infarmed for the developing this activity in Portugal. cultivation of cannabis in Portugal. On 15 April, an REGULATION OF THE CANNABIS LAW FOR Ordinance was published that extended the MEDICINAL PURPOSES requirements for obtaining authorizations, in particular the security measures that must be In 2019, in accordance with the regulation of the observed by companies already licensed on or Cannabis Law for Medicinal purposes, a legal before the 15 July 2021. framework was then provided for the entire chain of medicines and preparations and substances based on CANNABIS FOR MEDICAL USE - LEGAL the cannabis plant intended for human use for FRAMEWORK IN PORTUGAL medicinal purposes (Decree-Law 8 / January 15, In 2018, the “Law for Cannabis for Medical Use”, 2019). created the legal framework for the use of medicinal These regulations apply not only to specific aspects products, preparations and substances based on the related to the introduction in the market, prescription cannabis plant, for medicinal purposes, in Portugal and dispensation of these drugs and substances, but (Law No. 33/2018 of 18 July). also to all activities that are upstream. This law aimed at regulating prescription and Consequently, as of 2019, the cultivation, production, dispensation in pharmacy, detention and extraction and manufacture, wholesale trade, import transportation, scientific research and information for and export, transit and acquisition of cannabis in professionals, as well as the regulation and supervision Portugal, acquired a legal framework that allowed the of activities related to the use of cannabis for medicinal development of this economic activity in Portugal. purposes. For the purpose of controlling these activities, a specific The law provided the framework for all activities in the office for Medical Cannabis was created within chain of this plant, and so the cultivation, manufacture Infarmed (the National Authority for Drugs and Health and distribution of cannabis for medicinal purposes Products). 1 On the other hand, the Military Laboratory of Chemical with the requirements of the computer system and Pharmaceutical Products was legally authorized to that guarantees product traceability and with produce medicinal products, preparations and the site security requirements. substances based on the cannabis plant, thus Between 2019 and 2021, based on this respecting the provisions of international treaties that framework, Infarmed issued 11 authorizations establish that signatory countries that allow the use for the cultivation of Cannabis for Medicinal cannabis for medicinal purposes should establish Purposes to establishments located in Lisbon, Portalegre, Braga, Setúbal, Coimbra, Faro and structures to control cannabis production and supply. Porto. PREPARATION OF THE DOSSIER Two wholesale authorizations were also issued, as well as one import authorization and one export authorization. In Portugal, only one The activities of cultivation, manufacture, wholesale trade, import, export and transit of cannabidiol drug is approved. medicinal products, preparations and substances based on Medical Cannabis require authorization from Infarmed. ORDINANCE NO. 83/2021 OF 15 APRIL Although the authorizations do not have a On 15 April, the Ordinance which determines the validity, the basic information must be updated requirements and procedures related to the granting of annually, under penalty of expiration. authorizations for the exercise of activities related to The preparatory activities necessary to submit the cultivation, manufacture, wholesale trade, the application for obtaining the authorizations, transport, circulation, import and export of medicinal in particular the cultivation authorization, are time consuming and involve several aspects. products, preparations and cannabis-based substances was finally published (Ordinance No. In specific, 1) the regulatory aspect, of 83/2021 of 15 April). identifying and complying with all applicable regulatory and security requirements, 2) the The approval of this regulation by joint Ordinance of the corporate aspect, of creating a company with members of the Government responsible for the areas the necessary characteristics for the exercise of finance, home affairs, justice, health, economy and of the activity and, finally, 3) the real estate agriculture, had been expected since 2019. aspect, involving the acquisition or rental of the property and compliance with the requirements With the publication of these rules, the intention was to relating to the location of the property. clarify the rules, requirements, and procedures for the On its website, Infarmed provided models of licensing of activities related to Cannabis for Medicinal the application forms to be submitted by Purposes, with the expectation that it will dispel any applicants and some information on the doubts that have arisen so far that have contributed to processing of applications, listing the the lengthy preparation of the application dossier. documents to be attached and their respective content. These rules also apply to cannabis for medical- In the preparation of the submission form for veterinary, food and industrial purposes. obtaining the authorizations, applicants are faced with various unresolved questions in REQUIREMENTS FOR OBTAINING relation to the how legal requirements are AUTHORIZATIONS applied to each specific case, partly due underdeveloped legal requirements. In Obtaining authorizations depends on particular, questions are recurrently raised meeting a set of legal requirements, which regarding the identification of the necessary can be summarized in two large groups authorizations for the execution of an (below specifically regarding the investment project, regarding the corporate authorization for cultivation): structure and the requirements applicable to the managers, but also regarding the qualifications of the Responsible Technician, 2 (a) Quality guarantees: Technician and proof of the respective technical qualifications; For the location and facilities, the geographic location of the place And also with regard to the where the cultivation activity will be identification of the farmer(s), in case carried out must be provided, as well this is not the applicant, and the as the respective plant and the identification of suppliers and/or description and location of the recipients of the products, proof of warehouse facilities where the authorization by the respective product is stored, and a lease or national or foreign competent certificate of land registry; regulatory authority must be provided. Regarding the absence of restrictions on the cultivation of the (a) The safety guarantees: cannabis plant by the City Council where the land or facilities where the As for the people involved, criminal activity will be carried out are located; records are required for all members of the board of directors or the As for the consistency of the project, manager(s) of the company, as well as a business plan for the project must the technical person in charge, the be submitted, including the 3-year person in charge of security and the forecast of the financial investment farmer; plan and growth in the number of employees and indication of As for the implementation of security quantities of product to be sown or measures, proof of implementation of planted, as well as the estimated such measures is required, as well as quantity of the product to be the identification of the security harvested, its use and destination director, who must sign a term of and the identification of the stages of responsibility. development of the plant and description of the techniques used in each stage of cultivation and the beginning of the cultivation and THE PROCEDURE FOR OBTAINING harvesting activity (after issuance of AUTHORIZATIONS the authorization); Finally, with regard to the procedure for obtaining Regarding compliance with good authorizations, it should be noted that the submission practices in Agriculture and of the application and accompanying documentation is Harvesting - Guideline on Good done online, on the Infarmed website. Agricultural and Collection Pratice (GACP), published by the European After submission, a period of analysis and opinions Medicines Agency, through the follows, during which the following opinions are implementation of procedures requested by Infarmed: related to the activities carried out by the entity, namely regarding (i) from SICAD - Service for Intervention in reception, storage, process plant Addictive Behaviors and Dependencies (which will do cultivation and harvesting, so within 30 days, the opinion being mandatory and packaging, product shipping, binding) and, personnel involved in the activities, transportation, product traceability (ii) from the Office of Planning, Policies and records, security of the facilities; General Administration (GPP), the Directorate-General for Food and Veterinary (DGAV), to IAPMEI - Agency As for the compliance with technical for Competitiveness and Innovation, IP (IAPMEI), and standards and responsibility for setting them by the Responsible to the Judicial Police (PJ), (which shall issue their respective opinions within 10 days, within the scope of 3 their respective competences and attributions, and For this purpose, a period of 90
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