Ricardo Costa Macedo
ADVOGADO & SÓCIO| LAWYER & PARTNER
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The recently published Ordinance No. 83/2021, which came into force on 16 April, details the requirements and procedures for obtaining authorisations for the exercise of activities related to the cannabis plant in Portugal, and its use for medicinal, medical-veterinary and scientific research purposes.
The legal framework for the use of the cannabis plant for medicinal purposes in Portugal was already laid-down in Law no. 33/2018, of 18 July, and in Decree-Law no. 8/2019, of 15 January.
Now Ordinance No. 83/2021 has brought greater detail and clarity to the legal regime for cultivation, manufacture, wholesale trade, transport, circulation, import and export of medicines, preparations and substances based on the cannabis plant.
Moreover, this Ordinance clarifies the authorisations required for the exercise of the activity of cultivation of the cannabis plant for industrial purposes, and the respective safety measures to be adopted.
This Ordinance enlists the information that must be included in the applications to be submitted before the INFARMED (the Portuguese Drug Authority) for an authorisation to proceed with activities related to the cannabis plant with medicinal, medical-veterinary and scientific research purposes.
The referred Ordinance also sets-forth the information and documents that must be submitted to the DGAV (the Portuguese Directorate-General for Agriculture and Veterinary) in connection to authorisations for the cultivation of the cannabis plant for industrial purposes, obtention of fibres and seeds not intended for sowing, including for food or animal feed use or for the manufacture of food or compound feed.
The development of the referred activities implies the adoption of security systems in accordance with Law No. 34/2013, of May 16. In this sense, the facilities shall have conditioned and restricted access and a physical and electronic security system.
It is furthermore defined that, upon the receipt of the said application, the INFARMED shall request an opinion from the SICAD (the Portuguese Intervention Service for Addictive Behaviours and Dependencies), which will be given within 30 days, in the cases of requests for authorisation to carry out activities related to the cannabis plant.
In the likelihood of the SICAD not issuing a favourable opinion, the INFARMED will have the right to refuse the application.
Under these new rules the INFARMED must also request an opinion from the following entities: GPP (the Portuguese Office of Planning, Policies and General Administration), the DGAV, the IAPMEI (Agency for Competitiveness and Innovation), and the Criminal Police. These entities will provide their opinion within 10 days, within the scope of their respective powers.
The INFARMED should then decide on the documental suitability or inaptness of the application for authorisation for activities related to the cannabis plant, notifying the applicant of its decision.
In addition, the INFARMED shall conduct an inspection to the facilities within a period of six months, as of the notification of the decision of suitability, in cases where an application for authorisation for medicinal, medical-veterinary or scientific research purposes was submitted. The said inspection shall be requested by the applicant.
Where there is a request for an authorisation to manufacture medicines, preparations and substances based on the cannabis plant, the applicant must also submit proof of industrial licensing.
Ordinance No. 83/2021 also foresees that, in certain cases, the PSP (Public Security Policy) may be asked to conduct inspections on the premises where there is storage or manufacture of the cannabis plant to check the conformity of the said premises and the technical equipment with the due safety measures.
If, after these steps, it is found that the facilities comply with the legal and regulatory provisions, the respective authorisation will be issued, published in the Official Gazette and communicated to the applicant and the relevant entities.
It should also be noted that if the intention of the applicant is the cultivation of the cannabis plant for industrial purposes, then DGAV should decide on the applications received within 10 days and issue, where appropriate, the respective authorisation for cultivation.
A final note to clarify that entities that already hold an authorisation for cultivation, manufacture and wholesale distribution of medicines containing narcotic and psychotropic substances, should adopt the safety measures provided for in the said Ordinance within 90 days.
Ordinance No. 83/2021 constitutes a relevant development as regards the licensing of activities related to the cannabis plant for medicinal, medical-veterinary or scientific research purposes, and also as regards the cultivation of the cannabis plant for industrial purposes. The detail and clarity that it brings will be an added reason for entrepreneurs to invest in these businesses in Portugal.
Lisbon, April 27, 2021
Ricardo Costa Macedo | Diana Mâncio da Costa
Caiado Guerreiro, Soc. de Adv., SP RL