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Cannabis - Requirements and proceedings regarding the granting of authorisations for the performance of activities related to cannabis based medicines, preparations and substances

On April 15, 2021, it was published on “Diário da República” the Order no. 83/2021, which defines the requirements for the submission of requests and proceedings regarding the granting of authorisations for the performance of activities related to growing, production, wholesale trade, transport and circulation, import and export of cannabis based medicines, preparations and substances for medical, veterinary-medical and scientific research purposes, as well as authorisations for the performance of the activity of growing cannabis for other purposes, namely industrial, and security measures to adopt (the “Order”), among which we highlight the following:


- Import and Export
The import and export operations of cannabis based medicines, preparations and substances for medical, veterinary-medical and scientific research purposes shall only be carried on by entities authorised for the performance of activities related to growing, production or wholesale trade. For this purpose, INFARMED, I.P. (“INFARMED”) shall issue a certificate evidencing the prior authorisation for each operation.


- Security measures
It shall be adopted security systems for the development of growing, production, wholesale trade, transport and circulation, import and export activities of cannabis based medicines, preparations and substances for medical, veterinary-medical and scientific research purposes. In addition, the facilities in which said activities are carried on shall be of conditional and restrict access and have a physical and electronic security system that complies with the minimum requirements better detailed in the Order.


- Assessment and opinions
When assessing the applications for authorisations for medical, veterinary-medical and scientific research purpose, INFARMED shall consult (i) the Services for Intervention on Addictive Behaviours and Dependencies (“SICAD”), whose negative opinion shall bind INFARMED to refuse the application and (ii) the Office of Planning, Policy and General Management, the General Directorate of Food and Veterinary, IAPMEI – Agência para a Competitividade e Inovação, I.P. and the Judiciary Police whose opinions are non-binding.

- Decision of documental suitability
After analysis, INFARMED decides on the documental suitability or unsuitability of the applications for authorisations for growing, production, wholesale trade, respective transport and circulation, import and export activities of cannabis based medicines, preparations and substances for medical, veterinary-medical and scientific research purposes and notifies the applicant. However, this decision does not grant authorisation for the development of growing, import and export of cannabis vegetal species.

- Inspection for medical, veterinary-medical and scientific research purposes
In case of request for authorisation for medical, veterinary-medical and scientific research purposes, the applicant shall request to INFARMED the inspection to the facilities, within six months from the suitability notice.

- Authorisations and certificates of good practice
The authorisations issued are in electronic form and published in INFARMED website. As regards the activities of production of cannabis based medicines, preparations and substances for medical, veterinary-medical and scientific research purposes, and of wholesale trade, INFARMED shall also issue an authorisation and certificate of goof practice of community model on the European database EudraGMDP. The General Directorate of Food and Veterinary is responsible for issuing an authorisation for growing of cannabis for industrial, obtaining of fibres and seeds not intended for sowing purposes, including for food use, animal food or production of food or compound feed for animals.


The Order no. 83/2021, of April 15, enters into force and takes effect on April 16, 2021.

To access to Order no. 83/2021, of April 15, full text please click here.

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