Portugal & Medicinal Cannabis

Portugal is well known as having perfect conditions to promote the cultivation of medicinal cannabis both in terms of its good soils & optimal weather conditions as well as having a highly skilled and qualified workforce with entrepreneurial mindset.

Another important component in Portugal’s medicinal cannabis industry is the capability and quality of the inspections carried out by The National Authority of Medicines and Health Products (“INFARMED”), which was recently recognized by the US Food and Drug Administration (“FDA”). This recognition of INFARMED by the FDA further elevates Portugal within the medicinal cannabis industry and, from a regulatory point of view, marks it as one of the most distinguished jurisdictions in Europe. This elevated regulatory framework and international recognition  reinforces and confirms EuroCan’s decision to develop its medicinal cannabis business (including cultivation and, in due course, isolation operations) in Mação, Portugal through its wholly owned subsidiary, CECO Wellness, Unipessoal LDA (“CECO Wellness”).

From a legal perspective, it was Law No. 33/2018, of July 18, which established the legal framework in Portugal for the use of drugs, preparations and substances based on the cannabis plant for medicinal purposes.

In August of 2018 the industrial production of cannabis for medical purposes was also legalized in Portugal. The objective of this legal framework was to make medicines, preparations and substances based on the cannabis plant accessible, ensuring that the preparations made available meet all the necessary requirements regarding the demonstration of their quality and safety, thus contributing to the safeguarding and protection of public health.

Under Portuguese law, the entire production chain is fully controlled ensuring that the products are produced in accordance with all good industry practices, expectations and applicable requirements such as GACP and GMP. This makes medicinal cannabis a very regulated market/industry which is always evolving and enforcing companies to comply with the most stringent regulations and guidelines. The regulation which grants an entity permission to undertake the cultivation, manufacture and trade of cannabis for medicinal purposes can only be authorized by INFARMED and is renewed on an annual basis.

CECO Wellness has submitted its application for pre-licencing to INFARMED (which will authorise cultivation of plants to show compliance with capability/quality requirements) and hopes for a favourable response so that it can move forward towards inspection and secure a formal license. The current target is to start building cultivation and production facilities in Q2/Q3 2020.

Miguel Fagundes

Head Pharmacist, EuroCan