Introduction
The research and development (R&D) of medicinal products is important both from an individual perspective, considering its objective to identify and treat pathologies (with the consequent improvement in patients quality of life), and from a collective perspective, considering its role in controlling the spread of diseases or eradicating them altogether. R&D activities can be defined as activities carried out in humans (who may be healthy or ill) to:
improve knowledge of pathologies;
identify forms of treatment.
R&D activities are subject to legal and regulatory frameworks and practitioners must comply with various requirements, including:
respecting the human dignity principle and trial subjects fundamental rights;
Introduction
In the past three years, significant changes have been made to the legislation that governs the medicinal use of products, substances and preparations based on the cannabis plant.
The main changes were introduced by Law 33/2018 of 18 July 2018 and Decree-Law 8/2019 of 15 January 2019. Provision was also made for the subsequent publication of a ministerial order to define the rules on:
the security measures to be adopted;
the application process and procedures to grant authorisations relating to the cultivation, manufacture, wholesale trade, transit, import and export of medicines, substances and preparations based on the cannabis plant for medical, medical-veterinary or scientific purposes; and
First cannabis-based substance for medicinal purposes approved
The National Authority for Medicines and Health Products (Infarmed) has approved the first substance based on the cannabis plant for medicinal purposes in Portugal.
“This is the first and only cannabis-based preparation or substance for medicinal purposes allowed in our country and we are planning in the near future to make other products accessible to patients in Portugal , says Rita Barata, general director of Tilray Portugal, located in Cantanhede, in the district of Coimbra, in a statement sent to
The Portugal News.
According to the official, patient “demands are increasing and Tilray s mission is to provide the “safest and best quality products that comply with their needs .