Clinical trials are a universally recognised method of performing research and development activities. The COVID-19 pandemic has made clinical trials even more important, particularly to bring effective drugs to combat the disease to the market as soon as possible. The National Authority for Medicines and Healthcare Products has published various measures which aim to mitigate the risks that the pandemic may pose to patients who participate in clinical trials.
In Portugal, those who wish to place cannabis-based medicinal preparations and substances on the market must obtain a marketing placement authorisation (MPA) from the National Authority for Medicines and Healthcare Products. The preparations or substances may then be sold in pharmacies subject to medical prescription. This article answers questions regarding how to obtain an MPA.
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. This article answers some of the most important questions regarding the licensing of certain activities involving these products, substances and preparations.