Abstract
The prescription, supply and use of medicines should centre on their rational use, in order to foster patients’ interests and integrity, and promote public health and national economic sustainability. The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country’s legislative framework in order to understand the regulation, approval, and marketing of medicinal products for human use. Portugal has played an important role in the European Union and European Economic Area as a Reference Member State (RMS). The aim is to describe the main statutes and procedures governing medicinal products for human use in Portugal, as well as the role of the country's National Medicines and Health Products Authority.
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