title: Medicinal Product Regulation: Portugal׳s Framework.
abstract: The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED).
  
  
  
  From the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required.
  
  
  
  In 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients' safety.
  
  
  
  The Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances.
authors: Department of Medical Sciences and Institute for Biomedicine - iBiMED, University of Aveiro, Aveiro, Portugal; CESPU, IINFACTS, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde, Gandra, Portugal. Electronic address: teresaherdeiro@ua.pt.
authors: Maria Teresa
authors: MT
authors: Herdeiro
authors: Department of Medical Sciences and Institute for Biomedicine - iBiMED, University of Aveiro, Aveiro, Portugal; Chemistry Department, University of Aveiro, Aveiro, Portugal.
authors: Paulo D
authors: PD
authors: Bastos
authors: Department of Medical Sciences and Institute for Biomedicine - iBiMED, University of Aveiro, Aveiro, Portugal.
authors: António
authors: A
authors: Teixeira-Rodrigues
authors: Department of Medical Sciences and Institute for Biomedicine - iBiMED, University of Aveiro, Aveiro, Portugal; Center of Potential and Innovation of Natural Resources Research Unit for Inland Development, Guarda Polytechnic (CPIRN-UDI/IPG), Guarda, Portugal.
authors: Fátima
authors: F
authors: Roque
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D016527:Drug Costs / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D011307:Drug Prescriptions / Q000592:standards; D016568:Drugs, Generic / Q000592:standards; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D040541:Marketing / Q000331:legislation & jurisprudence; D011174:Portugal; D012051:Reimbursement Mechanisms / Q000331:legislation & jurisprudence
chemical_list: D016568:Drugs, Generic
keywords: National Regulatory Agency; Portugal; marketing authorization; medicinal products regulation