Portugal is a European Union (EU) member country and is subject to European Union Directives and
Guidelines. Additional national registration and language requirements for manufacturers outside of the EU may be applicable. Consult with Country Competent Authority Websites below for detailed country requirements
European Commission Official EU Website
European Medicines Agency (EMA)
National Authority of Medicines and Health Products (Infarmed)
PORTUGAL – REGULATORY GUIDANCE/PROCEDURES
Medicines for Human Use -Infarmed -Regulations
Medicines – National Requirements
Medicines -INFOMED -Drug Database
Medicines – Authorization to Market
Medical Devices – Infarmed -Regulations
Medical Devices – Placement on the Market
Medical Devices – Medical Device Information – infoDM
Medical Devices – Medical Device Information System – SIDM Portal
PORTUGAL- REGULATORY LINKS
OECD Regulatory Policy: Portugal
WHO Health Data: Portugal