Library / regulatory-reference
Portugal: National Authority of Medicines and Health Products (INFARMED)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
INFARMED, the National Authority of Medicines and Health Products, is Portugal's national regulatory authority for medicines and health products, operating under the Ministry of Health.
Portugal's market sits inside the European single market, and the authority combines regulation with a strong health-technology-assessment role in reimbursement decisions.
How products enter the market
Medicines require marketing authorization through national or European procedures after evaluation of quality, safety and efficacy, and establishments are licensed and inspected by the authority.
Post-market work includes safety monitoring within the European alert network, and the authority's technology assessments decide which authorized products the public system pays for.
Regional and international role
The authority is a senior member of the European regulatory network, contributing assessments and leadership to shared European work.
Its combined regulatory and technology-assessment mandate makes it a model for linking authorization to value-based reimbursement.
Using this profile
The authority publishes regulations, registers and alerts in Portuguese, with English material, through its official portal, which is the primary source for current rules and listed in this profile's internal reference record.
For cross-country comparison: Portugal illustrates the regulator-assessor: one authority spanning market authorization and public-payer value assessment.
Limitations
Educational profile of a national regulatory system, current as of drafting. It simplifies routes and classes and is not legal, regulatory, or clinical advice. Filing and compliance decisions must be confirmed against the authority's current published rules and, where needed, professional regulatory counsel.