Portugal is a dynamic EU market with growing opportunities for pharmaceutical and medical device manufacturers, supported by a modern healthcare system and full access to the European single market.
The Portuguese National Authority of Medicines and Health Products (INFARMED, I.P.) is the competent authority responsible for regulating medicines, medical devices, cosmetics, and other health products in Portugal. As an EU Member State, Portugal fully implements centralized procedures via EMA for medicines and MDR/IVDR for medical devices, with INFARMED managing national procedures, decentralized/mutual recognition procedures, clinical trials, pharmacovigilance, vigilance, and local compliance requirements. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate Portugal’s EU-harmonized framework, prepare high-quality submissions, secure efficient approvals, and ensure sustained compliance in this strategic Southern European market.
Get Portugal Compliance Support
Expert CTD/eCTD dossier compilation, Module 1 Portugal-specific adaptation, scientific/technical review, and quality assurance for INFARMED/EMA submissions.
Complete management of national, DCP, MRP, and centralized submissions via INFARMED and EMA, including validation, follow-up, and query responses.
Preparation and submission of CTAs/CTIS applications to INFARMED, ethics committee coordination, and regulatory support for clinical trials in Portugal.
Portuguese QPPV/local contact person services, PSUR/PBRER submissions to INFARMED/EMA, adverse event reporting, signal detection, and RMP maintenance.
CE marking support, Notified Body liaison, conformity assessment, vigilance reporting, and INFARMED registration/oversight compliance in Portugal.
PMS/PMSR implementation, trend reporting, FSCA notifications, vigilance compliance, and ongoing monitoring per INFARMED and EU requirements.
Portuguese labelling review, Blue Box/EEA requirements, mock-ups, readability testing, and INFARMED approval support.
Support for post-approval changes, renewals, line extensions, and full lifecycle compliance with INFARMED and EMA/EEA standards.
Strategic consulting, pathway selection (centralized/national/DCP/MRP), INFARMED scientific advice preparation, and up-to-date Portuguese/EU regulatory intelligence.
Partner with Medwisdom for expert, efficient, and fully compliant regulatory support in Portugal — from INFARMED/EMA submissions and MDR/IVDR compliance to pharmacovigilance, lifecycle management, and sustained EU market success.
Contact Our Portugal Regulatory Experts