Product Registration

Workflow steps

1. Product Registration Intent
   Registration required for domestic sale in Portugal. Full pharmaceutical dossier required. Processing approximately 12–18 months.
   • Full pharmaceutical dossier
   • EU-GMP Part I certificate
   • Clinical data / bibliographic evidence
2. Product Dossier Preparation
   Full pharmaceutical dossier including quality, safety, and efficacy data. May use bibliographic evidence for well-established use applications.
   • Quality module (EU CTD format)
   • Non-clinical and clinical data
   • GMP/GACP certificates
   • Proposed SmPC and labeling
   • Environmental risk assessment
3. INFARMED Product Registration
   Submission to INFARMED. Full pharmaceutical review. Processing approximately 12–18 months.
   • EU CTD-format dossier
   • Proposed Portuguese labeling
   • Risk management plan
   • Processing: approximately 12–18 months
4. Registration approved?
   INFARMED reviews the dossier and may request additional data or clarification during the review process.
5. Product Registered ✓
   Product registered for sale in Portuguese pharmacies and hospitals. May also pursue mutual recognition or decentralized procedure for other EU markets.