Product Registration

Workflow steps

1. Registration Intent
   Full pharmaceutical dossier required for AIFA registration (AIC — Autorizzazione all'Immissione in Commercio). FM2 (SCFM domestic) bypasses this — it is manufactured by a state entity. Processing: approximately 12–24 months.
   • Full pharmaceutical dossier
   • Clinical data package
   • EU-GMP Part I certificate
2. Product Dossier Preparation
   Full pharmaceutical dossier per AIFA requirements. Includes quality, non-clinical, and clinical modules aligned with EU CTD format.
   • Quality module (CTD Module 3)
   • Non-clinical module (CTD Module 4)
   • Clinical module (CTD Module 5)
   • EU-GMP Part I certificate
   • Product specifications and stability data
3. AIFA Product Registration
   Submission to AIFA for AIC (Autorizzazione all'Immissione in Commercio). AIFA evaluates quality, safety, and efficacy. Processing: approximately 12–24 months.
   • Complete CTD dossier submitted
   • AIFA fees paid
   • Response to AIFA queries within deadlines
4. Registration approved?
   AIFA evaluates the dossier. May request additional data, clinical studies, or GMP clarification. Processing is lengthy (12–24 months).
5. AIC Granted ✓
   AIFA issues AIC (Autorizzazione all'Immissione in Commercio). Product can be marketed and distributed through Italian pharmacies via SSN or private channels.
6. Address AIFA Deficiencies
   Respond to AIFA deficiencies. Common issues: insufficient clinical data, GMP gaps, or labeling non-compliance. May require additional studies.
   • Written response to all AIFA queries
   • Additional clinical data if requested
   • Updated GMP documentation if flagged