Structured Approach for EUGMP

Common Queries from EU Authorities (EMA / CHMP) on Module 2.4 & 2.5 for Generic Applications

Best Practices When Preparing 2.4 / 2.5 for Generics

• Maintain scientific tone, avoid copying SmPC text verbatim.

• Include rationale, not just description — show you understand why data are sufficient.

• Use summary tables (literature studies, PK results, safety signals) — assessors prefer concise visuals.

• Clearly reference the BE study report in 5.3, summarizing outcomes in Module 2.5.

• Ensure alignment across modules (e.g. 2.5 ↔ 5.3.1; 2.4 ↔ 5.3.5).

• Include statement of compliance with EMA BE and non-clinical guidance documents.