Module 5 Presentations

05/07/2024

Auxiliary Medicinal Products

• Ideally should be licenced in EU or ICH region, so no dossier required outside SmPC • Where not licenced, or repackaged then IMPD may be necessary to support use in CTA • Modules will depend on modification, and simplification with cross reference should be achievable • Refer to: – Auxiliary Medicinal Products in Clinical Trials 28-Jun-2017 [CT-Reg]

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Amendments to the IMPD

• To be expected throughout development • Where minor, document – this is where per section versioning helps • Substantial modifications will typically be filed and be a snapshot of all changes at the time • CHMP IMPD guidelines provide illustrations of amendments and their classification • For authorised products, Art 64 of CTR clarifies that modifications are managed under the MA

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