CRED Managing Variations Effectively

Common deficiencies leading to rejections (3)

 Scientific/specific change codes • Some change-specific issues where the application had been incorrectly submitted as a Type IA variation • Change in batch size FP of gel/ ointment: default Type IB (CMD Q&A) • Change in manuf. process of active substance (ASMF) • Type IB if the change refers to the restricted part • Increase batch size API/FP up to x10: current scale approved by TIA • QP declaration – API: • Missing, incomplete (sites omitted), invalid (lack of audit) • New QP declaration is required for new source of API and for new batch release site

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