APPLICATION CHECKLIST (ICH CTD)

For NDAs (chemical) and GDAs submitted under the abridged evaluation route and for which approval has been obtained from at least one of HSA’s reference agencies not more than 5 years before the date of submission to HSA, a colour scanned copy of the completed Dossier Clarification Supplement should be submitted in PRISM under “Other Supporting Documents” (refer to Appendix 18). ................
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