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Step 12 - Agree CHMP conditions and submit CHMP for approval

Where the Sponsor, HA and RAP cannot agree on the CHMP conditions, DPC assistance is available. It is advisable this be used at this point, as this is the final opportunity to resolve such disagreements before the CHMP is submitted for approval.

Where the Sponsor, HA and RAP cannot agree on the CHMP conditions, DPC assistance is available. It is advisable this be used at this point, as this is the final opportunity to resolve such disagreements before the CHMP is submitted for approval.

Updated

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