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A company is applying for MAA for a novel immunotherapy, which of the following statements about Module 1 is not true? Question 2 7 Select

A company is applying for MAA for a novel immunotherapy, which of the following statements about Module 1 is not true?
Question 27Select one:
A.Module 1 is identical across all countries in the EU.
B.Module 1 documents are not part of the eCTD dossier.
C.Module 1 refers to compliance with paediatric plans.
D.Module 1 contains Product Information - SmPC, PIL, Labelling, Mock-Ups, Specimens, PIL User Testing, Braille.

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