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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

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eSubmission expert group
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eSubmission expert group documents

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External Links

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Systems:

Common Repository

eAF

eASMF
ePMF
CESP

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

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PSUR Repository

Industry access

NCA access
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Projects:

eCTD v4.0

CESSP

Paediatric submissions

SPOR

eSignatures

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ICH

EU Change Control Process

General eSubmission Links

National Agency e-Submission Guidance

Eudralex Volume 2 - Pharmaceutical Legislation: Notice to Applicants




 

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