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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 Portal
CESP Delivery

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

PLM Portal eAF (DADI)

PLM Portal

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PSUR Repository

Industry access

NCA access
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Projects:

eCTD v4.0

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


For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.


 

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