EU Telematics PIM _
 

Human eSubmission

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Home

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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

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Veterinary eSubmission
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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:

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eCTD v4.0

CESSP

Paediatric submissions

SPOR

eSignatures

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The Human Harmonisation Group (HHG), is a subgroup of the eSubmission expert group and is made up of representatives from National Competent Authorities, the EMA and Industry. Its objective is to develop and implement standards and technical guidance documents for the submission of electronic information in the context of European approval procedures for human medicinal products. The documents are approved by the eSubmission expert group before publication.

The documents are published under the eCTD v.3.2.  or the eCTD EU M1 specification webpages.


 

 


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