EU Telematics PIM � _

Human eSubmission




Human eSubmission
eCTD v3.2
eCTD EU M1 specification

Veterinary eSubmission
eSubmission expert group

eSubmission expert group documents


External Links



Common Repository


CESP Portal
CESP Delivery

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

PLM Portal eAF (DADI)

PLM Portal

PSUR Repository

Industry access

NCA access



eCTD v4.0

Paediatric submissions




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.

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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