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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

eSubmission expert group documents

External Links

Systems:

Common Repository

eAF

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

PLM Portal eAF (DADI)

PLM Portal

Projects:

eCTD v4.0

Paediatric submissions

SPOR

eSignatures

ICH

• ICH: http://www.ich.org
• ICH electronic Common Technical Document (eCTD): http://estri.ich.org
• ICH Specification 3.2 (Modules 2 - 5) (Notice to Applicants Vol 2B): http://estri.ich.org/eCTD/index.htm
• ICH Q&As: http://estri.ich.org/ectd
• ICH ETICS M2 Project: http://www.etics.us

EU Change Control Process

• The EU Change Request Tracking table - (October 2013)
• The new agreed Change Request Process (June 2011)
• The Electronic Submission Change Request Q&A form (June 2011)

General eSubmission Links

• ICH M2 (Q&A or Change Request Form)
• eCTD Plasma Master File Guidance
• Submission of data for authorised medicinal products for human use (Article 57 submissions)

National Agency e-Submission Guidance

• Austria
• Belgium
• Denmark
• IMB, Ireland
• France (ANSM)
• Germany (BfArM)
• Netherlands (MEB)
• Spain
• Sweden
• United Kingdom (MHRA) (Special Mail 5)

Eudralex Volume 2 - Pharmaceutical Legislation: Notice to Applicants

• http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/index_en.htm

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.