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Human eSubmission

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Veterinary esubmission
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eSubmission CMB

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CMB Documents
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External Links

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Systems:

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Common Repository

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eAF

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CESSP

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eASMF
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ePMF
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CESP
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eSubmission Gateway & eSubmission Web Client

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Delivery file UI

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eSubmission Gateway

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PAM submission form

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PSUR Repository
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Industry access

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NCA access
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eCTD

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eCTD v4.0

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EU Module 1

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Paediatric submissions

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SPOR

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eSignatures

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These documents have been created/adopted by the eSubmission CMB or by the TIGes.

HMA eSubmission Roadmap

Annexes to the eSubmission Roadmap

  • Annexes are being reviewed to reflect the updated version of the eSubmission roadmap version 2.1.

EU Harmonised eCTD Guidance

EU Harmonised NeeS Guidance

EMA eSubmission Guidance for the Centralised Procedure

  • All EMA guidance documents, both practical and strategic, as well as Statements of Intent relating to eCTD and electronic submissions, can be found on the EMA external website here.

Best Archiving Practice

 

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