The web-based eAF timeline has been updated on the PML Portal!

The updated PLM (Product Lifecycle Management) Portal web-based electronic Application Form (eAF) for Human medicinal products release timeline is available.

April 19, 2023

| Regulatory Operations: eCTD and Submissions

This update involves the following key milestones:

June 2023 – CAPs and NAPs data transfer starting
August 2023 – data transfer completion for all CAPs and NAPs
November 2023 – User Acceptance Testing
Q1 2024 – transition period starting date confirmation
Q2 2024 – transition to mandatory use of web-based eAF for human variations

Please note that timelines to view migrated PMS product data in the Product User Interface on the PLM Portal will be announced in the future.

For further information, you can contact us at: [email protected]

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The web-based eAF timeline has been updated on the PML Portal!

The updated PLM (Product Lifecycle Management) Portal web-based electronic Application Form (eAF) for Human medicinal products release timeline is available.

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About

Team

Partners

CSR

AI Ethic Code

Careers

The web-based eAF timeline has been updated on the PML Portal!

The updated PLM (Product Lifecycle Management) Portal web-based electronic Application Form (eAF) for Human medicinal products release timeline is available.

Search

Filter by category

Related news and events

eCTD Manager & EURS Validator 24.10 Campaign | EU eCTD v3.1 & Validation Criteria 8.1 Release

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NEW | EMA key updates on Product Management Service xEVMPD for MAHs

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