---
title: Updated timeline for the use of eAFs for variations in human drugs | EXTEDO
description: The EMA has published a new timeline of their eAFs (former DADI project).
image: https://www.extedo.com/hubfs/Blog%20Post_%20New%20Timeline%20eAF%20(5)-1.png
---

![](https://www.extedo.com/hs-fs/hubfs/Blog%20Post_%20New%20Timeline%20eAF%20(4).png?width=576&height=265&name=Blog%20Post_%20New%20Timeline%20eAF%20(4).png)

![](https://www.extedo.com/hs-fs/hubfs/b0cb190cbd7efaee1435dde1e0fdaa3c.png)

# Updated timeline for the use of eAFs for variations in human drugs

The European Medicines Agency ([EMA](https://www.extedo.com/glossary-of-regulatory-abbreviations#section_e)) recently released an updated timeline with related milestones for using web-based, electronic application forms ([eAFs](https://www.extedo.com/glossary-of-regulatory-abbreviations#section_e)) for variants of medicines for human use approved through both central and national procedures.  

 The PLM Portal Forum shows the eAFs implementation timeline. It will be as follows:   

- **June 2023:** Data transfer begins. Centrally approved products ([CAPs](https://www.extedo.com/glossary-of-regulatory-abbreviations#section_c)) and nationally approved products (NAPs) will be loaded into the PMS (via [SIAMED](https://www.extedo.com/glossary-of-regulatory-abbreviations#section_s) and [xEVMPD](https://www.extedo.com/glossary-of-regulatory-abbreviations#section_x)) and will be accessible in eAFs. The first NAPs can then be used in the web-based eAFs. After that, the NAPs will be gradually made available in the [PLM](https://www.extedo.com/glossary-of-regulatory-abbreviations#section_p) portal. 

- **August 2023:** Data transfer completion - all CAPs and NAPs are ready to apply the eAFs. 

- **November 2023:** User Acceptance Test (UAT) with the latest version of the web-based eAFs to replace the pdf forms. This will initiate the switch to the new application forms. 

- Confirmation of the changeover start date in **Q1 2024**. This will happen about two months before the scheduled start date and will be determined by the success of the UAT. 

- **Q2 2024:** Begin of the six-month transition period for the required use of web-based eAFs for human medicine variations. This is contingent on the success of the UAT. The transition phase may begin sooner if practicable, subject to the two-month advance notice requirement. 

![EMA_Updated timeline for the use of eAFs for variations in human drugs_II](https://www.extedo.com/hs-fs/hubfs/EMA_Updated%20timeline%20for%20the%20use%20of%20eAFs%20for%20variations%20in%20human%20drugs_II.png?width=2000&height=1125&name=EMA_Updated%20timeline%20for%20the%20use%20of%20eAFs%20for%20variations%20in%20human%20drugs_II.png)

(source: European Medicines Agency)

As extra information, a second version of the updated chronology discusses the consequences for users of eAFs in the various periods. 

- The features necessary for mandatory eAF use will be deployed in stages. However, before the start of the UAT, every essential functionality will be offered in the PLM Portal. 

- The web-based eAF will follow the existing data update process. Structured data will be introduced at some point afterward. 

- In parallel, the capability of displaying migrated PMS product data in the PLM Portal product user interface is being developed; deployment dates will be disclosed later. 

- The UAT's organizational details will be announced in due time. 

 ![EMA_Updated timeline for the use of eAFs for variations in human drugs_1](https://www.extedo.com/hs-fs/hubfs/EMA_Updated%20timeline%20for%20the%20use%20of%20eAFs%20for%20variations%20in%20human%20drugs_1.png?width=2000&height=1125&name=EMA_Updated%20timeline%20for%20the%20use%20of%20eAFs%20for%20variations%20in%20human%20drugs_1.png)

(source: European Medicines Agency)

Use the following options to obtain additional information: 

- [eAF-PMS FAQs](https://esubmission.ema.europa.eu/cessp/eAF%20FAQs%20Document_v1.0.pdf), which contain PMS-related questions and answers 

- [Q&A document](https://www.ema.europa.eu/en/documents/other/questions-answers-dadi-pdf-electronic-application-forms-eaf-training-webinars-26-july-2022-2_en.pdf) for training 

- [Human Variations eAF go-live Q&A](https://www.ema.europa.eu/en/documents/other/questions-answers-human-variations-eaf-go-live-qa-session-27-october-2022_en.pdf) 

- [Human Variations eAF go-live training (2 February 2023)](https://www.youtube.com/watch?v=Jv1_knzKZbM) 

 

If you like to learn more about eAF and its relation to DADI, please go to [Where is DADI? - The new EMA eAF: Definition and Impact | EXTEDO](https://www.extedo.com/blog/where-is-dadi-the-new-ema-eaf-definition-and-impact) 

 

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