About 798,000 results
Open links in new tab
  1. eSubmission
    https://esubmission.ema.europa.eu/eaf

    eSubmission: eAF - Europa

    • PLM Portal eAF (Dadi)

      14-10-2024. Non-Centrally Authorised Products now available in the PLM …

    • MAA-Human XSD

      text choice(“yes” | “no”| “null”)

    • Variation XSD

      eSubmission: Projects

    • Projects

      eAF issues with webservices fixed. The issue affecting the ‘Substance Type’ …

    • Home · PLM

      A secure online portal for managing electronic Application Forms. eAF …

    • Webinars & System Demo…

      This is a dedicated page, serving as a comprehensive repository of essential …

    • Questions & Answers

      Q.1. What is the eAF? (H+V) A: The eAF stands for electronic Application Form …

    • FHIR XML

      EMA is pleased to announce the web-based Human Variations electronic …

    See results only from esubmission.ema.europa.eu
  2. europa.eu
    https://www.ema.europa.eu/en/news/electronic...

    Electronic application forms fully available for use

  3. Searches you might like

  4. PLM Portal
    https://plm-portal.ema.europa.eu

    Home · PLM

    The PLM Portal EMA is a secure online portal for managing electronic Application Forms for medicinal products. It also provides access to product information and data management services.

  5. eSubmission
    https://esubmission.ema.europa.eu/eaf/docs...
    [PDF]

    Practical user guide for electronic Application Forms (eAF

  6. PLM Portal
    https://plm-portal.ema.europa.eu/Guidan…

    eAF - Release Notes · PLM - Europa

    Sep 20, 2024 · Learn about the latest updates and improvements of the web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) on the Product Lifecycle Management (PLM) …

  7. PLM Portal
    https://plm-portal.ema.europa.eu/Guidance/article/KA-01020/en-us

    eAF - Webinars & System Demos · PLM - Europa

  8. People also ask
    What does EAF stand for?
    This User guide has been prepared in order to facilitate the work of applicants when completing the Electronic Application Forms (eAF) as part of an application for a marketing authorisation of a medicinal product for human use / registration of a traditional herbal medicinal products.

    Module 1: Administrative information Application form

    ema.europa.eu
    What is EMA doing to improve the EAF?
    This is a big, first, milestone in the ongoing journey to improve the eAF and related processes. EMA has been collaborating with the UNICOM consortium to develop the human variation form and other new web-forms.

    eAF - Release Notes · PLM - Europa

    plm-portal.ema.europa.eu
    When will EAF be available for centrally authorised products (caps)?
    20 September 2024 EMA is pleased to announce the web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) has gone live on 4th November 2022, on the new Product Lifecycle Management (PLM) Portal. This is a big, first, milestone in the ongoing journey to improve the eAF and related processes.

    eAF - Release Notes · PLM - Europa

    plm-portal.ema.europa.eu
    What is a web-based electronic application form (EAF)?
    A web-based electronic application form (EAF) replaces PDF eAFs used for regulatory submissions in the new dedicated PLM portal. This is a first step towards making the form-filling and submission-handling process more efficient.

    Human variations electronic application forms public training

    ema.europa.eu
    Where can I find a human Maa EAF form?
    Please send any question to plm.valuestream@ema.europa.eu or post them via the PLM Portal Forum. Updated v1.26.0.0 Human MAA eAF is now available on the eAF website. The form is ready for immediate use. The change implemented in this version is a minor bug fix (related to Annex 5.19).

    eSubmission: eAF - Europa

    esubmission.ema.europa.eu
    How will EMA improve the human variation EAF?
    This is a big, first, milestone in the ongoing journey to improve the eAF and related processes. EMA has been collaborating with the UNICOM consortium to develop the human variation form and other new web-forms.Following the release, users of the Human Variations eAF should expect continual work on improvements in the form of regular releases.

    eAF - FHIR XML - Release Notes · PLM

    plm-portal.ema.europa.eu
    Feedback
  9. eSubmission
    https://esubmission.ema.europa.eu/eaf/docs/eAF...
    [PDF]

    eAF – Questions & Answers - Europa

  10. europa.eu
    https://www.ema.europa.eu/en/documents/template...
    [PDF]

    Module 1: Administrative information Application form

  11. europa.eu
    https://www.ema.europa.eu/en/events/human...

    Human variations electronic application forms public training

  12. PLM Portal
    https://plm-portal.ema.europa.eu/Guidan…

    eAF - FHIR XML - Release Notes · PLM - Europa

    Nov 21, 2023 · EMA is pleased to announce the web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) has gone live on 4 th November 2022, on the new Product Lifecycle Management …

  14. Some results have been removed