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Essential maintenance to PSUR and eSubmission Gateway

Please note that PSUR and eSubmission Gateway File Handler will be unavailable from Friday 12/11/2021 after 18:00, until Monday 15/11/2021 morning 8:00, due to essential maintenance. EMA gateway will, however, remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete.

Por |2022-07-09T04:17:28+00:00julio 9th, 2022|Noticias|Sin comentarios

eSubmission Gateway Web Client upgrade – Syncplicity go-live for production environment on this weekend (8th – 10th July 2022)

As previously announced, the EMA is in the process of upgrading our current Axway Gateway solution. Please note that migration of all users in the Production System will be done this weekend, starting from Friday, 8 July 2022, at 17:00 CEST until Sunday, 10 July 2022, at 18:00 CEST. Should this need to be postponed, [...]

Por |2022-07-05T16:00:00+00:00julio 5th, 2022|Noticias|Sin comentarios

eSubmission Gateway Web Client upgrade – Migration of all (XCOMP) users to Syncplicity ongoing

The issues relating to preparations for the external UAT have been solved and it is now expected that the eSubmission Web Client users can start the user acceptance testing within the next couple of days (XCOMP environment). Please note that internal testing is still ongoing, and it is recommended that external testers do not start [...]

Por |2022-06-10T16:00:00+00:00junio 10th, 2022|Noticias|Sin comentarios

DADI Conceptual Data Models now available

The updated excel sheet listing all fields in the Variation and Medicinal Product has been published on the DADI website on the 23rd of May. The Conceptual Data Models for the human variation form FHIR message and the medicinal product in a variation FHIR message are now also available on the DADI website. The example [...]

Por |2022-06-08T16:00:00+00:00junio 8th, 2022|Noticias|Sin comentarios

DADI Project Update

Following the news published in February 2022 on the updated timeline for the release of DADI web-based variations forms for Human medicinal products further details on the timeline leading to go-live and go-live scope are now available.

Por |2022-05-24T16:00:00+00:00mayo 24th, 2022|Noticias|Sin comentarios

Technical issue on the eAF webpage affecting availability of the latest versions of the eAF v1.26.0.0 has been fixed

The updated versions eAFs (Veterinary MAA and variation, human variation) were published on the eAF website on 20th of January 2022. A technical issue has been identified which means that these latest versions were replaced by earlier versions (at some point around 5th of February). The issue has been now fixed and the latest [...]

Por |2022-02-11T16:00:00+00:00febrero 11th, 2022|Noticias|Sin comentarios

DADI Project Update – Updated timeline for the release of Human variations forms

Following the announcement on the revised timeline made during the first Digital Application Dataset Integration (DADI) Network Project public webinar held on 18 January 2022, an updated timeline for the release of DADI web-based variations forms for Human medicinal products, including key milestones, is now available.

Por |2022-02-04T16:00:00+00:00febrero 4th, 2022|Noticias|Sin comentarios

Veterinary Medicinal Products Regulation (Regulation (EU 2019/6) enters into force – updated eSubmission systems/forms now available for mandatory use

The use of the updated version of eAFs is now mandatory for all new veterinary variations and marketing authorisation applications. Please note that there is no transitional period and the v1.25.0.0 cannot be used for any new procedures starting after 28th January 2022.

Por |2022-01-28T16:00:00+00:00enero 28th, 2022|Noticias|Sin comentarios
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