Short delay in the start of the UAT
There is a short delay in the start of the UAT for the eAF v1.24.0.0 – new dates will be communicated very soon. If you wish to participate in the UAT, please register by email with eSubprogofficer@ema.europa.eu
A new version of the eSubmission Gateway XML delivery file now available
An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update has introduced an additional submission unit for PAM submissions and a mandatory selection of yes/no to indicate if a change of MAH is included in a response submission for MAA human and vet. Additionally some minor [...]
Formatted Table Template implementation in the XML delivery files – now live
A new version of the eSubmission Gateway XML delivery file user interface is now available. Following this release the use of the Formatted Letter template will become obsolete as of 1st January 2020. This will concern all EMA Human and Veterinary submissions (including PSUSA procedures) and after this it will be optional for applicants to [...]
Essential maintenance to computer applications on Wednesday 09-10-2019
PSUR and eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07:00-09:00hrs (CEST) on Wednesday, 9 October 2019. However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete. If you have any questions, [...]
Alerta Farmacéutica R_40/2019 – Vimpat 10 MG/ML Jarabe, 1 frasco de 200 ml
VIMPAT 10 MG/ML JARABE, 1 frasco de 200 ml. Retirada del mercado de todas las unidades distribuidas del lote 5845802 y devolución al laboratorio por los cauces habituales.
Jornada sobre autorización de ensayos clínicos con Organismos Modificados Genéticamente
Madrid, 14 de octubre de 2019
Recepción de notificaciones de sospechas de falta de eficacia del medicamento veterinario MAXIVAC HEPTA
La AEMPS ha recibido un número elevado de notificaciones de sospechas de falta de eficacia de Maxivac Hepta (nº reg. 1509 ESP), ya que el medicamento habría sido administrado como primovacunación, en lugar de como revacunación anual, tal y como se especifica en la ficha técnica del medicamento. Se informa a los profesionales sanitarios veterinarios [...]
Version 1.23.1.3 of the 4 electronic Application Forms (eAF)
Version 1.23.1.3 of the 4 electronic Application Forms (eAF) will be available 10 October 2019. The release v1.23.1.3 is a bug fix release to correct a number of issues affecting the forms. More details on the fixes will be available in the release notes which will be published together with the updated forms. This hotfix [...]
Alerta Farmacéutica R_37/2019 – Varias presentaciones de ranitidina del titular de la autorización de comercialización TEVA PHARMA, S.L.U.
Retirada del mercado de todas las unidades distribuidas de los lotes de este medicamento y devolución al laboratorio por los cauces habituales