eSubmissions Web User Interface (to create the delivery file) will be unavailable between 15:30 and 16:00 on Friday, 1 September 2017. However, Axway gateway will be available for all communities and any files submitted during that time will be put in a queue for processing when the deployments will be completed. If you have any [...]
An updated version of the eCTD v4.0 EU M1 Implementation Guide is available for public consultation. The commenting period has been extended to allow sufficient time for thorough review by pharmaceutical companies, vendors of eCTD building and reviewing tools and competent authorities. The new date to submit your comments is 20th of October 2017. Please [...]
Pharmacovigilance Working Party Recommendations CMDh Recommendations Harmonisation of SmPCs - Article 30 Referrals Core SmPC/PL
A defect in section 1.1 of the MAA human eAF, affecting the PRAC rapporteur field (Centralised Procedure applications) has been detected and subsequently fixed. New version v.1.20.0.1 of the MAA human form and the updated release notes are now available
Referral decisions and new product information changes can be found on: the European Commission website - (EU languages only) this includes (Union) referral procedures (in accordance with articles 29(4); 30; 31(1); 31(2) or 107i of Directive 2001/83. EMA website – (EU and EEA languages) all procedures, including CMDh positions on PRAC (Union) referrals for solely nationally [...]
New versions of the 4 electronic Application Forms (eAF v. 1.21) and the related release notes are now available. This version of the forms provides usability improvements and defect fixes and aims to improve the user experience for all users. This new version, 1.21 of the forms can be used as of today (20th June [...]
PSUR/eSubmissions Web User Interface (to create the delivery file) will be intermittently unavailable between 09:00 and 19:00 on Saturday, 24 June 2017 due to essential maintenance. EMA's gateway will remain available for all communities throughout and any files submitted during that time will be put in a queue for processing once the deployments have been [...]
Due to essential maintenance between Friday, 16th June 2017 17:00hrs and Sunday 18th June 2017 23:30hrs (UK time), EudraVigilance Human (for ICSR and Product) and EudraVigilance Veterinary (including EV Web and Gateway) will be unavailable. For any questions, please contact the EMA Service Desk
Version 1.21 of the eAFs will become available on 20 June 2017. The release v1.21 will provide usability improvements and technical defect fixes. We are organising a User Acceptance Testing (UAT) to support the release of this next version of the forms: The testing by Industry and NCAs will take place Industry: from Mon 22/05/17 [...]