![]() Please note that regulatory guidance referring to how to send re-examination requests will be updated in the following period. Use this unit for requesting re-examination of opinion for MAA, extension, Type II variation, renewal and annual re-assessment as well as Referral procedures This update introduces in the delivery file for Human submissions the option to choose "Re-examination" submission unit for various submission types. New submission unit to be used for requesting a Re-examination of an CHMP OpinionĪn updated version of the eSubmission Gateway XML delivery file user interface will be available starting with 1 December 2023, 18:00 CET. It is mandatory to use XML delivery files for submissions via the eSubmission Gateway and the Web Client. The use of the eSubmission Gateway and the Web Client is mandatory for all human and veterinary submissions. The Gateway and the Web Client users will benefit from an automated confirmation of the technical validation feedback and an automated upload to the Agency’s eCTD review system. The web-based Gateway Web Client may be more suitable for small and medium-sized companies, however it is available for all applicants. The eSubmission Gateway and the eSubmission Gateway Syncplicity Web Client are electronic submission channels that allow the applicants to submit documents supporting all types of applications for human and veterinary medicines to the Agency securely over the internet in structured and non-structured formats. ESubmission Gateway and eSubmission Web ClientĮSubmission Gateway & eSubmission Web Client
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |