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https://esubmission.ema.europa.eu › gateway › Web Client Q&A…
Q3 Which types of applications can I submit via the EMA eSubmission Web Client The eSubmissions Gateway Web Client service is offered for all Centralised Procedure applications for Human

https://esubmission.ema.europa.eu › tiges › vetesub.htm
The users should note that they should always select the standard timetable E S R for each scope regardless of a different TT having been agreed For grouped VRA in the delivery file the applicant

https://esubmission.ema.europa.eu › psur › docs › PSUR Reposi…
The obligation to submit to the PSUR Repository does not apply to products that have been given a positive CHMP scientific opinion under Article 58 of Regulation EC No 726 2004 For further

https://esubmission.ema.europa.eu › psur › psur_repository.html
The XML delivery file must be included within the submission package i e in the relevant ZIP file It is essential that all MAHs who have not previously used the eSubmission Gateway Web Client

https://esubmission.ema.europa.eu › central_repository.HTML
The Marketing Authorisation Holders submit applications only once to the European Medicines Agency and there should be no further submissions of any CDs DVDs or CESP submissions to any individual

https://esubmission.ema.europa.eu › psur › docs › psur_docs › P…
It is strongly recommended to submit to the PSUR repository to ensure that all MAHs are familiar with the system The use of the PSUR Repository will become mandatory for all PSURs from 13 June

https://esubmission.ema.europa.eu › esubmission.html
ESubmission Gateway and eSubmission Web Client The eSubmission Gateway and the eSubmission Gateway Syncplicity Web Client are electronic submission channels that allow the applicants to

https://esubmission.ema.europa.eu
If an applicant wishes to submit multiple files in one section where only one highly recommended name is available this can be achieved by using a suffix to the filename such as using the file name

https://esubmission.ema.europa.eu › tiges › docs
If an applicant wishes to submit multiple files in one section where only one highly recommended name is available this can be achieved using a suffix to the filename such as using the file name var pdf