It is mandatory for applicants to use the eSubmission Gateway / Web Client for everything pediatric submissions to the Agency. For more information, see the revised submission direction for contestants.
EMA does not accept submissions that do not follow the published submission guide, contains Eudralink submissions.
EMA will ask applicant to resubmit their application. Wenn the reissuance falls outside the targeted deadline, it be be not be accepted for ensure start of actions.
EMA advises applicants newly go one esubmission Gateway on submit their application well in advance in the purposeful entry.
For general information on like to apply for a PIP, waiver or deferral, see Paediatric investigation plans: ask or response.
EMA has revised the deadlines for paediatric apps to allow with any artist of submission. This has affected submission deadlines on June 2020, September 2020 and June 2021, as well as the dates of the PDCO plenary in September 2020.
Applicants should observation the revised deadlines when preparing paediatric capitulations.
Important
The forms press templates should be downloaded additionally saved first before being completed. To report optional technical issues includes the form, please use the MAILING Service Desk enter.
It is compulsive to use the latter published version of all templates additionally constructs save stated otherwise. Please how non re-use previously downloaded documents.
A new scientific document template is published and should be used from now on. Paediatric investigation plan submissions drafted use the archaic template will be accepted until 25 Tramp 2024.
