eSubmission in eCTD format is mandatory for all PMF applications including new PMF certification and changes (variations).
Before submission an XML delivery file must be created and included in the submission package. It is important that the guidance is followed step by step.
Dossier preparation and submission
Applicants should prepare their PMF dossier for submission in line with the below format and dossier Scientific data content guidance.
Previously created delivery files should continue to work, however, it is always recommended to clear the cookies and the cache to ensure that the system works correctly.
The eCTD submission format is mandatory and the only acceptable electronic format for all applications according to the EU dossier requirements.
In order to maintain the eCTD dossier lifecycle, all modifications must be reflected in a new eCTD sequence. Therefore, the eCTD requirement is also applicable for all subsequent submissions (e.g. responses to the validation, list of questions, withdrawals, consolidated eCTD sequence).
Replacement eCTD sequences of a previously submitted eCTD application (e.g. following corrections) are not acceptable.
The eCTD dossier content should include a Cover letter, application form, scientific content dossier and when applicable working documents.
The EMA requires a cover letter which should include standard administrative information for each submission.
Please refrain from sending additional and separate copies of cover letters, as they will create delays in processing.
The for application forms for Plasma Master File certificate and variation
Submission to the EMA
The use of the eSubmission Gateway or the eSubmission Gateway Syncplicity Web Client is mandatory for all PMF eCTD submissions.
More information on how to register and submit to the eSubmission Gateway / eSubmissions Syncplicity Web Client can be found from the eSubmission website.
An XML delivery file must be created and included in the submission.
Submissions sent to EMA via eSubmission Gateway/Web Client will be considered delivered to all National Competent Authorities' representatives and alternates.
The above method and requirements also apply to the submission of responses to List of Questions.
The link to PMF Submissions dates can be found here.
Validation of the application
An automated 'acknowledgement' is sent from the system confirming whether their submission has passed the relevant technical validation criteria and has been uploaded to the agency's review tool and made available via the Common Repository.
This eCTD valid Technical Validation for the submission should be pass for the dossier to be accepted. After this 1st step, the validation of the dossier content can start.
During this phase the Agency may request additional information to complete its validation of the dossier and subsequent start of the assessment. The submission of responses to validation supplementary information (VSI) should be also sent in accordance with eCTD requirements.
In order to start the procedure by the targeted start date, the applicant is required to provide the information requested within a given deadline.
After validation of the application, the Agency will notify the applicant accordingly and coordinators in writing.
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.