28.01.2014

Update: Electronic Submission of Marketing Authorisation Dossiers

Drug Master File Procedures in the EU, the US and Japan - Live Online Training

Recommendation

17/18 September 2024

Drug Master File Procedures in the EU, the US and Japan - Live Online Training
With updates on the CEP 2.0!

"How and to whom shall I submit my dossier?" - this question is No 28 of EMA's Q&A document on procedural issues in the context of the centralised procedure ("Pre-authorisation Procedural Advice for Users of the Centralised Procedure"; EMA/339324/2007). The answer to this question was updated in December 2013 and describes the approach to the submission of a dossier in the electronical format in the context of the centralised procedure (since the 1st of January 2010, all paper submissions have been rejected). The answer contains references to documents and Guidelines which have been also recently updated.

In the following, you will find a short summary of each chapter:

Language : Only English is accepted.
Format :eCTD is the only acceptable format. The newest electronical standards and specifications (Stand: November 2013) have to be considered. These "Electronic Standards for the Transfer of Regulatory Information (ESTRI)" have been developed by ICH's M2 Expert Working Group and are maintained by the eCTD Implementation Working Group (eCTD IWG). The newest updates concern the standards of module 1 (Regional Information).
Cover letter: No additional and separate copies should be sent, e.g. CD/DVDs, as they will create delays in processing.
Product Information (PI): The PI has to be submitted both within the module 1 of the eCTD (as PDF) and as separate document (in Word format) outside the eCTD structure but in the same eSubmission Gateway.
Active Substance Master File (ASMF): The applicant must ensure that the ASMF (the "closed" part) is submitted as soon as possible by the ASMF holder.
Submission to the EMA.:The dossier should be submitted via the eSubmission Gateway or the eSubmission Web Client. The additional submission of CD-ROM or DVD leads to delays in the handling of applications. Applicants who are not yet using the Gateway or the Web Client (i.e. for technical reasons) should send their applications as CD-ROM or DVD for the attention of the Product and Application Business Support of the EMA (PA-BUS; see Q&A document for the detailed address).
Submission requirements for the different Committee (Co-) Rapporteurs: After receiving the confirmation of technically valid submission of the dossier via the Gateway or the Web Client, the applicant has to send the application electronically to all rapporteurs and co-rapporteurs. If CD-ROM or DVD are used, they have to be sent at the same time to the PA-BUS and to the (co-)rapporteurs who will have the data media when the EMA confirms the validation. This helps avoiding delays.
Validation of the application: In simple words, validation of the application dossier means the confirmation of completeness and compliance to certain standards. In the event that the EMA requires additional information to complete the validation, it will contact the applicant and request the missing information within a specific time limit. The applicant may exceed the deadline up to 2 months. If the Agency receives no response within 2 months, the application procedure will be closed. The applicant has to send his/ her response within the deadline to the EMA and a copy to the (co-)rapporteurs.
Submission requirements for the other Committee members: After validation of the application, the Agency will notify both the applicant and the (co-)rapporteurs accordingly in writing. After that, the applicant should forthwith send the application as well as all additional submitted information to the members of other Committees (i.e. Pharmacovigilance Risk Assessment Committee, PRAC, or the Committee for Advanced Therapies, CAT). For this, EMA's Guideline entitled "Dossier requirements for Centrally Authorised Products (CAPs)" from 5 November 2013 has to be considered.