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Home Authorisation & Approval Marketing authorisation of VMPs eSubmission - Electronic submission of applications
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Written by Leona Nepejchalová   

Vet eSubmission

Vet eSubmission on EMA websites

 

Information for applicants/marketing authorisation holders concerning use of electronic application form


 


ISCVBM informs applicants/marketing authorisation holders that use of the electronic Application Forms (eAF) is mandatory for DCP/MRP from 1 January 2016. The eAFs must be used for all applications: authorisations, variations and renewals.


The implementation is part of the HMA eSubmission roadmap.


The document eSubmission Roadmap is accessible on the following website eSubmission – HMA eSubmission Roadmap - http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html.


The electronic application forms eAF are accessible on the website eSubmission – EU Electronic Application Forms - http://esubmission.ema.europa.eu/eaf/index.html. As from 1 January 2016 it will be available on the Commission website  http://ec.europa.eu/health/documents/eudralex/vol-6/index_en.htm.


The coordination group CMDv emphasized the duty concerning the use of eAF from 1 January 2016 within „Reports for release“.  http://www.hma.eu/fileadmin/dateien/Veterinary_medicines/Reports_for_Release/161115_CMDv_RfR_Sept-Oct_06.11.15.pdf


CMDv has prepared a guide how to use eAF „ User Guide for the Electronic Application Form to help applicants complete the eAF“ that you can find on the following website:


http://www.hma.eu/fileadmin/dateien/Veterinary_medicines/Miscellaneous/030715_AF_user_guide_consolidated_vet_version.pdf


Pure national applications for veterinary MPs in CZ


The use of eAF for new authorisations, variations and renewals applies to national applications too. If applicants do not choose the eAF for their submissions current NTA word versions will be still available on the ISCVBM webiste for such cases. However these old NTA word application forms will not be available on the Commission website any more from 1 January 2016.   


 

Last Updated on Wednesday, 18 October 2017 14:11