National e-submission guidance

General information on providing e-submissions only 

All e-submissions (any regulatory activity) need to be provided via CESP or CD/DVD.  Only e-submissions on CD/ DVD medium are accepted.
 
E-submissions sent via e-mail or EUDRALINK system are not accepted.

With any e-dossier sequence (submitted via CESP or CD/DVD) validation rapport and working documents (.docx, if applied) need to be provided.
 
No more additional documents (in paper) are not required, except Power of Attorney, originally signed.
 
Should SMCA detect that e-submission contains viruses or other malware, or one or more files on e-submission medium are not readable due to disc burning errors or damaged medium, such submission will not be processed (applicant will receive immediate notice).