E-submission

Starting from the 1st of January, 2019, State Medicines Control Agency (SMCA) switches to e-submission (e-dossier) in eCTD  only. All applications for marketing authorization, renewal, all types of variations (under national, decentralized or mutual recognition procedures) need to be submitted as e-dossier via CESP (Common European Submission Portal) or written on CD/DVD. 

To facilitate the administrative processes all regulatory activities (including MAH transfer, Change of local representative, Sunset Clause and etc.) need to be submitted as correspondent eCTD sequence.

If Common Repository for EMA coordinated submissions is used correspondent official cover letter with such information must be sent to SMCA simultaneously.

National e-submission guidance

Usefull links:

• http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html
• https://cespportal.hma.eu/Account/Login?ReturnUrl=%2f
• http://www.hma.eu/277.html
• http://esubmission.ema.europa.eu/ectd/index.html