Invitation to sign an agreement on the documentation submission via CESP

Invitation to sign an agreement on the documentation submission via CESP

The State Agency of Medicines (SAM) invites Marketing Authorisation Holders to sign a mutual agreement on the acceptance of documentation submission via Common European Submission Platform (CESP) without an original signature. It will allow submission of documents for marketing authorisation, renewal and variations of the medicinal products using CESP without the submission of an originally signed cover letter and application form in parallel. It will also lower administrative burdens and simplify circulation of documentation. Please read more about this option on the SAM website section eSubmission/CESP.