CAAmendment object

Notification mandatory for

Amendments which require a favourable opinion by the EC only

Authorisation mandatory for

Any substantial amendments

Responsible for submission of SA

Sponsor

Timeline for approval of SA (max nr days)

35

Guidance on submission of SA

A request for authorization (including the reasons for the amendments) shall be submitted electronically as indicated on the MPA website in section: Medicinal Products > Practical guidance for submissions

Applicable national legal framework/ Reference

Chapter 6 (1&2) LVFS 2003:6

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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