CAAmendment object

Notification mandatory for

Change of national coordinating investigator; change of sponsor/sponsor's representative; change of sponsor's contact person

Authorisation mandatory for

Any substantial amendments

Responsible for submission of SA

Sponsor

Timeline for approval of SA (max nr days)

35
From date of receipt of valid application
By silent (implicit) approval

Applicable national legal framework/ Reference

Section 5(1) Regulation 2009 for clinical trials

Additional Information

If the Ethics Committee has approved the application, and the Norwegian Medicines Agency does not oppose the amendment within 35 days of receiving a valid application, the sponsor may implement the changes (according to the Norwegian regulation for clinical trials of 30-10-2009, § 5-1). The substantial amendment is considered approved if the NoMA has not responded within 35 days.

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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