If the Ethics Committee has approved the application, and the Norwegian Medicines Agency does not oppose amendments 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). This provisional change came into force on February 2 2011 and will apply until a message is published on our web page.

NoMA has until recently responded to all applications for substantial amendments on clinical trials and approved or denied these. However, due to lack of resources and increasing backlogs, we have decided to temporarily change our practice from February 2. From that day the procedure will be as follows:

Substantial amendments shall still be submitted to the NoMA.

If the Ethics Committee has approved the application, and the Norwegian Medicines Agency does not oppose amendments within 35 days of receiving a valid application, sponsor may implement the changes. The substantial amendment is considered approved if the NoMA has not responded within 35 days. The same prosedure will be followed for Voluntary Harmonised Prosedures (VHPs). Substantial amendments in VHP are considered approved if the NoMA has not responded within 7 days.

Day 0 is considered to be the day after the amendment is submitted (by regular mail or by e-mail) to the NoMA.

An invoice will be sent to the Sponsor only in the cases when the NoMA returns a written response to the request for a substantial amendment.

This practice will be in force until a new message is published on NoMA´s website.

Publisert: 27.06.2016