Substantial amendments shall be submitted to the NoMA, and the principle of scilent approval is still applicable with the same condition as previously described. 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.
The same procedure 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.