​VHP and VHP+

In order to prepare us for the upcoming regulation, the Norwegian Medicines Agency has been participating in the Voluntary Harmonisation Procedure (VHP and VHP+). The VHP procedure makes it possible to obtain a coordinated scientific assessment of an application for a clinical trial that is to take place in several European countries. VHP plus includes the involvement of Ethics Committees, where they also take part in the assessment.

By taking part in VHP, The Norwegian Medicines Agency and Regional Ethics Committee gain useful experience with coordinated assessments of their clinical trial applications, both nationally and with the other EU member states.

User-testing and training - CTIS

The Norwegian Medicines Agency has also been participating in the user-testing of the new clinical trial platform CTIS. We are also taking part in the EMAs Master Training Programme.

CTR/CTIS Information seminars

The Norwegian Medicines Agency is also planning information meetings in the autumn of 2021 in its major Norwegian cities. Further information will follow.

For further information regarding VHP and VHP+, please see: https://legemiddelverket.no/godkjenning/klinisk-utproving/voluntary-harmonised-procedure-vhp