Application to the authorities

SOP Søknadsprosess, godkjenninger og oppstart (Application process, approvals and start-up)

Necessary documentation of the investigational medicinal products is described in SOP Dokumentasjon av utprøvningspreparater (Documentation of investigational medicinal products). It may be helpful to use a checklist.

If an investigational medicinal product does not have marketing authorisation, an Investigator’s Brochure (IB) must be attached to the application to the Norwegian Medicines Agency and REK. If you receive an IB from another party, e.g. a pharmaceuticals company, you can check that all the points are included (see checklist).