Application to the regulatory authorities

Before a clinical trial of medicinal product can start, the trial need an approval from the regulatory authorities (Ethics Committee and Norwegian Medicines Agency (SLV)). A guide to the regulatory authorities and how to apply for approval can be found in the SOP Søknadsprosess, godkjenninger og oppstart (Norwegian).

Required documentation of the medicinal product are described in SOP Dokumentasjon av utprøvningspreparater (Norwegian). Use of the checklist sjekkliste for legemiddelhåndtering (Norwegian) can be helpful.

If the drug/product being tested does not have approval for use, an Investigator’s Brochure (IB) must be included in the submission to the Norwegian Medicines Agency and Ethics Committee. A template can be found in Investigator’s Brochure (IB). Checklist Investigator’s Brochure (Norwegian) to guide the process is provided.