The Norwegian Medicines Agency (SLV) – clinical guidance

The Norwegian Medicines Agency website contains useful information on how to apply for clinical trials, including associated regulations and guidance.

If you need to apply to conduct a trial in multiple EU/EEA countries, the Voluntary Harmonised Procedure (VHP) can be used to obtain a combined assessment from the various medicines agencies.

From September 2020, VHP+ has been initiated as a trial scheme to practise an overall assessment from ethics committees and medicines agencies. It can be used for clinical trials of medicinal products to be conducted in two or more EU/EEA countries. It should be preferred over VHP.

The actual approval of the trial still takes place in each individual country, and it is therefore not a centralised approval. If agreement is reached in the VHP assessment, the scientific content of the application must not be changed when submitting to the national authorities, but the application can be adapted to any national requirements. Electronic documents can be sent to a single address (one-stop shop).