Requirements for the impact assessment are provided in Regulations relating to impact assessment pursuant to the Gene Technology Act. The application must comply with section 15 of the Regulation.
An application should include:
- Information according to appendix 1, part A, pursuant to Regulations relating to impact assessment pursuant to the Gene Technology Act.
- Environmental Risk Assessment (ERA) with conclusions must comply with the requirements described in appendix 2.
- For GMO-MPs that contain or consist of genetically modified viral vectors, an assessment of the evaluation of ethical considerations, sustainability, and benefit to society of the GMO is necessary. Guidance can be found in appendix 4.
- Documentation that substantiates the impact assessment of the GMO from preliminary studies (raw data), scientific literature (the list is not exhaustive).
- SNIF (Summary Notification Information Format), short summary of the application not containing confidential information. This document will be published on our web pages as part of the public consultation.
Application for clinical trials with human cells genetically modified by means of lenti/retro- or adeno associated viral vectors
For clinical trials with human cells genetically modified by means of lenti/retro- or adeno associated viral vectors, where the medicinal product has a documented negligible level of free virus particles, a common EU-application form can be used:
The application form can be used in most European countries (23 countries). It is considered that the completed application form provides sufficient information to undertake both a health - and environmental risk assessment, as well as an evaluation of ethical considerations, sustainability, and benefit to society of the GMO, pursuant to the Gene Technology Act section 10. It is therefore not required that the applicant submits a separate assessment of the evaluation of ethical considerations, sustainability and benefit to society.
A case processing time of around 45 working days is calculated, including the public consultation and a health- and environmental risk assessment from VKM.
In addition to the application form the following must be submitted:
- The application form and the good practice document describes how the applicant should document a negligible level of free virus particles. This documentation can be provided in an annex.
- Any confidential information should be provided in an annex, as described in the application form
- SNIF (Summary Notification Information Format), short summary of the application not containing confidential information. This document will be published on our web pages as part of the public consultation.
Application for clinical trials in accordance with requirements laid down in Directive 2001/18/EC
There is no community procedure for approval of GMOs in medicinal products under Directive 2001/18/EC in the EEA countries. An approval must therefore be obtained in each country the clinical trial is to be carried out. However, if you have or are planning to submit an application to another EU / EEA country (applicable to part B applications under Directive 2001/18/EC), then this application can also be used to seek approval pursuant to the Gene Technology Act in Norway.
In addition to the application the following must be submitted:
- An assessment of the evaluation of ethical considerations, sustainability and benefit to society of the GMO
- Documentation that substantiates the impact assessment of the GMO from preliminary studies (raw data), scientific literature (the list is not exhaustive).
- SNIF (Summary Notification Information Format), short summary of the application not containing confidential information. This document will be published on our web pages as part of the public consultation.
Import of GMO-MPs for research purposes
GMO-MPs to be imported for clinical trials may need necessary approval for import and transport in accordance with regulation "forskrift om merking, transport, import og eksport av genmodifiserte organismer". For further advice, please see guidance (in Norwegian):