Clinical Trial Application for GMO Medicinal Products for Humans

• Information as provided under §15 of the Regulation on Environmental Impact Assessment under the Gene Technology Act (hereinafter referred to as the EIA-regulations), Annex 1 part A. 
• Health and Environmental Risk Assessment with conclusions following the requirements in Annex 2 of the EIA-regulations. 
• Documentation and assessment of ethical soundness, societal benefit value, and impact on sustainable development. Further guidance can be found under Annex 4 of the EIA-regulations. 
• Documentation supporting the applicant's Environmental Impact Assessment of the GMO's properties. This may include results from previous trials (raw data) and/or scientific literature. 
• SNIF (Summary Notification Information Format), a concise summary of the application without confidential information. SNIF can be submitted either in word or PDF format. In addition, the applicant must also upload SNIF in the EU database for GMO applications – E-submission Food Chain platform (ESFC).  If you require further assistance with the platform you can find a user manual as well as background information for using this platform, please see the EU commissions webpage for Training and support. SNIF is made publicly available on the consultation page. 

Clinical Trials with Human Genetically Modified Cells

If the application concerns a clinical trial with human cells that are modified with retro-, lenti-, or adeno-associated virus vector, where the medicinal product has a documented negligible level of free virus particles, the application form developed in the EU can be used: Common Application form for clinical research with human cells genetically modified.

Related guidance document: Good Practice on the assessment of GMO-related aspects in the context of clinical trials with human cells genetically modified.

The application form provides sufficient information to conduct an environmental risk assessment as well as an assessment of sustainability, societal benefit, and ethical soundness in accordance with the requirements as laid out in Section 10 of the Gene Technology Act. We therefore do not require the applicant to submit a separate assessment for these aspects.

The application shall contain a completed application form as described above, and attachments as described in the form. Confidential information and SNIF must be attached to the application.

Clinical Trials Where the Investigational Medicinal Product Consists of or Contains Adeno-Associated Viruses

If the application concerns these products, the following application form developed in the EU can be used: Common application form for investigational medicinal products for human use that contain or consist of AAV vectors

Related guidance document: Good Practice on the assessment of GMO-related aspects in the context of clinical trials with AAV clinical vectors

The application form provides sufficient information to conduct an environmental risk assessment as well as an assessment of sustainability, societal benefit, and ethical soundness in accordance with the requirements as laid out in Section 10 of the Gene Technology Act. We therefore do not require the applicant to submit a separate assessment for these aspects.

The application shall contain a completed application form as described above, and attachments as described in the form. Confidential information and SNIF must be attached to the application.

General Information

The Norwegian Directorate of Health shall assess whether the rules for contained use of GMO apply. In some cases, the handling of the Gene Therapy Product (and the GMO) up until it is given to the patient should be assessed under the Regulations for contained use of GMO. The Directorate of Health requires a description of the GMO, which should cover the following aspects: 

• whether the GMO is a genetically modified virus, bacteria, or cells in culture (which type),
• whether the GMO can replicate or not,
• and whether the GMO can transfer genetic material, etc. 

For further information, see the Directorate of Health's webpage.

If the rules on the contained use of GMO are applied, the company conducting the trial must have approved laboratories and facilities for contained use of GMO. See the information page about the Gene Technology Act.

All clinical trial applications including accompanying documentation for medicinal products containing GMO should be sent to GMO@dmp.no.
The decision-making authority for import and transport of GMO under the regulation for labelling, transport, import, and export of Genetically Modified Organisms is the Norwegian Environment Agency. The regulation provides an overview of which GMOs require approval under this regulation. This application can also be sent to GMO@dmp.no. This only applies to applications concerning Investigational Medicinal Products. NOMA will forward the application to the Norwegian Environment Agency, when received. For further information please see the Norwegian Environment Agency's webpage.

GMO@dmp.no is a joint mailbox for the Norwegian Environment Agency, the Norwegian Directorate of Health, and Norwegian Directorate for Medicinal Products for applications for the approval of clinical trials with investigational medicinal products containing genetically modified organisms.

The assessment in accordance with the Gene Technology Act will be sent at the same time as the assessment of the clinical trial. The first assessment is normally available within 45 days after receipt of the application.