Apply for approval of deliberate release of GMO for use in research

Requirements for approval for deliberate release of GMO for research:

• All clinical trials with medicinal products that contain or consist of GMOs, where the clinical trial subject can leave the contained use facility.

Apply for permission to import and transport GMO

In cases where the GMO-MP is to be imported from abroad it may be necessary to apply for permission for import and transport in accordance with regulation "forskrift om merking, transport, import og eksport av genmodifiserte organismer". In the link below you find an overview for GMOs that require approval for import and transport (in Norwegian):

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):

The Norwegian Environment Agency, The Norwegian Directorate for Health and The Norwegian Medicines Agency have established a common mailbox for applications for approval of medicinal products containing GMO for clinical trials. The Norwegian Medicines Agency operates this mailbox.

All applications for approval to the various authorities should be sent at the same time to this mailbox, to allow the authorities to start the evaluation of the applications at the same time, and in this way facilitate the approval under all regulations before the planned start-up of the clinical trial.

Digital submission

Applications are preferably submitted via Eudralink. It is safe file transfer system managed by the European Medicines Agency, EMA. You can use the system via this link:

The Eudralink is submitted to the shared mailbox:

GMO@legemiddelverket.no

Submission per e-mail

The application can also be submitted directly by e-mail to:

GMO@legemiddelverket.no

Submission of applications by e-mail is at your own risk.

Submission per postal service

If you prefer to send an application by post, it can be sent to the Norwegian Medicines Agency:

Norwegian Medicines Agency
PO Box 240 Skøyen
0213 Oslo, Norway

Label application and documentation with "GMO for deliberate release".

Deadlines

Norwegian authorities shall make a decision within 90 working days of receipt of an application.

Clock-stop

A clock stop is introduced in the case further information is requested from the applicant.

Public consultation

Pursuant to the Gene Technology Act all applications for deliberate release are subject to public consultation. Clinical trials with medicinal products containing or consisting of GMOs, where the clinical trial subject leaves the contained use facility after treatment, are regarded as deliberate release.

Questions related to the application

Questions and inquiries about the application and the application process can be sent to: 

GMO@legemiddelverket.no

The applicant is notified of the outcome of the application through a written decision from the Norwegian Medicines Agency. Any approval will include what the permit comprises, the period of validity of the permit, and may contain terms and conditions related to the deliberate release.

The applicant is obliged to follow up any terms and conditions in the approval and to report on the result of the release. In addition, there are general obligations under the law:

The Norwegian Environment Agency's decision can be appealed to the appeal body, in this case the Ministry of Climate and Environment. This must be done within three weeks from the time the applicant has received notification of the decision. This is in accordance with section 29 of the Public Administration Act.

Complaints are sent to the Norwegian Environment Agency:

• E-mail: post@miljodir.no 
• Postal address: Norwegian Environment Agency, PO Box 5672 Torgarden, 7485 Trondheim, Norway

The Norwegian Environment Agency prepares the complaint and sends it to the Ministry of Climate and Environment.