Approvals of biotechnology in human medicine
About this form
Applications must be sent to the Norwegian Directorate of Health.
All enterprises that plan to engage in testing/methods and forms of treatment in the application of biotechnology in human medicine and that apply for approval for the purpose in question.
The purpose of the requirement for approval is to ensure that medical applications of biotechnology are utilised for the benefit of everyone in an inclusive society. This shall be done in accordance with the principles of respect for human dignity, human rights and personal integrity and without any discrimination on the basis of genetic constitution, on the basis of the ethical norms that form part of our Western cultural heritage.
Certain forms of testing and forms of treatment as mentioned in the Biotechnology Act Sections 2-19, 3-3, 4-2, 5-3 and 6-3 may only be utilised by approval. This primarily concerns approval of forms of treatment etc. relating to medically assisted reproduction, approval of examination methods in prenatal diagnosis, approval of genetic testing for each disease / predisposition for a disease and approval of forms of treatment for gene therapy.
Requirements of the applicant:
Pursuant to Section 7-1, the medical application of biotechnology that requires approval pursuant to the above-mentioned provisions may only take place at establishments specifically authorised for the purpose in question. The decision to approve an establishment shall specify which forms of medical biotechnology it is permitted to carry out or commission.
