In principle, the permit holder is allowed to add any changes in the work to the permit merely by notifying them, provided that these changes remain within the set framework of the environmental risk assessment. All changes in the permit can be notified, bar the following exceptions:
- the addition of another location;
- if the changes concern an expansion in the number of test subjects that leads to an exceedance of the maximum number of test subjects allowed under the original permit;
- if they concern a change in the end date of the research that leads to an exceedance of the end date in the original permit;
- if the issued permit relates to gene therapy in humans and the changes are not limited to gene therapy in humans;
- if the changes concern an adjustment in the administering method that does not remain limited to tattooing or direct injection into the skin of striated muscle tissue;
- if the changes concern the addition of a viral sequence other than any of the excepted viral sequences;
- if the changes concern the addition of antibiotic-resistant genes, unless these confer resistance solely to kanamycin or neomycin.
The excepted changes may mean that the permit must be adjusted, or that a new permit must be applied for.