If the changes have no significant consequences for the environmental risk assessment, the permit may be adjusted via the adjustment procedure.
Each adjustment request is evaluated to see whether the adjustment can be implemented via the adjustment procedure. In practice, the criterion will be that the intended change must have no significant consequences for the environmental risk assessment, or that adjustment of the permit is justified for another reason.
Below are a few indicative examples to give some insight into what changes in most cases have no significant consequences for the environmental risk assessment. It involves, for example:
- A change in the formulation of the preparation, for example adding non-genetically modified organisms in a polyvalent vaccine;
- A change in the number of administrations, the timing of administration and / or dosage of the GMO (Genetically Modified Organism );
- A replacement, addition or removal in the sampling and / or validated analytical methods on samples of subjects following administration;
- A replacement, addition or removal of additional treatment methods , for example, the use of chemotherapy;
- A replacement, addition or removal of marker and reporter genes, for example the use of RFP (red fluorescent protein ) (red fluorescent protein) instead of GFP (green fluorescent protein ) (green fluorescent protein).