Conclusions
A streamlined procedure is now in place in the EU to facilitate a
consistent approach for the assessment of the environmental risks of
medicines containing GMOs. Different countries have different approaches
to this issue, but the risks, and potential harms to the environment and
population at large are weighted in each application.
Following available guidance is essential to avoid questions and delays
at approval time and help the preparation of the environmental risk
assessment necessary in all marketing applications.
With these initiatives regulators are answering the calls to facilitate
research and assessment of the environmental risk aspects of medicines
containing GMOs in Europe.