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May I ask if the specifications of the original drug equivalent to TE have not changed after re-evaluation, do we still need to submit TE again?
Agrochemicals
Dec. 19th, 2023
After the EU TE evaluation is passed, the active substance is re-evaluated, but the specifications have not changed, in this case, TE is still valid and does not need to be submitted for re-evaluation. However, it is actually more difficult for enterprises to judge whether the specifications have changed by themselves. Because the specification of the

  After the EU TE evaluation is passed, the active substance is re-evaluated, but the specifications have not changed, in this case, TE is still valid and does not need to be submitted for re-evaluation. However, it is actually more difficult for enterprises to judge whether the specifications have changed by themselves. Because the specification of the active substance is not fully disclosed. In this case, the RMS (Evaluation Member State) of the active substance rereview can be contacted to confirm whether the specification has changed.

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