Plant Protection – Fast track approval for products with new Active Substance under Article 37(3)

For an application for authorisation of a new plant protection product containing a new active substance, a kind of fast-track procedure exists.

If the application for authorization of such a plant protection product concerns the same plant protection product as described in the active substance dossier (so called representative formulation) and the application for authorization concerns the same uses (GAP) as described in the active substance dossier, the Member State examining the application shall start the evaluation as soon as it has received the draft assessment report for the active substance approval.

In this case, the Member State shall decide on the application at the latest within six months of the active substance being approved, reducing the authorization period to a maximum of 6 months.