Article 37(3) 6 months authorization period reduction for the initial product authorization containing a new active substance under approval
Date: 5 June 2020
Reg. (EU) 1107/2009 Article 37 describes the examination period relating to the product authorization procedure. Normally the Member State examining the plant protection product (PPP) application shall decide within 12 months of receiving the application whether the requirements for authorisation are met.
However, for an application for authorisation of a new PPP containing an active substance not yet approved, the Member State examining the PPP application shall start the evaluation as soon as it has received the draft assessment report of the active substance approval referred to in Reg. (EU) 1107/2009 Article 12(1). SCC however recommends submitting the authorization application after the EFSA conclusion of the active substance approval procedure is received, as data points could be modified during the active substance approval procedure, relevant for the authorization of the PPP application.
The following conditions should be fulfilled to qualify for the reduced authorization period procedure:
- The application for authorization concerns the same plant protection product as described in in the active substance dossier referred to in Article 8 (representative formulation)
- The application for authorization concerns the same uses as described in the active substance dossier referred to in Article 8
Furthermore the Member State shall decide on the application at the latest within six months of the active substance being approved, reducing the authorization period with a maximum of 6 months.
Annerie Liebenberg