Notification of intended studies and advice on intended studies
Article 3
1. Notifications of studies intended to be conducted to support a future application for renewal in accordance with Article 32c(1) of Regulation (EC) No 178/2002 shall be submitted sufficiently ahead of the date for submission of the application for renewal in accordance with Article 5(1) of this Regulation in order to allow public consultation to be performed and comprehensive advice to be provided by the Authority and the studies required in support of a future application for renewal to be carried out in a timely and proper manner. 2. The pre-submission advice by the Authority pursuant to Article 32c(1) of Regulation (EC) No 178/2002 shall be provided with the participation of the rapporteur Member State and the co-rapporteur Member State, taking into account any existing experience and knowledge relevant for the active substance, including, where appropriate, available studies from the earlier approval or renewal of approval.