General Conditions for evaluations of dossiers
Article 15
1. Without prejudice to Article 18 the rapporteur Member State shall evaluate all dossiers submitted to it. 2. Without prejudice to Article 7 of Directive 91/414/EEC, the rapporteur Member State shall not accept the submission of new studies during the evaluation except as provided for in Article 9 (1)(c) of this Regulation. However, the rapporteur Member State may request the notifier to submit further data which are necessary to clarify the dossier. When doing so the rapporteur Member State shall set a time limit within which the information shall be provided. The time limit shall not affect the time limit for the submission of the draft assessment report by the rapporteur Member State to the EFSA as provided for in Article 21(1) or Article 22(1). 3. The rapporteur Member State may, from the start of the evaluation of the dossier: (a) consult with experts from the EFSA; (b) request additional technical or scientific information from other Member States to assist in the evaluation. 4. Notifiers may seek specific advice from the rapporteur Member State.