CHAPTER IVEVALUATIONS OF DOSSIERS
Article 24dF1Submission of additional information after the draft assessment report has been submitted to the EFSA
1
Without prejudice to Article 7 of Directive 91/414/EEC submission of new studies shall not be accepted.
2
Where the EFSA considers that additional information from the notifier is necessary to comply with a request made by the Commission under Article 24c, the rapporteur Member State shall request that information. Such requests shall be made explicitly and in writing, setting a time period for submission of one month. They shall not concern the submission of new studies. The rapporteur Member State shall inform the Commission and the EFSA of such requests in writing.
The rapporteur Member State shall, within one month after the receipt of such information, evaluate the information received and send its evaluation to the EFSA.
3
Information submitted by the notifier but which has not been requested, or which has not been submitted before the end of the time period referred to in paragraph 2, shall not be taken into account unless this information has been submitted in accordance with Article 7 of Directive 91/414/EEC.
Where the rapporteur Member State, pursuant to paragraph 1 or to the first subparagraph of this paragraph, refuses to take into account studies or information received from the notifier, it shall inform the Commission and the EFSA and indicate the reasons for such refusal.