(c)the data required for risk management as provided for in Articles 7, 9 and 11 and information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002.’;
(c)paragraph 6 is replaced by the following:‘6.The summary of the dossier referred to in paragraph 1(c) shall include a reasoned statement that the use of the product complies with the conditions laid down in: