Application for authorisation of a new substance
Article 9
1. To obtain the authorisation referred to in Article 8(1), the following procedure shall apply: (a) an application shall be submitted to the competent authority of a Member State accompanied by the following: (i) the name and address of the applicant; (ii) a technical dossier containing the information specified in the guidelines for the safety assessment of a substance to be published by the Authority; (iii) a summary of the technical dossier; (b) the competent authority referred to in (a) shall: (i) acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement shall state the date of receipt of the application; (ii) inform the Authority without delay; and (iii) make the application and any supplementary information supplied by the applicant available to the Authority; (c) the Authority shall without delay inform the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them. 2. The Authority shall publish detailed guidelines concerning the preparation and the submission of the application ( 11 ) .