Completeness check of the dossier
Article 5
1. Within 30 days of receiving the application, the rapporteur Member State shall check whether the dossiers submitted with the application contain all the elements provided for in Article 4, using the checklist referred to in Article 4(1)(d). 2. Where one or more of the elements provided for in Article 4 are missing, the Member State shall inform the applicant, setting a time period for their submission; such time period shall be no more than six months. 3. Where at the end of the period, referred to in paragraph 2, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant, the Commission and the other Member States. If, after giving the applicant an opportunity to comment, the Commission determines that the applicant has failed to submit the missing elements, it shall adopt a decision providing that the active substance concerned is not to be included in Annex I to Directive 91/414/EEC. Such a decision shall end the assessment of that active substance under this Regulation. 4. A new application for the same substance may be submitted at any time. 5. Where the dossiers submitted with the application contain all the elements provided for in Article 3, the rapporteur Member State shall notify the applicant, the Commission, the other Member States and the Authority of the completeness of the application.