Article 4Completeness check of the dossiers

1.

Within 3 months from receiving the application, the rapporteur Member State shall check whether the dossiers submitted with the application contain all the elements provided for in Article 3, using the checklist referred to in Article 3(1)(d). It shall also check the requests for confidentiality referred to in Article 2(2) and the list of tests and studies submitted pursuant to Article 3(2).

2.

Where one or more of the elements provided for in Article 3 are missing, the rapporteur Member State shall inform the applicant, setting a time period for their submission; such time period shall be no more than 3 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 that the application is rejected.

4.

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 European Food Safety Authority, hereinafter ‘the Authority’, of the completeness of the application. After receiving that notification, the applicant shall immediately forward those dossiers to the other Member States, the Commission and the Authority, including the information about those parts of the dossiers in respect of which confidentiality has been requested as referred to in Article 2(2).

5.

Within 4 months from the date of receipt of the notification referred to in paragraph 4, a decision shall be adopted in accordance with Article 6(3) of Directive 91/414/EEC establishing that the dossiers submitted fulfil the requirements of Annexes II and III to that Directive, hereinafter ‘completeness decision’.