Article 7
Submission of dossiers 1. The notifier(s) shall submit to the relevant rapporteur Member State the summary dossier referred to in paragraph 2 and the complete dossier referred to in paragraph 3, by 30 November 2003 at the latest for active substances listed in Annex I, part A, and by 30 November 2004 at the latest for active substances listed in Annex I, part B. Where for any active substance listed in Annex I there are several notifications, the notifiers concerned shall take all reasonable steps to submit these dossiers collectively. Where a dossier is not submitted by all notifiers concerned, it shall mention the efforts made and the reasons why certain notifiers have not participated. For active substances notified by more than one notifier, those notifiers shall for each study involving vertebrate animals, detail the attempts made to avoid duplication of testing and give, if applicable, the reasons for conducting a duplicate study. 2. The summary dossier shall include the following: (a) a copy of the notification; in the case of a joint application made by several producers, a copy of the notifications made in accordance with Article 10 of Regulation (EC) No 451/2000 and the name of the person designated by the producers concerned as being responsible for the joint dossier and the processing of the dossier in accordance with this Regulation; (b) a limited range of representative uses of the active substance, in respect of which the data submitted by the notifier in the dossier shall demonstrate that for one or more preparations, the requirements set out in Article 5 of Directive 91/414/EEC for inclusion of the active substance in Annex I to Directive 91/414/EEC, can be met; (c) (i) for each point of Annex II to Directive 91/414/EEC, the summaries and results of studies and trials, the name of the person or institute that has carried out the trials; (ii) for each point of Annex III to Directive 91/414/EEC the summaries and results of studies and trials, the name of the person or institute that has carried out the trials, relevant to the assessment of the criteria referred to in Article 5 of Directive 91/414/EEC for one or more preparations which are representative for the uses referred to in subparagraph (b) taking into account that data gaps in the information of the Annex II dossier resulting from the proposed limited range of representative uses of the active substance may lead to restrictions in the inclusion into Annex I to Directive 91/414/EEC; (iii) and for active substances listed in Annex I, part B, for studies not yet fully completed the evidence that these studies have been commissioned as required by Article 10(4) of Regulation (EC) No 451/2000 with an undertaking that they will be submitted at the latest by 31 May 2005; (d) a checklist to be filled in by the notifier, demonstrating that the dossier is complete. 3. The complete dossier shall physically contain the individual test and study reports concerning all the information referred to in paragraph 2(c), or the evidence referred to in paragraph 2(c)(iii) where work is in progress. 4. Each Member State shall define the number of copies and the format of the summary and the complete dossiers to be submitted by the notifiers. In defining the format of the dossier Member States shall take account of the recommendations made in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC. 5. Where the dossiers or any part of them are not sent within the relevant time limit, the rapporteur Member State shall inform the Commission and the EFSA within two months, giving any justification for the delay provided by the notifiers. 6. On the basis of the information transmitted by the rapporteur Member State in accordance with paragraph 5, the Commission shall determine whether the notifier has demonstrated that the delay in submission of the dossier was caused by force majeure. In this case, it shall establish a new time limit for the submission of a dossier fulfilling the requirements of paragraphs 2 and 3 in accordance with the procedure provided for in Article 19 of Directive 91/414/EEC. 7. The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include in Annex I to Directive 91/414/EEC an active substance for which no dossier has been submitted within the established time limit.