Specific conditions for submissions of dossiers for active substances listed in Parts B to G of Annex I
Article 10
1. Where the dossier concerns an active substance listed in Part B to G of Annex I, the notifier shall submit a dossier and a summary dossier. 2. The notifier(s) shall include in the summarydossier: (a) the information required under Article 5 and Article 6(2) of this Regulation; (b) for each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive, the summaries and results of tests and studies and the name of the person or institute that has carried out those tests and studies; (c) a checklist to be filled in by the notifier, demonstrating that the dossier is complete in accordance with Article 18 of this Regulation. The tests and studies as referred to in paragraph 2(b) of this Article shall be those relevant to the assessment of the criteria referred to in Article 5 of Directive 91/414/EEC for one or more preparations for the uses taking into account the fact that data gaps in the dossier as regards the information required under Annex II of Directive 91/414/EEC, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the inclusion in Annex I of Directive 91/414/EEC. 3. The complete dossier shall physically contain the individual test and study reports concerning all the information referred to in point (b) and the second subparagraph of paragraph 2. 4. Each Member State shall specify 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 complete and summary dossiers Member States shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.