Article 10
Notification 1. Any producer wishing to secure the inclusion of an active substance referred to in Annex II to this Regulation, in Annex I to the Directive shall so notify the body referred to in Annex VII to this Regulation. The Commission shall give regular follow-up of the tasks mentioned in Annex VII to this Regulation entrusted to the body referred to in that Annex. In accordance with the procedure laid down in Article 19 of the Directive it may be decided to designate another body if it appears that the tasks are not adequately performed. 2. Notifications shall be submitted for each active substance separately, as follows: (a) within three months of the date of entry into force of this Regulation, a first notification in accordance with Section 1 of the model notification as shown in Annex IV, Part 2 hereto; and (b) within nine months of the date of entry into force of this Regulation, a second notification in accordance with Sections 1 and 2 of the model notification as shown in Annex IV, Part 2 hereto, including a written commitment to present a complete dossier. 3. Detailed provisions concerning the submission of such dossiers, the time limit(s) for their submission and the fee regime for the active substances concerned shall be established by the Commission in a Regulation to be adopted in accordance with Article 8(2), second subparagraph, of the Directive. 4. The time limit for the submission of a full data package shall be 25 May 2003 at the latest. The full data package shall contain physically the individual test and study reports concerning all the information referred to in Article 6(2)(c), first and second indents. Nevertheless, in the Regulation referred to in paragraph 3, a later time limit may be established in exceptional cases for the results of long-term studies, not expected to be fully completed by that date, provided that the data package contains: - evidence that such studies have been commissioned at the latest within 12 months of the date of the entry into force of this Regulation, - a due scientific justification, - the protocol and a progress report of the study. 5. Any producer who has not notified any given active substance referred to in paragraph 1 within the time limits referred to in paragraph 2 or whose notification was rejected in accordance with Article 11 will be permitted to participate in the review programme only collectively with one or more notifiers of the active substance, whose notification was considered admissible in accordance with Article 11, in submitting a joint dossier.