Format and content of application
Article 5
1. An application shall be submitted in the format set out in Annex II. 2. The application shall state which sections of the dossiers submitted for the first inclusion of the active substance require updating with new information. Hereinafter, that part of the application is referred to as ‘the updating statement’. 3. The updating statement shall list the new information the applicant intends to submit and demonstrate that such information is necessary, because of data requirements or criteria which were not applicable at the time of the first inclusion of the active substance or because of changes in the representative uses or because the application is for an amended renewal. The updating statement shall separately list new studies the applicant intends to submit on vertebrate animals. 4. Upon request from any interested party, the rapporteur Member State shall make available the information listed by the applicant as referred to in paragraph 3.