Article 2U.K.Format and contents of the application
1.The application shall be submitted in the format set out in the Annex.
2.The application shall list the new information the applicant intends to submit. It shall demonstrate that such information is necessary in accordance with the first subparagraph of Article 15(2) of Regulation (EC) No 1107/2009.
The application shall list separately any new studies involving vertebrate animals that the applicant intends to submit.