ANNEX

INTRODUCTIONInformation to be submitted, its generation and its presentation

5.Tests on vertebrate animals

5.1.

Tests on vertebrate animals shall be undertaken only where no other validated methods are available. Alternative methods to be considered shall include in vitro methods and in silico methods. Reduction and refinement methods for in vivo testing shall also be encouraged to keep the number of animals used in testing to a minimum.