Division 10.2 Translational and applied research

‘Translational and applied research’ refer to animals used for purposes as described in Article 5(b) and (c) excluding any regulatory use of animals (see point 10.3. below).

This also includes discovery toxicology and investigations to prepare for the regulatory submission and method development. This does not include studies required for regulatory submissions.

The animals used for the creation of a new genetically altered animal line intended to be used for the purposes of translational or applied research (for example, cancer research, vaccine development) shall be recorded according to the purpose they are being created for. In addition, they shall be reported in ‘Creation of a new genetic line – Animals used for the creation of a new genetically altered line/strain’.

All animals carrying the genetic alteration shall be reported during the creation of a new line. Also animals used in creation, such as for superovulation, vasectomy and embryo implantation shall be reported here. The reporting shall exclude non-genetically altered (wild type) offspring.

A new strain or line of genetically altered animals is considered to be ‘established’ where transmission of the genetic alteration is stable, which will be a minimum of two generations, and a welfare assessment has been completed.