Division 2 Efficacy trials carried out in the laboratory shall be controlled trials, including untreated control animals unless this is not justified for animal welfare reasons and efficacy can be otherwise demonstrated.

In general, these laboratory trials shall be supported by trials carried out in field conditions, including untreated control animals.

All trials shall be described in sufficiently precise details so as to be reproducible in controlled trials, carried out at the request of the competent authorities. The investigator shall demonstrate the validity of all the techniques involved.

All results obtained, whether favourable or unfavourable, shall be reported.