Principles for extrapolation
Article 3
The EMA shall consider the extrapolation of MRLs where there is MRL or ‘No MRL required’ status established for the pharmacologically active substance and one of the following circumstances applies to the concerned species: (1) It is related to a major reference species for which MRLs have been established or a ‘No MRL required’ status exists for the concerned tissue/food commodity; (2) It is related to a minor reference species for which MRLs have been established or a ‘No MRL required’ status exists for the concerned tissue/food commodity; (3) It is unrelated to the reference species for which MRLs have been established or a ‘No MRL required’ status exists for the concerned tissue/food commodity; (4) MRL has been established for the concerned species but not for the concerned tissue/food commodity.