Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4390
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4390
Character Range: 2063546–2067346

4390                                      RUTA GRAVEOLENS                                                                          A, E, H   The requirements specified below apply to a medicine that contains the ingredient that is:
                                                                                                                                             - listed in the Register on or after 1 March 2025; or
                                                                                                                                             - released for supply on or after 1 March 2026.
                                                                                                                                             When used as an active ingredient:
                                                                                                                                             (a) Ruta graveolens must only be used as a homoeopathic ingredient;
                                                                                                                                             (b) the routes of administration for medicines that contain Ruta graveolens must be limited to:
                                                                                                                                             (i) topical for dermal use; and
                                                                                                                                             (ii) oral;
                                                                                                                                             (c) when the homoeopathic potency of the medicine containing Ruta graveolens is 12X or lower, the following warning statement is required on the medicine label:
                                                                                                                                             - (NEW) 'Do not use if pregnant or likely to become pregnant, or during lactation.'; and
                                                                                                                                             (d) when the medicine is for dermal use, the following statement is required on the medicine:
                                                                                                                                             - (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect).
                                                                                                                                             When used as an excipient ingredient:
                                                                                                                                             (a) The route of administration for medicines that contain Ruta graveolens must be limited to topical;
                                                                                                                                             (b) Ruta graveolens must only be included in combination with other permitted ingredients as a fragrance proprietary excipient formulation;
                                                                                                                                             (c) the total concentration of fragrance proprietary excipient formulations containing Ruta graveolens must not be more than 1% of the total medicine; and
                                                                                                                                             (d) the total concentration of Ruta graveolens in the medicine must not be more than 0.15%.