Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_1057
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 1057
Character Range: 520431–522095

1057                                      CALANUS FINMARCHICUS OIL                                                                         A         Only to be used in a medicine where Blackmores Ltd (Client ID 10576), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 1 March 2025.
                                                                                                                                                     The route of administration for medicines that contain Calanus finmarchicus oil must be limited to oral.
                                                                                                                                                     The maximum recommended daily dose of the medicine must not provide more than 2.3 g of Calanus finmarchicus oil.
                                                                                                                                                     The following warning statements (or words to that effect) are required on the medicine label:
                                                                                                                                                     - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and
                                                                                                                                                     - (ADULT) 'Adults only'.