Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:2
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 2
Character Range: 87561–88761

2                                                                           A change to the synthesis of an active pharmaceutical ingredient of the medicine if:                                                                                                                                                                       ACEP
                                                                            (a) the ingredient is not a synthetic polypeptide; and
                                                                            (b) the ingredient is not prepared by fermentation; and
                                                                            (c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and
                                                                            (d) the Directorate:
                                                                            (i) has issued a revised certificate of suitability in relation to the ingredient; or
                                                                            (ii) has declared that the ingredient does not require a revised certificate of suitability