Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p50
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 50/476)
Character Range: 1034163–1045709

request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA‑approved Product Information.
Buprenorphine                                                          C16009                                                               Opioid dependence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 16009
                                                                                                                                            The treatment must be within a framework of medical, social and psychological treatment.
                                                                                                                                            The prescriber must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.
                                                                       C16015                                                               Opioid dependence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 16015
                                                                                                                                            Must be treated by a health care professional.
                                                                                                                                            The treatment must be within a framework of medical, social and psychological treatment; AND
                                                                                                                                            Patient must be stabilised on one of the following prior to commencing treatment with this drug for this condition: (i) weekly prolonged release buprenorphine (Buvidal Weekly) (ii) sublingual buprenorphine (iii) buprenorphine/naloxone.
                                                                                                                                            The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs.
                                                                       C16050                                                               Opioid dependence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 16050
                                                                                                                                            Must be treated by a health care professional.
                                                                                                                                            The treatment must be within a framework of medical, social and psychological treatment; AND
                                                                                                                                            Patient must be stabilised on sublingual buprenorphine or buprenorphine/naloxone prior to commencing treatment with this drug for this condition.
                                                                                                                                            The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs.
                                                                       C16051                                                               Opioid dependence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 16051
                                                                                                                                            Must be treated by a health care professional.
                                                                                                                                            The treatment must be within a framework of medical, social and psychological treatment.
                                                                                                                                            The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs.
Buprenorphine with naloxone                                            C16009                                                               Opioid dependence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 16009
                                                                                                                                            The treatment must be within a framework of medical, social and psychological treatment.
                                                                                                                                            The prescriber must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.
Burosumab                                                              C13330                                                               X‑linked hypophosphataemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must