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Direct links to the current provisions in National Health (Pharmaceutical Benefits) Regulations 1960.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
These Regulations are the National Health (Pharmaceutical Benefits) Regulations 1960.
These Regulations shall come into operation on 1 March 1960.
(1) In these Regulations, unless the contrary intention appears:
applicable amount has the same meaning as in Part VII of the Act.
approved electronic communication means an electronic communication of a kind approved in writing by the Secretary under regulation 5E for the purposes of the provision in which the expression is used.
approved hospital means a hospital in respect of which the hospital authority is approved under section 94 of the Act.
approved hospital authority has the meaning given by subsection 84(1) of the Act.
approved information technology requirements means information technology requirements of a kind approved in writing by the Secretary under regulation 5F for the purposes of the provision in which the expression is used.
approved medical practitioner means a medical practitioner approved under section 92 of the Act.
approved pharmacist has the meaning given by subsection 84(1) of the Act.
Note: The definition in subsection 84(1) of the Act provides that approved pharmacist means a person for the time being approved under section 90 of the Act and includes certain other persons described in that definition. Under paragraph 91(7)(a) of the Act, a person granted permission to supply pharmaceutical benefits under subsection 91(1) of the Act is to be treated as if the person is approved under section 90 of the Act as an approved pharmacist. Under paragraph 91(7)(c) of the Act, references in the Act to an approval granted under section 90 of the Act include references to an approval treated as having been granted under section 90 by paragraph 91(7)(a) of the Act.
approved supplier has the same meaning as in Part VII of the Act.
authorised midwife has the meaning given by subsection 84(1) of the Act.
authorised nurse practitioner has the meaning given by subsection 84(1) of the Act.
authorised optometrist has the meaning given by subsection 84(1) of the Act.
authority prescription means a prescription that prescribes a pharmaceutical benefit and that has been authorised:
(a) in accordance with subregulation 13(5); or
(b) in accordance with authority required procedures that:
(i) are part of the circumstances determined by the Minister under paragraph 85(7)(b) of the Act for the pharmaceutical benefit; or
(ii) are part of the conditions determined by the Minister under subsection 85A(2A) of the Act for the pharmaceutical benefit; or
(iii) are incorporated by reference into the circumstances determined for the pharmaceutical benefit under subsection 85B(4) of the Act.
brand, for a pharmaceutical item, means a brand of the pharmaceutical item within the meaning of subsection 84(1) of the Act.
Commonwealth price has the same meaning as in Part VII of the Act.
concessional beneficiary has the same meaning as in Part VII of the Act.
concession card has the same meaning as in Part VII of the Act.
CTS claim has the meaning given by subsection 84(1) of the Act.
data collection period, for a brand of a pharmaceutical item: see regulation 37C.
deferred supply authorisation means a deferred supply authorisation prepared under paragraph 26A(2)(a).
delisted brand, of a pharmaceutical item: a listed brand of a pharmaceutical item becomes a delisted brand when a determination made under subsection 85(6) of the Act is no longer in force for that brand.
dependant, in relation to a concessional beneficiary, has the same meaning as in Part VII of the Act.
drug in a pharmaceutical item has the same meaning as in Part VII of the Act.
electronic communication has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999.
electronic order form means a form that is approved in writing by the Secretary under subparagraph 16(1)(b)(ii) for the purposes of lodging an order under paragraph 16(1)(b).
electronic prescription means a prescription that is prepared and submitted:
(a) in accordance with approved information technology requirements (if any), by means of an approved electronic communication; and
(b) in accordance with the appropriate form under:
(i) sub‑subparagraph 19(1)(a)(iia)(B) (prescriptions other than medication chart prescriptions); or
(ii) subregulation 19AA(5) (medication chart prescriptions).
entitlement card has the same meaning as in Part VII of the Act.
final day, in relation to a data collection period, means the last day of the data collection period.
incentive, for a brand of a pharmaceutical item, includes anything given as an incentive to take supply of the brand (including a delisted brand before it was delisted) whether the incentive is given:
(a) before the supply of the brand, but on condition of taking supply; or
(b) at, or after, the time of the supply of the brand; or
(c) over a period of time; or
(d) directly for the brand; or
(e) indirectly for the brand (for a group of brands of pharmaceutical items or other products, for example).
information technology requirements has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999.
initial month, for a brand of a pharmaceutical item that was not a listed brand immediately before the brand’s start day, means the first month of the brand’s first data collection period.
last listed brand, of a pharmaceutical item, means the brand of the pharmaceutical item that was the last to become a delisted brand before the final day.
Medicare Australia/DVA copy, for a paper‑based prescription, means the duplicate of the prescription on which appear the words ‘Medicare Australia/DVA copy’.
medicare number has the same meaning as in Part VII of the Act.
medication chart has the meaning given by subregulation 19AA(4).
medication chart prescription has the meaning given by subregulation 19AA(1).
optometrist has the meaning given by subsection 84(1) of the Act.
out‑patient medication has the same meaning as in Part VII of the Act.
paper‑based prescription means a prescription that is prepared in duplicate in accordance with subparagraph 19(1)(a)(i), (ii) or (iii).
participating dental practitioner has the same meaning as in Part VII of the Act.
PBS prescriber has the meaning given by subsection 84(1) of the Act.
pharmaceutical benefit has the same meaning as in Part VII of the Act.
pharmaceutical item has the same meaning as in Part VII of the Act.
pharmaceutical item has a drug has the same meaning as in Part VII of the Act.
pharmacist/patient copy, for a paper‑based prescription, means the original of the prescription on which appear the words ‘pharmacist/patient copy’.
price adjustment means an adjustment under:
(a) a price agreement; or
(b) a price determination; or
(c) Division 3A of Part VII of the Act.
price sampling day: see regulation 37D.
public hospital has the same meaning as in Part VII of the Act.
public hospital authority has the same meaning as in Part VII of the Act.
ready‑prepared pharmaceutical benefit means a pharmaceutical benefit in respect of which a determination made under subsection 85(6) of the Act is in force.
record form has the same meaning as in Part VII of the Act.
related brand, of a brand of a pharmaceutical item, means a brand of a pharmaceutical item that has the same drug and manner of administration as the first pharmaceutical item (including another brand of the same pharmaceutical item), but does not include a brand of an exempt item.
Note: For the definition of exempt item, see subsection 84(1) of the Act.
relevant entitlement period has the same meaning as in Part VII of the Act.
repatriation pharmaceutical benefit has the same meaning as in Part VII of the Act.
repeat authorisation means a repeat authorisation prepared under subparagraph 26(1A)(a)(i).
repeat authorisation form means the form mentioned in subparagraph 26 (1A)(a)(i).
residential care has the meaning given by section 41–3 of the Aged Care Act 1997.
residential care service has the same meaning as in the Aged Care Act 1997.
responsible person has the same meaning as in Part VII of the Act.
special patient contribution has the same meaning as in Part VII of the Act.
start day, for a brand of a pharmaceutical item, means the day on which the brand was first required to comply with the price disclosure requirements under section 99ADD of the Act.
the Act means the National Health Act 1953.
(2) In these Regulations, unless the contrary intention appears, a reference to prescribing or to the writing of a prescription shall be read as a reference to the writing of a prescription for the supply of a pharmaceutical benefit under Part VII of the Act. (3) In these Regulations, unless the contrary intention appears: (a) a reference to the holder of a concession card or an entitlement card shall be read as a reference to a person who is, by virtue of section 84G of the Act, to be taken to be a holder of the card; (aa) a reference to the original holder of a concession card is a reference to the person to whom a concession card has been issued under section 84DA of the Act; (b) a reference to the original holder of an entitlement card shall be read as a reference to the person to whom an entitlement card has been issued under section 84E of the Act; and (c) a reference to a member of the family of a person shall be read as a reference to a person who is a member of that family within the meaning of section 84B of the Act.
A reference in these Regulations to writing or preparing a prescription, a repeat authorisation or a deferred supply authorisation, whether the expression writing, preparing or any other expression is used, is taken to include: (a) for an electronic prescription—writing or preparing the prescription by means of an electronic form approved by the Secretary under sub‑subparagraph 19(1)(a)(iia)(B) or subregulation 19AA(5) for the purposes of writing an electronic prescription; and (b) for a repeat authorisation that relates to an electronic prescription—writing or preparing the authorisation by means of an electronic form authorised by the Secretary under subparagraph 26(1A)(a)(i) for the supply of a pharmaceutical benefit under an electronic prescription; and (c) for a deferred supply authorisation that relates to an electronic prescription—writing or preparing the authorisation by means of an electronic form authorised by the Secretary under paragraph 26A(2)(a) for deferring the supply of a pharmaceutical benefit under an electronic prescription.
A reference in these Regulations to the day or date on which a prescription is written by a PBS prescriber or the day or date on which a pharmaceutical benefit is prescribed is, in relation to an electronic prescription, the day or date on which the prescription is signed by the PBS prescriber.
(1) If, under these Regulations, a person is required to write information on a prescription, a repeat authorisation, a deferred supply authorisation or an order form, that requirement is taken to have been met in relation to an electronic prescription, an authorisation that relates to an electronic prescription or an electronic order form, if the person gives the information: (a) in accordance with approved information technology requirements (if any); and (b) by means of an approved electronic communication. (2) This regulation applies to a requirement to write information on a prescription, a repeat authorisation, a deferred supply authorisation or an order form, whether the expression write, certify, endorse, identify, indicate, mark, specify, state, or any other expression is used.
If, under these Regulations, a prescription is required to be given or presented to an approved supplier for the purpose of supplying a pharmaceutical benefit to the person for whom the prescription was written, that requirement is taken to have been met in relation to an electronic prescription if: (a) the person who will receive the pharmaceutical benefit (whether or not for the person’s own use) requests the approved supplier to supply the pharmaceutical benefit; and (b) the approved supplier consents, within the meaning of subsection 5(1) of the Electronic Transactions Act 1999, to the prescription being given or presented, in accordance with approved information technology requirements (if any), by means of an approved electronic communication; and (c) the prescription is accessible by the approved supplier.
The Secretary may, in writing, approve a kind of electronic communication for 1 or more of the following purposes: (a) preparing or submitting an electronic prescription; (b) giving information, for the purposes of these Regulations, in relation to an electronic prescription, an authorisation that relates to an electronic prescription or an electronic order form; (c) giving or presenting an electronic prescription to an approved supplier under these Regulations; (d) submitting an electronic prescription to the Minister in accordance with paragraph 13(3)(b); (e) lodging an order with an approved pharmacist to obtain a pharmaceutical benefit for the purpose of section 93, 93AA or 93AB of the Act; (f) submitting a receipt for a pharmaceutical benefit received under paragraph 16(1)(b); (g) giving an acknowledgment under these Regulations for the supply of a pharmaceutical benefit under an electronic prescription or an authorisation that relates to an electronic prescription; (h) doing any other thing that is required or permitted to be done for the purposes of these Regulations.
The Secretary may, in writing, approve information technology requirements for 1 or more of the following purposes: (a) preparing and submitting an electronic prescription; (b) giving information, for the purposes of these Regulations, in relation to an electronic prescription, an authorisation that relates to an electronic prescription or an electronic order form; (c) giving or presenting an electronic prescription to an approved supplier under these Regulations; (d) lodging an order with an approved pharmacist to obtain a pharmaceutical benefit for the purpose of section 93, 93AA or 93AB of the Act; (e) submitting a receipt for a pharmaceutical benefit received under paragraph 16(1)(b); (f) giving an acknowledgment under these Regulations for the supply of a pharmaceutical benefit under an electronic prescription or an authorisation that relates to an electronic prescription; (g) doing any other thing that is required or permitted to be done for the purposes of these Regulations.
The Minister, in the case of a hospital authority, and the Secretary, in the case of a pharmacist or medical practitioner, may refuse to entertain an application for approval under Part VII of the Act unless the application: (a) in the case of an application for approval of a pharmacist—is in accordance with a form approved in writing by the Secretary; (b) in the case of an application for approva
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