Schedule 1 Amendment of Industrial Chemicals (Notification and Assessment) Regulations 1990
(regulation 3)
[1] Subregulation 16 (4)
omit
knowingly or recklessly
Schedule 2 Amendments of National Health (Pharmaceutical Benefits) Regulations 1960
(regulation 4)
[1] Regulation 9
substitute
9 Certain requirements to be met after cancellation etc of approval
(1) If the approval of an approved pharmacist is suspended, revoked or cancelled, the pharmacist must not, in any way, indicate that he or she has been, or is, approved to supply pharmaceutical benefits.
Penalty: 1 penalty unit.
(2) An offence against subregulation (1) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
[2] Regulation 17
substitute
17 Supply of pharmaceutical benefits by chemists for the purposes of section 93
(1) An approved pharmacist commits an offence if:
(a) he or she supplies a pharmaceutical benefit on an order given under regulation 16; and
(b) neither of the following circumstances applies:
(i) the pharmacist knows the medical practitioner whose signature appears on the order;
(ii) if he or she does not know the medical practitioner, the pharmacist:
(A) obtains the full name, address and medical registration number of the medical practitioner from the person who presented the order; and
(B) endorses on the order form the particulars of the medical practitioner mentioned in sub‑subparagraph (A).
Penalty: 0.4 penalty units.
(2) An offence against subregulation (1) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
[3] Regulation 18A
substitute
18A Benefits obtained by approved medical practitioners for the purposes of section 93
(1) An approved medical practitioner commits an offence if he or she obtains a pharmaceutical benefit for the purpose of section 93 of the Act by lodging with an approved pharmacist an order under regulation 16.
Penalty: 0.2 penalty units.
(2) An approved medical practitioner commits an offence if he or she obtains a pharmaceutical benefit for the purpose of section 93 of the Act more than once in each month.
Penalty: 0.2 penalty units.
(3) An approved medical practitioner who obtains a pharmaceutical benefit for the purpose of section 93 of the Act must give a notice to the Secretary that he or she has obtained the benefit.
Penalty: 0.2 penalty units.
(4) For subregulation (3), the notice must be:
(a) in a form authorised by the Secretary; and
(b) signed and dated by the practitioner.
(5) An approved medical practitioner who gives a notice to the Secretary under subregulation (3) must retain a copy of the notice for at least 1 year from the date on which he or she gives the notice to the Secretary.
Penalty: 0.2 penalty units.
(6) An offence against subregulation (1), (2), (3) or (5) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
(7) An approved medical practitioner who:
(a) obtains a pharmaceutical benefit for the purpose of section 93 of the Act in accordance with these Regulations; and
(b) gives a notice to the Secretary under subregulation (3) about the benefit; and
(c) gives the Secretary a claim in accordance with a form made available by the Secretary to approved medical practitioners for that purpose; and
(d) completes the claim form in accordance with directions on that form;
is entitled to payment from the Commonwealth in respect of the pharmaceutical benefit at the rate applicable for the supply of the same benefit on an order under regulation 16.
[4] Regulation 19B
substitute
19B Restriction on using PBS and NHS forms
(1) A person commits an offence if:
(a) he or she writes a prescription on a form bearing the letters ‘PBS’, ‘NHS’ or ‘N. H. S’; and
(b) the prescription is not written in accordance with, or for a purpose authorised by, these Regulations; and
(c) the letters ‘PBS’, ‘NHS’ or ‘N. H. S’ (as the case may be) are not clearly struck out, or obliterated.
Penalty: 0.4 penalty units.
(2) An offence against subregulation (1) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
[5] Subregulation 22 (3), penalty
substitute
Penalty: 0.2 penalty units.
[6] After subregulation 22 (3), including the penalty
insert
(3A) An offence against subregulation (3) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
[7] Subregulation 22 (4), penalty
substitute
Penalty: 0.2 penalty units.
[8] After subregulation 22 (4), including the penalty
insert
(4A) An offence against subregulation (4) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
[9] Subregulation 26 (1)
substitute
(1) Subregulation (1A) applies if:
(a) an approved pharmacist, or an approved medical practitioner, or an approved hospital authority supplies a pharmaceutical benefit under:
(i) an HIC/DVA copy of a prescription that contains a direction to supply the benefit more than once; or
(ii) a pharmacist/patient copy to which is attached a deferred supply authorisation that contains a direction to supply the benefit more than once; or
(iii) a pharmacist/patient copy to which is attached a repeat authorisation that contains a direction to supply the benefit more than once; and
(b) subsequent supplies of the pharmaceutical benefit can be made under the prescription at the time of supply under paragraph (a).
[10] Subregulation 26 (1A), penalty
substitute
Penalty: 0.2 penalty units.
[11] After subregulation 26 (1A), including the penalty
insert
(1B) An offence against subregulation (1A) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
[12] Subregulation 28 (2)
substitute
(2) An approved pharmacist must supply a pharmaceutical benefit as soon as practicable if:
(a) a prescription is presented to the pharmacist under subregulation (1); and
(b) any charge lawfully demanded for the prescription is paid.
Penalty: 0.2 penalty units.
(3) An offence against subregulation (2) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
(4) It is a defence to a prosecution for an offence against subregulation (2) if the pharmacist had a reasonable excuse.
Note A defendant bears an evidential burden in relation to the matter mentioned in subregulation (4) (see section 13.3 of the Criminal Code).
[13] Subregulation 31 (1), at the foot
insert
Penalty: 0.2 penalty units.
[14] Subregulation 31 (2), at the foot
insert
Penalty: 0.2 penalty units.
[15] After subregulation 31 (3), including the penalty
insert
(4) An offence against subregulation (1), (2) or (3) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
[16] Regulation 32
substitute
32 Retention of prescriptions etc
(1) If:
(a) an approved pharmacist, approved medical practitioner, or approved hospital authority supplies a pharmaceutical benefit; and
(b) the benefit supplied is not a dangerous drug within the meaning of regulation 19;
he or she must retain the forms mentioned in subregulation (2) in his or her possession for at least 1 year from the date of supply.
Penalty: 0.2 penalty units.
(2) For subregulation (1), the following forms are specified:
(a) in the case of supply upon a prescription not bearing instructions to supply the pharmaceutical benefit more than once — the pharmacist/patient copy;
(b) in the case of supply upon a prescription bearing instructions to supply the pharmaceutical benefit more than once, if it is supplied on the last occasion on which supply is authorised — the pharmacist/patient copy in respect of which repeat authorisations were issued;
(c) in the case of supply under section 93 of the Act — the duplicate of the order lodged under regulation 16, or the notification form mentioned in regulation 18A, as the case requires.
(3) An offence against subregulation (1) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
[17] Regulation 33
substitute
33 Proper stocks to be kept
(1) An approved pharmacist must, as far as practicable, keep in stock an adequate supply of all drugs and medicinal preparations that he or she may reasonably be expected to be called upon to supply as pharmaceutical benefits, or to use as ingredients of pharmaceutical benefits.
Penalty: 0.2 penalty units.
(2) An offence against subregulation (1) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
[18] Subregulation 37 (2), penalty
substitute
Penalty: 0.2 penalty units.
[19] After subregulation 37 (2), including the penalty
insert
(3) An offence against subregulation (2) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
Schedule 3 Amendments of Therapeutic Goods Regulations 1990
(regulation 5)
[1] Paragraphs (6) (1) (e) and (f)
substitute
(e) that refers to goods, or substances or preparations containing goods, mentioned in Schedule 3, 4 or 8 to the Poisons Standard; or
(f) that are not registered or listed; or
[2] Subregulation 6 (1), penalty
substitute
Penalty: 10 penalty units.
[3] After subregulation 6 (1A)
insert
(1B) For the purposes of an offence under subregulation (1), strict liability applies to the following physical elements:
(a) that the use of a restricted representation has not been approved under subregulation 7C (1) or permitted under subregulation 9 (1);
(b) that the goods, substances or preparations are mentioned in Schedule 3, 4 or 8 to the Poisons Standard;
(c) the elements mentioned in subparagraphs
(1) (g) (i), (ii) and (iii).
Note For strict liability, see section 6.1 of the Criminal Code.
(1C) It is a defence to a prosecution under subregulation (1) if:
(a) in relation to an advertisement mentioned in paragraph (1) (e) — the goods, substances or preparations are mentioned in Appendix H of the Standard; and
(b) in relation to goods mentioned in paragraph (1) (f) — the goods are exempt goods, other than goods of a kind mentioned in paragraph (1) (g).
Note A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1C) (see section 13.3 of the Criminal Code).
[4] Subregulation 6 (2), at the foot
insert
Note A defendant bears a legal burden in relation to the matters mentioned in subregulation (2) (see section 13.4 of the Criminal Code).
[5] Subregulation 6 (5), at the foot
insert
Note A defendant bears a legal burden in relation to the matters mentioned in subregulation (5) (see section 13.4 of the Criminal Code).
[6] Paragraph 9A (1) (a)
substitute
(a) specified in Part 1 of Schedule 10; and
[7] Subregulation 9A (1)
omit
unless the sponsor supplies
insert
if the sponsor does not supply
[8] Subregulation 9A (1), penalty
substitute
Penalty: 10 penalty units.
[9] After subregulation 9A (1), including the penalty
insert
(1AAA) For the purposes of an offence under subregulation (1), strict liability applies to the physical element mentioned in paragraph (1) (a).
Note For strict liability, see section 6.1 of the Criminal Code.
(1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.
Note A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).
[10] Subregulation 9A (1A)
omit
unless the sponsor supplies
insert
if the sponsor does not supply
[11] After subregulation 9A (1A), including the penalty
insert
(1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A) (a).
Note For strict liability, see section 6.1 of the Criminal Code.
[12] After subregulation 9R (2), including the penalty
insert
(2A) For the purposes of an offence under subregulation (1) or (2) in relation to information of a kind mentioned in paragraph (1) (f) or (2) (f), strict liability applies to the physical element that the goods mentioned in that paragraph are not listed in Appendix 5 to the Therapeutic Goods Advertising Code.
Note For strict liability, see section 6.1 of the Criminal Code.
[13] Subregulation 12A (3), penalty
substitute
Penalty: 10 penalty units.
[14] After subregulation 12A (3), including the penalty
insert
(3A) An offence under subregulation (3) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
[15] Subregulation 13 (9), penalty
substitute
Penalty: 5 penalty units.
[16] After subregulation 13 (9), including the penalty
insert
(10) An offence under subregulation (9) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
[17] Subregulation 14 (2), penalty
substitute
Penalty: 5 penalty units.
[18] After subregulation 14 (2), including the penalty
insert
(2A) An offence under subregulation (2) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
[19] Paragraph 32 (1) (b)
omit
by an authorised officer, refuse or fail, without reasonable excuse:
insert
by an authorised officer, fail:
[20] Paragraph 32 (1) (c)
omit
by an official analyst, refuse or fail, without reasonable excuse, to give any information
insert
by an official analyst, fail to give any information
[21] Subregulation 32 (1), penalty
substitute
Penalty: 10 penalty units.
[22] After subregulation 32 (1), including the penalty
insert
(1A) For the purposes of an offence under paragraph (1) (a), strict liability applies to the physical element that the duties mentioned in that paragraph are duties under these Regulations.
Note For strict liability, see section 6.1 of the Criminal Code.
(1B) An offence under paragraph (1) (b) or (c) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
(1C) It is a defence to a prosecution under paragraph (1) (b) or (c) if the person has a reasonable excuse.
Note A defendant bears an evidential burden in relation to the matter mentioned in subregulation (1C) (see section 13.3 of the Criminal Code).
[23] Subregulation 32 (2)
omit
to refuse or fail to comply
insert
to fail to comply
[24] Subregulation 33 (3), penalty
substitute
Penalty: 1 penalty unit.
[25] After subregulation 33 (3), including the penalty
insert
(4) An offence under subregulation (3) is an offence of strict liability.
Note For strict liability, see section 6.1 of the Criminal Code.
