Pursuant to section 105 of the Medicines Act 1981, Her Excellency the Governor-General, acting on the advice of the Minister of Health tendered after consultation with the organisations or bodies appearing to the Minister to be representative of persons likely to be substantially affected, and acting on the advice and with the consent of the Executive Council, makes the following regulations.

1 Title

(1) These regulations are the Medicines Amendment Regulations 2005.

(2) In these regulations, the Medicines Regulations 1984¹ are called “the principal regulations”.

2 Commencement

These regulations come into force on 1 October 2005.

3 Interpretation

Regulation 2(1) of the principal regulations is amended by revoking the definition of designated prescriber nurse.

4 Consumer information panel

Regulation 20(1) of the principal regulations is amended by omitting the words “a practitioner, registered midwife, or designated prescriber nurse”, and substituting the words “an authorised prescriber”.

5 Labels on containers of medicines sold by practitioners, registered midwives, designated prescriber nurses, or pharmacists

(1) The heading to regulation 23 of the principal regulations is amended by omitting the words “practitioners, registered midwives, designated prescriber nurses,”, and substituting the words “authorised prescribers”.

(2) Regulation 23 of the principal regulations is amended by omitting the words “a practitioner, a registered midwife, a designated prescriber nurse,”, and substituting the words “an authorised prescriber”.

6 Containers for medicines, related products, and cosmetics

Regulation 35(8)(b) of the principal regulations is amended by omitting the words “practitioners, veterinary surgeons, registered midwives, or designated prescriber nurses”, and substituting the words “authorised prescribers, or veterinary surgeons”.

7 Safety containers

Regulation 37(2)(a) of the principal regulations is amended by omitting the words “a practitioner, registered midwife, or designated prescriber nurse”, and substituting the words “an authorised prescriber”.

8 Conditions under which practitioners, veterinary surgeons, registered midwives, and designated prescriber nurses may prescribe prescription medicines

(1) The heading to regulation 39 of the principal regulations is amended by omitting the words “practitioners, veterinary surgeons, registered midwives, and designated prescriber nurses”, and substituting the words “authorised prescribers and veterinary surgeons”.

(2) Regulation 39(7) of the principal regulations is amended by omitting the words “designated prescriber nurse”, and substituting the words “nurse authorised to prescribe a prescription medicine by regulations made under the Act”.
(3) Regulation 39 of the principal regulations is amended by adding the following subclause:
- “(8) No optometrist authorised to prescribe a prescription medicine by regulations made under the Act may—
  
  “(a) prescribe any prescription medicine if the optometrist is prohibited by a notice under section 48(1) of the Act from prescribing that prescription medicine or any prescription medicines of a class or description that includes that prescription medicine; or
  
  “(b) prescribe any prescription medicine otherwise than for the treatment of a patient who is under the optometrist's care; or
  
  “(c) prescribe for a patient a quantity of a prescription medicine that exceeds 3 months' supply:”

9 Prescriptions to comply with regulations

Regulation 40(1) of the principal regulations is amended by omitting the words “practitioner, veterinary surgeon, registered midwife, or designated prescriber nurse”, and substituting the words “authorised prescriber or veterinary surgeon”.

10 Urgently required prescriptions of prescription medicines may be communicated orally if later confirmed in writing

(1) Regulation 40A(1) of the principal regulations is amended by omitting the words “a practitioner, veterinary surgeon, registered midwife, or designated prescriber nurse”, and substituting the words “an authorised prescriber or veterinary surgeon”.

(2) Regulation 40A(1) of the principal regulations is amended by omitting the words “the practitioner, veterinary surgeon, registered midwife, or designated prescriber nurse”, and substituting the words “the authorised prescriber or veterinary surgeon”.

(3) Regulation 40A(2) of the principal regulations is amended by omitting the words “a practitioner, veterinary surgeon, registered midwife, or designated prescriber nurse”, and substituting the words “an authorised prescriber or veterinary surgeon”.

(4) Regulation 40A(2) of the principal regulations is amended by omitting the words “the practitioner, veterinary surgeon, registered midwife, or designated prescriber nurse”, and substituting the words “the authorised prescriber or veterinary surgeon”.

11 Dispensing of prescription medicines

(1) Regulation 42(1) is amended by omitting the words “a practitioner, veterinary surgeon, registered midwife, designated prescriber nurse”, and substituting the words “an authorised prescriber, veterinary surgeon”.

(2) Regulation 42(4) of the principal regulations is amended by omitting the words “practitioner, veterinary surgeon, registered midwife, or designated prescriber nurse” in both places where they appear, and substituting in each case the words “authorised prescriber or veterinary surgeon”.

12 Prescriptions for prescription medicines not required in certain cases

(1) Regulation 44 of the principal regulations is amended by revoking paragraphs (f) to (hb), and substituting the following paragraphs:
- “(f) an authorised prescriber or veterinary surgeon; or
- “(g) a patient under his or her care by an authorised prescriber; or
- “(h) a patient under the care of an authorised prescriber for administration to the patient in accordance with the instructions of the authorised prescriber; or”.
(2) Regulation 44(m) of the principal regulations is amended by omitting the words “a medical practitioner, registered midwife, or designated prescriber nurse”, and substituting the words “an authorised prescriber (except a dentist)”.

13 Duty to supply information

(1) Regulation 44B(1) of the principal regulations is amended by omitting the words “practitioner, registered midwife, or designated prescriber nurse” in both places where they appear, and substituting in each case the words “authorised prescriber”.

(2) Regulation 44B(4) of the principal regulations is amended by omitting the words “A practitioner, registered midwife, or designated prescriber nurse”, and substituting the words “An authorised prescriber”.

14 Offences

Regulation 64(1)(a) of the principal regulations is amended by inserting, before the expression “40(1)”, the expression “39(8),”.

15 Schedule 1 amended

Parts 1A and 1B of Schedule 1 of the principal regulations are amended by omitting the words “to be a designated prescriber nurse”, and substituting in each case the words “for a nurse to be authorised by regulations under the Act to prescribe prescription medicines”.

Diane Morcom,

Clerk of the Executive Council.

Explanatory note

This note is not part of the regulations, but is intended to indicate their general effect.

These regulations come into force on 1 October 2005.

They amend the Medicines Regulations 1984 consequentially on the making of the Medicines (Designated Prescriber: Optometrists) Regulations 2005, which provide for the authorisation of optometrists to prescribe certain prescription medicines. This authorisation of optometrists makes them designated prescribers under the Medicines Act 1981. As a result, optometrists are also authorised prescribers under that Act, along with medical practitioners, dentists, registered midwives, and nurses who are authorised by regulations under that Act to prescribe certain prescription medicines.

The amendments ensure that the Medicines Regulations 1984 deal with optometrists authorised to prescribe prescription medicines in a way that is generally similar to the way that those regulations deal with other people who are authorised prescribers.

Issued under the authority of the Acts and Regulations Publication Act 1989.

Date of notification in Gazette: 1 September 2005.

1 SR 1984/143

Medicines Amendment Regulations 2005