Pharmacy Business Ownership Act 2024Pharmacy Business Ownership Regulation 20251Short titleThis regulation may be cited as the Pharmacy Business Ownership Regulation 2025.2CommencementThis regulation commences on 1 November 2025.3Prescribed standards for authorised premisesFor section 11(1)(b) of the Act, the standards for premises stated in schedule 1 are prescribed.4FeesThe fees payable under the Act are stated in schedule 2.Schedule 1Standards for premisessection 3Part 1Preliminary1Definition for scheduleIn this schedule—dispensary means an area dedicated to storing and dispensing medicines.Part 2Standards

1The premises must be a building or other structure, or a part of a building or other structure, and must not, for example, be a caravan or vehicle.

2The premises must be appropriately lit, temperature-controlled and ventilated to ensure the following are not compromised—

(a)the integrity of medicines kept at the premises;

(b)the standard of pharmacy services provided at the premises;

(c)the safety and comfort of persons at the premises.

3The premises must be kept appropriately organised and uncluttered to ensure the following are not compromised—

(a)the standard of pharmacy services provided at the premises;

(b)the safety and comfort of persons at the premises.

4The premises must—

(a)be clean and hygienic; and

(b)have appropriate measures in place to ensure—

(i)the premises are kept clean and hygienic; and

(ii)the risk of contamination of medicines at the premises is minimised; and

(iii)the risk of infection at the premises is minimised.

Examples of measures for paragraph (b)—hand washing facilities, sharps disposal, clinical waste disposal, cleaning arrangements

5The premises must have a sink that—

(a)is supplied with hot and cold running water; and

(b)has an integrated drainer.

6The premises must have a dispensary that—

(a)is of an appropriate size and design to ensure the standard of dispensing medicines and tasks associated with dispensing medicines are not compromised; and

(b)has a refrigerator dedicated to storing medicines with an internal temperature capable of being monitored and controlled at all times; and

(c)has all other equipment necessary for dispensing medicines or performing tasks associated with dispensing medicines, including, for example, a barcode scanner; and

(d)is constructed in a way that minimises the risk of unauthorised access to the dispensary.

7The premises must have an area, for conducting private consultations with customers of the pharmacy business carried on at the premises, that—

(a)is separate from the dispensary at the premises; and

(b)is of an appropriate size and design to ensure—

(i)the comfort of persons involved in the consultation, including, for example, by including appropriate seating; and

(ii)the risk of the consultation being seen or heard by someone who is not involved in the consultation is minimised; and

(iii)the area contains all equipment necessary for conducting the consultation; and

(iv)the standard of the consultation is not compromised.

8The premises must be constructed in a way that minimises the risk of unauthorised access to the premises.

9Each means of access to the premises must be able to be secured in a way that minimises the risk of unauthorised access to the premises.Examples of a means of access—door, window, skylight

10The premises must have equipment that detects unauthorised access to the premises at all times an authorised pharmacist for the pharmacy business carried on at the premises, or a person under the direction or control of the authorised pharmacist, is not at the premises.Examples—alarm system, security cameras

11If the premises are licensed premises, the premises must have the following information on display to customers of the pharmacy business carried on at the premises—

(a)the name of each holder of the pharmacy business licence for the business;

(b)if the authorised pharmacist for the business is not a person mentioned in paragraph (a)—the name of the authorised pharmacist.

Schedule 2Feessection 4Part 1Preliminary1Definitions for scheduleIn this schedule—tier 1 application means—

(a)an application by 1 person, if the person’s ownership of the pharmacy business to which the application relates—

(i)does not involve ownership as trustee of a trust; or

(ii)involves ownership as trustee of only 1 trust; or

(b)an application made jointly by 2 persons, if—

(i)not more than 1 of the persons is a corporation; and

(ii)the persons’ joint ownership of the pharmacy business to which the application relates—

(A)does not involve ownership as trustee of a trust; or

(B)involves ownership as trustee of only 1 trust.

tier 2 application means—

(a)an application by 1 person, if the person’s ownership of the pharmacy business to which the application relates involves ownership as trustee of only 2 trusts; or

(b)an application made jointly by 2 persons, if—

(i)it is not a tier 1 application; and

(ii)the persons’ joint ownership of the pharmacy business to which the application relates—

(A)does not involve ownership as trustee of a trust; or

(B)involves ownership as trustee of only 1 or 2 trusts; or

(c)an application made jointly by 3, 4 or 5 persons, if—

(i)not more than 2 of the persons are corporations; and

(ii)the persons’ joint ownership of the pharmacy business to which the application relates—

(A)does not involve ownership as trustee of a trust; or

(B)involves ownership as trustee of only 1 or 2 trusts.

tier 3 application means an application other than a tier 1 application or tier 2 application.Part 2FeesFee units1Application fee for pharmacy business licence (Act, s 25(1)(c))—(a)if the application is a tier 1 application2,075.45(b)if the application is a tier 2 application2,358.50(c)if the application is a tier 3 application3,018.852Fee for inspecting premises (Act, ss 27(1)(b) and 50(1)(b)(ii))849.053Licence fee for pharmacy business licence (Act, s 29(3)(b))377.354Application fee to renew pharmacy business licence (Act, s 33(4)(b))—(a)if the application is a tier 1 application1,603.75(b)if the application is a tier 2 application1,792.45(c)if the application is a tier 3 application2,358.505Application fee to restore pharmacy business licence (Act, s 34(3)(b))—(a)if the application is a tier 1 application1,698.10(b)if the application is a tier 2 application1,886.80(c)if the application is a tier 3 application2,452.856Application fee to add incoming party as holder of pharmacy business licence (Act, s 38(2)(b))849.057Application fee to remove person as holder of pharmacy business licence (Act, s 43(3)(b))471.708Application fee to change licensed premises for pharmacy business (Act, s 49(2)(c))613.209Application fee to add to, or remove from, pharmacy business licence the name of a person (Act, s 53(2)(b))471.7010Application fee to change detail stated on pharmacy business licence (Act, s 59(2)(b))377.3511Fee for having reviewer carry out, and prepare report on, review of document (Act, s 74(2)(b))2,358.50