Pharmacy Location Rules
The Rules relate to the establishment of a new pharmacy or the relocation of an existing pharmacy which has approval to provide PBS medicines under section 90 of the National Health Act 1953
Recent negotiations between the Department and the Pharmacy Guild of Australia resulted in amendments to the Rules, which apply to applications made after 3 October 2018. Frequently Asked Questions
are available to summarise some of the amendments.
The amended Rules are legislated under the National Health (Australian Community Pharmacy Authority Rules) Determination 2018
made under section 99L of the Act.
The Rules set out location-based criteria which must be met in order for the ACPA to recommend approval of a pharmacist. The ACPA cannot override the requirements of the Rules. It can only recommend that an application be approved if it is satisfied that all of the requirements of the Rule, under which the application was made, have been met. Similarly, the ACPA is unable to recommend that an application be approved if it is not satisfied that each of the requirements has been met.
The Rules remain consistent with the overall objective of the National Medicines Policy to improve the health outcomes of all Australians through access to and quality use of medicines.
As a result of the transfer of administrative functions for pharmacy approval applications, from the Department of Human Services, to the Department of Health (Health), applicants wishing to lodge an application for consideration under the Rules, are now required to lodge the application with Health, via the Health Data Portal
using an AUSkey. Applicants should consult the Pharmacy Location Rules – Applicant’s Handbook
before lodging an application.
Australian Community Pharmacy Authority (ACPA)
The ACPA is an independent statutory authority established under section 99J of the Act.
The ACPA has six part-time members, five of whom are appointed by the Minister and one appointed by the Secretary of the Department of Health (the Secretary).
The ACPA considers applications for approval to supply pharmaceutical benefits under section 90 of the Act and makes recommendations to delegated officers as to whether or not an application should be approved.
In making its recommendation to the Secretary’s delegate the ACPA must comply with the requirements specified in the Rules as determined by the Minister.
The Department provides secretariat services to the ACPA. The ACPA Secretariat also assists applicants with enquiries about the Rules, and serves as the liaison between pharmacists and the ACPA.
Applications for approval to supply pharmaceutical benefits under section 90 of the National Health Act 1953
The Pharmacy Location Rules – Applicant’s Handbook provides pharmacists with comprehensive information about:
- the Rules and the ACPA;
- the application process including the requirements that must be satisfied and the types of information that must be included in an application; and
- seeking further information or assistance.
It is up to the applicant to select the rule which best suits their situation as each rule has different requirements. Applicants must satisfy all of the requirements for a particular rule if they are to receive a recommendation for approval from the ACPA.
A completed pharmacy approval application form
or change of detail form
must be lodged via the Health Data Porta
l using an AUSkey. For more information, contact the Department on 02 6289 2419.
Please note: It is advisable for an applicant to retain the original documentation and provide copies with the application.
ACPA Meeting dates
The ACPA meeting dates for the remainder of 2018 and 2019, and the corresponding application lodgement timeframes for complete applications to be received by the Department are outlined in the table below.
Please note these dates are subject to change.
(Table current as at 6 December 2018)
|ACPA Meeting date||Timeframe to lodge an Application ||Timeframe to lodge an Application |
|7 December 2018||Wednesday 3 October 2018||Monday 5 November 2018|
|18 January 2019||Tuesday 6 November 2018||Monday 10 December 2018|
|1 March 2019||Tuesday 11 December 2018||Tuesday 29 January 2019|
|12 April 2019||Wednesday 30 January 2019||Monday 4 March 2019|
|17 May 2019||Tuesday 5 March 2019||Monday 15 April 2019|
|21 June 2019||Tuesday 16 April 2019||Monday 20 May 2019|
|26 July 2019||Tuesday 21 May 2019||Monday 24 June 2019|
|30 August 2019||Tuesday 25 June 2019||Monday 29 July 2019|
|4 October 2019||Tuesday 30 July 2019||Monday 2 September 2019|
|8 November 2019||Tuesday 3 September 2019||Tuesday 8 October 2019|
|13 December 2019||Wednesday 9 October 2019||Monday 11 November 2019|
|31 January 2020||Tuesday 12 November 2019||Monday 16 December 2019|
Note: Application lodgement timeframes are to ensure that the Department and the ACPA Secretariat have sufficient time to process and register applications, undertake consultation with third parties where relevant and for the ACPA to give proper consideration of applications.
The ACPA Secretariat will endeavour to advise applicants of the outcome of their application, by email on the next working day after the meeting.
More detailed correspondence will follow as outlined below:
ACPA recommends that an application be approved
If the ACPA has made a decision to recommend that an application be approved, in most cases the Secretary’s delegate will be advised of the decision the next working day
after the meeting.
Note:If the recommendation by the ACPA is to approve the application, the relevant delegate in the Department is responsible for granting the approval to supply pharmaceutical benefits.
ACPA recommends that an application not be approved
If the ACPA has made a decision to recommend that an application not be approved, it will endeavour to inform the applicant of the decision, including the reason(s) for the decision and the rights of review within ten working days
after the meeting.
ACPA defers making a recommendation on an application
If the ACPA defers consideration of the application to the next meeting, the Secretariat will endeavour to advise the applicant of the reasons for the deferral within five working days
after the meeting.
Surrounding pharmacists who provided comments on an application
The ACPA will endeavour to advise the outcome of an application to any pharmacist/s who provided comments to the ACPA, as soon as practicable, but generally no sooner than ten working days
after a meeting. Please note that the Authority does not advise surrounding pharmacists of the meeting outcome if the Authority has deferred making a recommendation.
How do I contact the ACPA?
For any queries please email firstname.lastname@example.org
or phone the PBS Approved Suppliers
hotline on (02) 6289 2419.