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 (the Act).

Recent negotiations between the Department and the Pharmacy Guild of Australia have resulted in amendments to the Rules, which will apply to applications made on or 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.

All applications are to be lodged through the Department of Human Services and require the use of the application form available on the Department of Human Services website. Applicants wishing to lodge an application for consideration under the Rules should consult the Pharmacy Location Rules – Applicant’s Handbook.

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.

Note: The Secretary’s responsibilities concerning the approval of pharmacists have been conferred on the Chief Executive Medicare, who has delegated these powers to certain officers in the Department of Human Services.

In making its recommendation to the Secretary’s delegate in the Department of Human Services, the ACPA must comply with the requirements specified in the Rules as determined by the Minister.

The Department of Health 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.

Contact details are as follows:

Australian Community Pharmacy Authority Secretariat
Department of Health
GPO Box 9848 (MDP 659)
CANBERRA ACT 2601

Telephone: 02 6289 2419
Facsimile: 02 6289 2365
Email 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 application form must be lodged with the Department of Human Services, together with all of the supporting documents before the deadline for the corresponding ACPA meeting. The Department of Human Services will register applications before forwarding them to the ACPA secretariat in the Department of Health.

Complete applications should be lodged by email to the NSW PBS Approvals Clerk. Individual emails, including attachments cannot exceed 100 Mb. For more information contact a Pharmacy Programe Officer on 132 290.

Please note: It is advisable for an applicant to retain the original documentation and provide copies with the application as no paperwork will be returned.

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 of Human Services are outlined in the table below.
Please note these dates are subject to change.
(Table current as at 18 September 2018)

ACPA Meeting date	Timeframe to lodge an Application with the Department of Human Services	Timeframe to lodge an Application with the Department of Human Services
Friday	From	To
28 September 2018	Tuesday 24 July 2018	Monday 27 August 2018
2 November 2018	Tuesday 28 August 2018	Tuesday 2 October 2018
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 of Human Services 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.

ACPA Recommendations

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 in the Department of Human Services will be advised of the decision in writing 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 of Human Services is responsible for granting the approval to supply pharmaceutical benefits. Applicants should contact a Pharmacy Programe Officer in the Department of Human Services by phoning 132 290 to discuss the next steps in the process.

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?

The ACPA Secretariat can be contacted by phoning (02) 6289 2419 and leaving your name, phone number and a brief message about your inquiry. If you are phoning about your application, please quote your application reference number when leaving your message.

A member of the Secretariat will return your call as soon as possible. Please note that it is not always possible for the Secretariat to return calls on the same business day, but please be assured that your call will returned as soon as possible.

Alternatively, send an email to the ACPA. Your enquiry will be answered as soon as practicable.

Pharmacy affected by disaster

If a pharmacy is unable to operate due to disaster, an application can be made to supply PBS medicines at alternative premises for a temporary period using the existing pharmacy approval number. An email can be sent to the ACPA, including details of the disaster and the alternative premises. An application should be made within 14 days of operating the pharmacy at alternative premises. For further information please phone (02) 6289 2425 Monday to Friday (excluding public holidays).

Ministerial Discretion

The Minister for Health has a discretionary power to approve pharmacies in unusual circumstances where the application of the location rules results in a community being left without reasonable access to the supply of pharmaceutical benefits by an approved pharmacist, and approval of the pharmacy is in the public interest. Further information on the Minister’s discretionary power is available at the Ministerial Discretion on Pharmacy Location home page.