The latest news and updates with regard to the Rules and the ACPA is available on the Pharmacy Location Rules News page.
Pharmacy Location Rules
The Rules are a fundamental component of the Sixth Community Pharmacy Agreement (the Sixth Agreement) between the Commonwealth of Australia (as represented by the Australian Government Department of Health) and the Pharmacy Guild of Australia (the Guild). This Agreement commenced on 1 July 2015 and terminates on 30 June 2020.
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).
The Rules, which took effect on 18 October 2011, were agreed by the Department and the Guild, with minor amendments incorporated for applications made on or after 10 November 2015. The Rules are legislated under the
National Health (Australian Community Pharmacy Authority Rules) Determination 2011 made under section 99L of the Act.
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.
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.
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 859)
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 Top of page
The Pharmacy Location Rules – Applicant’s Handbook (revised in November 2015) 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 Programme 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 2017, 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 8 August 2017)
| 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 |
|---|
| 18 August 2017 | Wednesday 14 June 2017 | Monday 17 July 2017 |
| 22 September 2017 | Tuesday 18 July 2017 | Monday 21 August 2017 |
| 27 October 2017 | Tuesday 22 August 2017 | Tuesday 26 September 2017 |
| 8 December 2017 | Wednesday 27 September 2017 | Monday 6 November 2017 |
| 19 January 2018 | Tuesday 7 November 2017 | Monday 11 December 2017 |
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 and surrounding pharmacists of decisions within the following timeframes:
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 Programme Officer in the Department of Human Services by phoning 132 290 to discuss the next steps in the process.
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.
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.
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.
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 APCA, or write to the ACPA at the Department of Health, MDP 859, GPO Box 9848, Canberra ACT 2601. 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.
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