Pharmacy Location Rules News

This site provides information about the Pharmacy Location Rules and the Australian Community Pharmacy Authority (ACPA).

Page last updated: 18 November 2016

Amendment to Pharmacy Location Rules News of September 2016

Please be advised that it has been brought to our attention that there was some incomplete information contained in the recently published Pharmacy Location Rules News, September 2016. This was in reference to the description of a Medical practitioner on page 2 of the PDF version of the communique. The description of a Medical practitioner in the below html version of the communique has been updated to reflect this amendment. The Printable PDF version of the communique now also contains an amendment notice.

Updated Description:
      The term medical practitioner, as it appears in the Rules, means a person registered or licensed as a medical practitioner under a State or Territory law, and does not include a person whose registration or license has been suspended or cancelled. It is distinct from the term prescribing medical practitioner, which is defined in the Rules to mean a medical practitioner who provides general practice services to the community in which he or she practises, including the issuing of prescriptions for pharmaceutical benefits. Not all medical practitioners will be prescribing medical practitioners for the purposes of the Rules.
      In calculating the number of prescribing medical practitioners practising at a medical centre, the hours worked by other prescribers or providers of services that are not included in the definition, such as specialists who are not providing general practice services to the community in which they practise, are not able to be included.
The Authority apologises for any confusion caused.

Superseded description of a Medical practitioner published in the Pharmacy Location Rules News, September 2016: 'Medical practitioner means a person registered or licensed as a medical practitioner under a State or Territory law, and does not include a person whose registration or license has been suspended or cancelled. For the purposes of the Rules, the requirements associated with a medical practitioner require that the medical practitioner provides general practice services in the relevant community and issues prescriptions for pharmaceutical benefits.
In calculating the number of PBS prescribers practising at a medical centre, the hours worked by other prescribers or providers of services that are not included in the definition of “PBS prescriber”, such as specialists, are not able to be included.'

Pharmacy Location Rules News - September 2016

Printable version of news - September 2016 - updated with amendment notice November 2016 (PDF 781 KB)

The following information is provided to assist applicants to prepare an application for the establishment of a new, or the relocation of an existing pharmacy approved to supply pharmaceutical benefits scheme (PBS) medicines under section 90 of the National Health Act 1953 (the Act). In addition, it is strongly recommended that all potential applicants consult the Pharmacy Location Rules Applicant’s Handbook before lodging an application.

New pharmacy in a facility (large medical centre) applications

There continues to be some confusion regarding the evidence that is required to support an application to establish a new pharmacy in a facility (large medical centre), Rule 136. The following explains:


Evidence that premises are approved for the purpose of operating a pharmacy and are accessible by the public (Item 211(c)(i) and (ii))

One of the general requirements for all applications is that the proposed premises could be used for the operation of a pharmacy under applicable local government and State or Territory laws relating to land development, and that the premises would be accessible by the public. For large medical centre applications often there is insufficient evidence provided to demonstrate this requirement.


Large medical centre applications should provide evidence:
a) that the land is suitably zoned to allow the operation of a pharmacy (such as a letter from the local council confirming that the proposed premises are able to be used for the purpose of operating a pharmacy without the need for a development application); or
b) showing that planning approval for a pharmacy to operate at the proposed premises has been obtained (such as a decision notice approving a development application to vary or change the use of the proposed premises for the purpose of operating a pharmacy).

When approving the development of a medical centre, it is not uncommon for the local government to approve an ‘ancillary’ pharmacy or dispensary. Often the local government intends that the ‘ancillary’ nature of the pharmacy or dispensary approval restricts the use of the pharmacy to patients of the medical centre. For this reason, it is also important for large medical centre applications to show that the local government has not placed any restrictions on who may access the pharmacy. Therefore, where evidence has been provided that identifies the pharmacy as an ‘ancillary’ pharmacy, details must also be provided to confirm the local government’s definition of ‘ancillary’, and any access conditions that may restrict members of the public accessing the proposed premises.

The approval by the landlord within the lease to operate a pharmacy is not sufficient evidence to support this requirement. Neither is referring the ACPA to a website for information on local government zoning.

Evidence that the proposed premises are in a large medical centre (Item 136(1))

The ACPA must be satisfied that the proposed premises are in a large medical centre. Section 5 of the National Health (Australian Community Pharmacy Authority Rules ) Determination 2011 (PB 65 of 2011) defines a large medical centre as one that: is under single management; operates for at least 70 hours each week; and has one or more prescribing medical practitioners at the centre for at least 70 hours each week.


A statutory declaration (made on a Commonwealth of Australia statutory declaration template) from the manager or owner of the medical centre to confirm the medical centre is under single management; operates for at least 70 hours each week; and has one or more prescribing medical practitioners at the centre for at least 70 hours each week should be provided. In relation to single management, this statutory declaration should not just state that the medical centre is under single management, it should also explain why the medical centre is under single management, in line with the definition of single management defined in PB 65 of 2011.

Evidence that supports the number of PBS prescribers at the medical centre

Many applicants are failing to address the requirements of Item 136(4). Item 136(4) requires that the ACPA must be satisfied that, for the two months prior to the day the application is made, and for the two months prior to the day ACPA considers the application, there must be at least eight full-time PBS prescribers, of which at least seven must be prescribing medical practitioners (i.e. general practitioners) practising at the medical centre.


The Explanatory Statement to PB 65 of 2011 defines “full-time” and “the equivalent of”, “PBS prescriber” and “medical practitioner” as follows:

Full-time PBS prescriber (including medical practitioner) means providing the services of a PBS prescriber for at least 38 hours each week. For example, for a medical practitioner, time spent consulting with patients at their home or in hospital is included when calculating the hours that a medical practitioner practises at a medical centre. Time spent consulting at other medical centres, working at a hospital (rostered duties), attending nursing homes and undertaking administration work for the medical centre/practice, such as staff rosters, is not counted towards the time spent practising at the medical centre/practice.

The equivalent of a full-time PBS prescriber means any number of PBS prescribers who provide the equivalent services of one full-time PBS prescriber. For example, if one part-time PBS prescriber practises 20 hours each week and another practises 18 hours each week, then they will be considered the equivalent to one full-time PBS prescriber as their combined practice hours equal 38 hours. Similarly, if one PBS prescriber practises 57 hours each week then they are considered the equivalent to one and a half full-time PBS prescribers.

The Rules do not require that there be eight full-time PBS prescribers practising at the one time for Item 136(4) to be met.

PBS prescriber means a medical practitioner or a participating dental practitioner, or an authorised optometrist, midwife or nurse practitioner.

The term medical practitioner, as it appears in the Rules, means a person registered or licensed as a medical practitioner under a State or Territory law, and does not include a person whose registration or license has been suspended or cancelled. It is distinct from the term prescribing medical practitioner, which is defined in the Rules to mean a medical practitioner who provides general practice services to the community in which he or she practises, including the issuing of prescriptions for pharmaceutical benefits. Not all medical practitioners will be prescribing medical practitioners for the purposes of the Rules.

In calculating the number of prescribing medical practitioners practising at a medical centre, the hours worked by other prescribers or providers of services that are not included in the definition, such as specialists who are not providing general practice services to the community in which they practise, are not able to be included.

To address this requirement, the following evidence is required at the time the section 90 application is made:
a) a statutory declaration (made on a Commonwealth of Australia statutory declaration template) from the owner or practice manager of the medical centre confirming the hours the medical centre operates and the hours that each PBS prescriber practices;
b) copies of any advertisements regarding the hours the medical centre operates;
c) a practice information sheet; and
d) rosters from the medical centre for the two months prior to the day the application is made.

In addition, the ACPA also requests that evidence be provided to demonstrate the Australian Health Practitioner Regulation Agency registration status of the PBS prescribers at the medical centre. That is whether the PBS prescribers are general practitioners or specialists, and any restrictions such as supervision requirements.

If supervision requirements exist, details also should be provided on what type of supervision is required and by whom this supervision is being undertaken. Depending on the level of supervision required, and if the supervision is undertaken by another PBS prescriber at the medical centre, the hours spent supervising may not be able to be attributed to the supervising medical practitioners hours.

In addition to the evidence that is required when submitting an application for a new pharmacy in a medical centre, prior to the ACPA meeting in which the application will be considered, the ACPA Secretariat will contact the medical centre requesting rosters that cover the period from the day the application was made until the day the application is to be considered by the ACPA. At this time, the medical centre should only provide the requested rosters and not any additional information to support the application. If any additional information is provided by the medical centre it will not be reviewed by the ACPA when it considers the application.

When providing medical centre rosters, the actual times (start and finish times) and total number of hours worked by each PBS prescriber for each and every week must be provided. Rosters must also factor in any breaks the PBS prescriber has and must not include time spent consulting at other medical centres, working at a hospital (rostered duties), attending nursing homes and undertaking administration work for the medical centre/practice, such as staff rosters, as they do not count towards the time spent practising at the medical centre/practice.

Short distance relocation (1 km) applications

One of the requirements of the short distance relocation Rule 124 is that the ACPA be satisfied that either the existing (current) premises are not in a facility (Item 124(2)(a)) or that if the existing (current) premises are in a facility, that the proposed (new) premises are at least 500 m, by straight line, from all approved premises not located in that same facility (Item 124(2)(b)).


Many applicants are failing to address this requirement, or are instead providing evidence of whether the proposed (new) premises are located in a facility or not.

A facility is defined as a small shopping centre, a large shopping centre, a large medical centre or a large private hospital, definitions of which are also included in PB 65 of 2011.

Please refer to the Handbook for further information on these requirements.

Presentation of scaled map in support of distance requirements

The ACPA has observed that many of the scaled maps that are being provided as evidence in support of distance requirements do not have scales that are in proportion to the size of the map and therefore the distance shown on the map. This is predominantly evident in maps that have been generated from web based mapping tools such as Google Maps and Google Earth.


Please be aware that the ACPA will generally not rely on evidence of measurements provided by web based mapping tools only. It is preferable that a clearly scaled map, highlighting the location and addresses of the relevant premises is provided. The scaled map should clearly identify and label the relevant premises, and include a statement of the distance between all of the relevant premises. The scale should also be clearly shown on the map and correctly reflect the scale of the map. It is preferable that symbols be used to identify locations rather than colour.

If the distance between the relevant premises is near to the required distance, applicants should provide a report from a licensed or registered surveyor. Any surveyor’s report should include:
  • a clearly scaled map;
  • a description of the methodology and equipment used in the measurement;
  • the straight line distance measured;
  • the margin for error in the measurement;
  • detailed information about the public access doors to each of the premises; and
  • confirmation that the measurement has been undertaken from the mid-point at ground level of the public access door or each of the premises.

Provision of additional information

Many applicants are submitting additional information in support of their application after the application has been lodged and referred to the ACPA.


PB 65 of 2011 allows that the ACPA may only consider information provided by an applicant if:
a) the information was given at the time the application was made; or
b) the ACPA requested the information.
Where an applicant provides additional information and the information was not requested by the ACPA, it will not be considered by the ACPA when assessing the application.

Meeting dates for 2017


The ACPA meeting dates for 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 and any updates will be published on the Department of Health website.

ACPA Meeting date
    Timeframe to lodge an Application with the Department of Human Services
FridayFrom
    To
20 January 2017Tuesday 8 November 2016
    Monday 12 December 2016
24 February 2017Tuesday 13 December 2016
    Monday 23 January 2017
31 March 2017Tuesday 24 January 2017
    Monday 27 February 2017
5 May 2017Tuesday 28 February 2017
    Monday 3 April 2017
9 June 2017Tuesday 4 April 2017
    Monday 8 May 2017
14 July 2017Tuesday 9 May 2017
    Tuesday 13 June 2017
18 August 2017Wednesday 14 June 2017
    Monday 17 July 2017
22 September 2017Tuesday 18 July 2017
    Monday 21 August 2017
27 October 2017Tuesday 22 August 2017
    Tuesday 26 September 2017
8 December 2017Wednesday 27 September 2017
    Monday 6 November 2017
19 January 2018Tuesday 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 and for the ACPA to give proper consideration of applications.

Update – 23 October 2015


The Minister for Health, the Hon Sussan Ley MP, has made minor amendments to the Pharmacy Location Rules (the Rules), which take effect on 10 November 2015.

The amendments, contained in the National Health (Australian Community Pharmacy Authority Rules) Amendment Determination 2015 (No. 1), were uploaded onto the Federal Register of Legislative Instruments on 22 October 2015 and are available from the Comlaw website.

The amendments involve the removal of three obsolete provisions, changes to some definitions and clarification of some provisions, for example the removal of the provision which meant that a pharmacy, recommended to relocate in a town, was considered to be two pharmacies.

Any application made on or after 10 November 2015, to establish a new pharmacy or relocate an existing pharmacy, will be considered under the amended Rules.

The amendments are being incorporated into the principal instrument, which will be available from the Comlaw website shortly.

To assist applicants in understanding the amendments, the Pharmacy Location Rules – Applicant’s Handbook is being updated and will be available shortly on the 'Pharmacy Location Rules (the Rules) and the Australian Community Pharmacy Authority (ACPA)' page on the Department of Health’s website.

Pharmacy Location Rules News - September 2014

Printable version of news - September 2014 (PDF 483 KB)

Lodging an application to establish a new pharmacy or relocate an existing pharmacy

As advised in previous editions of Pharmacy Location Rules News, complete applications for approval to supply pharmaceutical benefits under section 90 of the National Health Act 1953 should be lodged by email to
PBS Approvals.

Applicants are encouraged to lodge applications by email to this address. Applicants should be aware that if they lodge an application by another method such as post or facsimile, or by sending the application to another email address within the Department of Human Services, there is a risk that another application will be registered ahead of theirs if an application for the same area has been received at the central email address around the same time.
Applications cannot be lodged directly with the ACPA, nor is it necessary to copy the ACPA when emailing an application. The ACPA cannot commence processing an application until it has been referred by the Department of Human Services.

When emailing an application, the application and any attachments cannot exceed 100 Mb in size. To assist with managing the size of applications, it is recommended that applications be provided in black and white, with any colour documents such as maps and photos provided in a separate file. For example, when scanning documents, where possible, use colour scanning only for those pages that require colour, and then scan the remaining pages separately using black and white (or mono).

The ACPA has asked that applicants clearly label documents provided in support of an application, for example, by including the attachment or appendix reference in text on the document itself rather than only in the electronic file title.
For assistance or for more information about lodging an application, contact a Pharmacy Programme Officer in the Department of Human Services on 132 290.

Important information for applicants

Evidence of premises being approved to operate as a pharmacy under applicable state or territory laws

A general requirement for all applications is that the proposed premises, on the day the application was made and on the day the ACPA makes its recommendation in respect of the application, could be used for the operation of a pharmacy under applicable local government and state or territory laws relating to land development. The ACPA must be satisfied that the operation of a pharmacy on the land on which the proposed premises are located is a permissible use under relevant Council zoning. If the ACPA has any concerns or doubts, it may request additional information.


Volume and quality of evidence

Applicants are discouraged from providing large volumes of evidence without summarising how the evidence is relevant to the criteria. It is not the ACPA’s responsibility to examine and extract information from large volumes of information to identify how it satisfies the requirements of the Rules. A particular example of where this frequently occurs is in the provision of evidence to demonstrate that the proposed premises could be used for the operation of a pharmacy. Applicants regularly provide large extracts of, or at times, the full Council planning documents without any references to the relevant sections. In such cases, it is difficult and time consuming for the ACPA to determine how the documents are relevant, and may result in the ACPA being unable to be satisfied that the particular requirement is met.


Where photographs are provided as evidence, they should be clearly labelled and dated to allow the ACPA to determine how they relate to the application and their currency.

Evidence of legal right to proposed premises

Evidence, such as agreements to lease, provided to support an applicant’s legal right to occupy their proposed premises, often include a statement to the effect that the agreement is non-binding until, for example, certain conditions have been met, or a formal lease has been entered into. In such circumstances, the ACPA may be unable to accept this evidence alone as being sufficient to demonstrate legal right due to the non-binding nature of the agreement, and this may result in the ACPA recommending that the application not be approved.


Evidence of the distance to the nearest approved pharmacy

The ACPA continues to receive poor quality or illegible maps that do not sufficiently identify relevant premises or include statements of distance. In addition, the ACPA continues to receive evidence of distance using only web based mapping tools.

There is also often insufficient evidence provided to demonstrate that an approved pharmacy is in a facility where relevant. For example, Rule 136 (new pharmacy in a large medical centre) requires that the proposed premises are at least 500 metres, in a straight line, from the nearest approved premises other than an approved premises in a small or large shopping centre, or private hospital. Where there is an approved premises within 500 metres of the proposed premises, there is often insufficient, or no evidence, to demonstrate that those approved premises are in a small or large shopping centre or private hospital as defined under the Pharmacy Location Rules. Applicants are reminded that it is their responsibility to provide such evidence, and that in the absence of such evidence the ACPA may find that the distance requirement is not met and therefore recommend that the application not be approved.
When providing scaled maps or street directory maps, it is important to ensure that all of the relevant premises are clearly identified and labelled, and that a statement of the distance between all of the relevant premises is provided. The scale should also be clearly shown on the map. It is preferable that symbols be used to identify locations rather than colour. Please be aware that the ACPA will generally not rely on evidence of measurements provided by web based mapping tools only.

Applications to relocate within a facility – Rule 122

When considering an application made under Rule 122 – relocation within a facility, the ACPA is required to be satisfied that the proposed premises are the in the same facility as the existing premises. Often there is insufficient or no evidence provided to demonstrate that the proposed and existing premises are in a facility as defined in the Pharmacy Location Rules (small or large shopping centre, private hospital, or large medical centre). It is the applicant’s responsibility to provide sufficient evidence to demonstrate that the building in which the proposed and the existing premises are located satisfy the definition of a facility.

If the building in which the proposed and the existing premises are located do not meet the definition of a facility under the Rules, applicants should instead consider the requirements of Rule 124.

Relocation applications – no evidence regarding whether the current premises are within a facility

One of the requirements for Rule 124 - short distance relocation not more than 1km, is that the ACPA be satisfied that either the existing (current) premises are not in a facility (as defined under the Rules) or that if the existing (current) premises are in a facility, that the proposed (new) premises are at least 500 metres, by straight line, from all approved premises not located in that same facility.


Many applicants are failing to address this requirement, or are instead providing evidence of whether or not the proposed (new) premises are located in a facility. Failure to provide evidence to clearly indicate whether or not the current pharmacy premises are in a facility may result in the ACPA recommending that the application not be approved.

Single management references

A number of Rules include items which require the Authority to be satisfied that a shopping centre or medical centre meets the definition of a facility within the Rules. This requires the Authority to be satisfied, among other things, that the shopping centre or medical centre is under single management. Often a statement is provided that simply refers to the shopping centre or medical centre being “under single management”. However, the ACPA has requested that applicants provide details of the specific elements of single management that are the responsibility of the manager(s).


Last minute applications

Applicants are cautioned against using a ‘just in time’ approach for applying to the ACPA. The ACPA must be satisfied that all criteria applicable to the Rule under which an application has been made, are met. It is therefore not uncommon for a decision to be deferred to the next scheduled meeting to allow the ACPA to seek further evidence from the applicant or third party.

In addition, the ACPA will generally only defer making a decision on an application if a minor point of clarification is required. The ACPA does not defer making a decision at the request of an applicant. It should not be assumed that the ACPA will defer making a decision to seek additional information. In some cases, for example, where more than one issue requires clarification, the ACPA may instead recommend that the application not be approved rather than requesting additional information.

It is therefore in an applicant’s best interests to ensure that evidence is provided in support of all the requirements applicable to the Rule under which the application has been made. Evidence should be relevant to the criteria for which it is being provided, current and up to date, and consistent when included in different pieces of evidence.

Definition of ‘full-time’, ‘the equivalent of’, ‘PBS prescriber’ and ‘medical practitioner’

There continues to be some confusion regarding the establishment of a new pharmacy in a large medical centre and the requirement for demonstrating the required number of PBS prescribers. Item 136(4) requires that the ACPA must be satisfied that, for the two months prior to the day the application is made, and for the two months prior to the day ACPA considers the application, there must be at least eight full-time PBS prescribers, of which at least seven must be prescribing medical practitioners (i.e. general practitioners) practising at the medical centre.


The Explanatory Statement to PB 65 of 2011 defines “full-time” and “the equivalent of”, “PBS prescriber” and “medical practitioner” as follows:

Full-time PBS prescriber (including medical practitioner) means providing the services of a PBS prescriber for at least 38 hours each week. For example, for a medical practitioner, time spent consulting with patients at their home or in hospital is included when calculating the hours that a medical practitioner practises at a medical centre. Time spent consulting at other medical centres, working at a hospital (rostered duties), attending nursing homes and undertaking administration work for the medical centre/practice, such as staff rosters, is not counted towards the time spent practising at the medical centre/practice.

The equivalent of a full-time PBS prescriber means any number of PBS prescribers who provide the equivalent services of one full-time PBS prescriber. For example, if one part-time PBS prescriber practises 20 hours each week and another practises 18 hours each week, then they will be considered the equivalent to one full-time PBS prescriber as their combined practice hours equal 38 hours. Similarly, if one PBS prescriber practises 57 hours each week then they are considered the equivalent to one and a half full-time PBS prescribers.

The Rules do not require that there be eight full-time PBS prescribers practising at the one time for Item 136(4) to be met.

PBS prescriber means a medical practitioner or a participating dental practitioner, or an authorised optometrist, midwife or nurse practitioner.

Medical practitioner means a person registered or licensed as a medical practitioner under a State or Territory law, and does not include a person whose registration or license has been suspended or cancelled. For the purposes of the Rules, the requirements associated with a medical practitioner require that the medical practitioner provides general practice services in the relevant community and issues prescriptions for pharmaceutical benefits.

In calculating the number of PBS prescribers practising at a medical centre, the hours worked by other prescribers or providers of services that are not included in the definition of “PBS prescriber”, such as specialists, are not able to be included.

Provision of meeting outcome advice

The ACPA generally meets monthly to consider applications. The results of meetings are not available until at least the next working day after a meeting. In the first instance, the ACPA Secretariat will, as soon as practicable, advise applicants by email whether or not the ACPA has recommended approval of their application, or whether it has deferred making a recommendation to allow further information to be sought. Details of the decision will not be provided in these emails but rather, will be provided in formal correspondence as outlined below. Please note that the ACPA deals with a large number of applications at each meeting and as such these processes are in place to ensure a fair and consistent approach for all applicants.


Recommendation that an application be approved

If the ACPA has recommended that an application be approved, the application will be returned to the Department of Human Services with notification of the ACPA’s recommendation within two working days after the meeting.


Deferrals

If the ACPA has deferred making a recommendation on an application to allow further information to be sought, the Secretariat will endeavour to write to the applicant within five working days after the meeting.


Recommendation that an application not be approved

If the ACPA has recommended that an application not be approved, the Secretariat will endeavour to write to the applicant within ten working days after the meeting.


Provision of advice to third parties

The Secretariat will not advise third parties who provided comment on an application of the ACPA’s decision until correspondence to the applicants has been finalised. Therefore it is unlikely that third parties will be advised of meeting outcomes until at least 10 working days after a meeting.


Information for third parties

It is important to note that the ACPA is not required or obliged to seek comments from nearby pharmacists when an application for approval to establish a new pharmacy, or relocate an existing, pharmacy has been received. When the ACPA does write to surrounding pharmacies within the area of an application, it cannot guarantee that it will write to all pharmacies who may be interested in commenting on the application. For this reason, it may be in the interest of any pharmacist that receives an invitation for comment, to make sure that other pharmacists in the area are informed, as the ACPA will consider all comments that are received from interested third parties prior to the day an application is considered.


Any comments provided in relation to an application must be made in writing, and should relate to the relevant criteria of the Rules. The ACPA is unable to consider issues, such as commercial matters, that are not within the Rules. Comments should also be substantiated with supporting evidence.
There have been occasions where pharmacists have provided the personal details of their customers when commenting on an application. When providing comments, pharmacists must ensure that they observe their obligations in regards to the collection, use or disclosure of personal and/or health information of individuals. These include ethical and legal obligations to protect the privacy of customers, who have a right to expect that their information will be held in confidence unless information is required to be released by law.

There is no requirement for the disclosure of personal and /or health information of a customer or patient to be released in relation to an application for approval to supply pharmaceutical benefits, or when commenting on an application by another pharmacist.

Meeting dates for 2014-15

The dates for the remaining ACPA meetings for 2014 and the corresponding application lodgement timeframes for complete applications to be received by the Department of Human Services are outlined in the table below. In addition, the dates for meetings for the first half of 2015 have been scheduled. Please note these dates are subject to change and any updates will be published on the
Health website ACPA page.


ACPA Meeting dateTimeframe to lodge an Application with the Department of Human Services
FridayFromTo
26 September 2014Tuesday 22 July 2014Monday 18 August 2014
31 October 2014Tuesday 19 August 2014Monday 22 September 2014
12 December 2014Tuesday 23 September 2014Monday 3 November 2014
23 January 2015Tuesday 4 November 2014Monday 15 December 2014
27 February 2015Tuesday 16 December 2014Monday 19 January 2015
27 March 2015Tuesday 20 January 2015Monday 16 February 2015
1 May 2015Tuesday 17 February 2015Monday 23 March 2015
29 May 2015Tuesday 24 March 2015Monday 20 April 2015
26 June 2015Tuesday 21 April 2015Monday 18 May 2015

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 and for the ACPA to give proper consideration of applications.



Contacting the Secretariat

All enquiries relating to the Pharmacy Location Rules and applications (other than enquiries relating to the lodgement of applications) should be directed to the Secretariat (rather than individual staff members) by either phoning (02) 6289 2419 and leaving your name, contact number and a brief message or emailing your enquiry to the
ACPA mailbox. A member of the Secretariat will respond to your enquiry as soon as possible.

The Secretariat would appreciate that applicants and their agents also use the number or email above rather than contacting members of the Secretariat directly as there is not always someone available to answer such calls.

Applicants and their agents wishing to enquire about the results of a meeting are requested to contact the Secretariat preferably by email or by phoning the number above, and including reference numbers for each application in the message.

Please note: While the Secretariat is able to provide some information regarding the Rules, it is unable to provide advice as to whether a particular scenario would be possible under the Rules or whether or not the ACPA would accept particular evidence. There are a number of factors that may affect a particular scenario, and until the ACPA has assessed an application against the requirements of the Rules, a definitive answer cannot be provided.

Enquiries relating to the lodgement of applications should be directed to a Pharmacy Programme Officer on 132 290 or by emailing the PBS Approvals.

Further information on the Pharmacy Location Rules and the ACPA is available at the ACPA web page.


Pharmacy Location Rules News - April 2014

Printable version of news - April 2014 (PDF 519 KB)

The role of the Australian Community Pharmacy Authority

The Australian Community Pharmacy Authority’s (ACPA’s) role is to consider applications for approval to supply pharmaceutical benefits at particular premises and to make recommendations as to whether or not a pharmacist should be approved. In making its recommendations, the ACPA must comply with the Rules determined by the Minister under section 99L of the National Health Act 1953.

In order to recommend that an application be approved, the ACPA must be satisfied that all of the requirements of the Rule under which the application was made, are met. There may be occasions when the ACPA defers making a recommendation on an application in order to seek clarification of information, but this only occurs in limited circumstances. Applicants should not assume that the ACPA will defer an application that may require additional information.

Important information for applicants

Applicant’s Handbook

A revised version of the Pharmacy Location Rules Applicant’s Handbook is now available. This version is intended to clarify issues that appear to have been causing confusion for applicants, agents and surrounding pharmacists. Many of these issues have been addressed in earlier editions of the Pharmacy Location Rules News.

It is not uncommon for the ACPA to be presented with applications that appear to have been prepared without the advantage of the applicant having consulted the Handbook. Pharmacists interested in making an application are encouraged to consult the Handbook before commencing preparation of an application.

It is recommended that when making an application, the applicant include a covering letter that clearly describes the documentation provided and any circumstances of the application that might be relevant.

It is also recommended that applicants read earlier editions of the Pharmacy Location Rules News which can be found under the ‘News’ page link.

Deferring an application

The ACPA will generally only defer making a recommendation on an application if a minor point of clarification is required. The ACPA does not defer making a recommendation at the request of an applicant.

Where more than one issue requires clarification or further information, the ACPA may recommend that the application not be approved rather than requesting additional information. It is therefore in an applicant’s best interests to ensure that evidence is provided in support of all of the requirements applicable to the Rule under which the application has been made, and that all evidence is relevant to the criteria for which it is being provided, is current and up to date, and consistent across different pieces of evidence. It is the applicant’s role to provide advice about the relevance of the evidence provided.

Reapplying for the same premises

When an applicant reapplies for the same premises, they should review their previous evidence to ensure its currency and determine whether any evidence requires updating. For example, a statutory declaration referring to the number of full time equivalent prescribing medical practitioners may have been current at the date of the earlier application, but will no longer be current for any subsequent application given the timing requirements within the Rules. Applicants should also review their leasing documentation to ensure that any conditions relating to dates and timeframes are still able to be met.

Requests for late applications

Where an applicant wishes to reapply for particular premises due to the ACPA recommending that their earlier application for those premises not be approved, the applicant will be required to observe the usual lodgement dates for ACPA meetings. The ACPA will generally only accept a request for a late application where there are circumstances that are outside the applicant’s control, and where there are no earlier applications in the same area that are yet to be finalised by the ACPA. As all applications have an element of commercial importance, the ACPA does not generally consider commercial circumstances as a reason for accepting a late application.

The Authority is mindful of maintaining a fair and consistent approach for all applicants and not disadvantaging those applicants who observe the application lodgement dates.

Timing of relocation applications

Pharmacists who are nearing the end of their lease or who may be on a month to month lease should be aware that in the event that they are given notice to vacate their existing premises, the timeframes for application lodgement and scheduled meetings may not fit in with the timeframes required by the notice to vacate. Pharmacists are advised to keep this in mind when considering their leasing arrangements and plans to relocate to alternative premises. The meeting dates and application lodgement dates are included in this document, and are published at the ACPA home page.

Evidence of legal right to proposed premises

The ACPA continues to receive unsigned copies of leases or agreements to lease as evidence of an applicant’s legal right to occupy their proposed premises. It is important to note that an unsigned lease or agreement to lease is NOT sufficient to demonstrate legal right and may result in the ACPA recommending that the application not be approved.

Accuracy of information

It is important to ensure that any information provided in relation to an application is accurate and up to date. Giving false or misleading information is a serious offence and if the ACPA or the Department suspects that fraudulent or misleading information has been provided, the application will be referred for investigation. A number of applications identified by the ACPA as containing questionable information are currently being investigated.

In addition, where allegations are made by third parties regarding potential fraud, false information, or a potential breach of State/Territory law, the ACPA will refer such allegations to the relevant body where appropriate.

Distance requirements

As the result of a recent Federal Court decision, the ACPA must now determine that the relevant distance is met, rather than being satisfied based on the balance of the evidence available. For this reason, the ACPA will place greater reliance on survey reports undertaken by licenced or registered surveyors, and which have been undertaken in accordance with the requirements as outlined in the Rules. In certain circumstances, the ACPA may request that an independent survey be obtained by its Secretariat, or alternatively, the ACPA may request that an applicant obtain an additional report should clarification of the evidence already provided be required.

It is not uncommon for the ACPA to be presented with illegible maps, or maps that do not sufficiently identify relevant premises or include statements of distance. In addition, the method of measurement is often not by the correct route. For example, for Rule 124, applicants often provide a measurement of the driving route or the shortest lawful access route rather than the straight line distance, or for Rule 131, a measurement of the driving route rather than the shortest lawful access route. The shortest lawful access route is one generally available to be taken between premises that could reasonably be used by average persons travelling that route. The shortest lawful access route can be by car, walking or any other legal means of travel, or a combination of both, and can include travelling through public land such as parks and reserves. However, it must be one available to most members of the public rather than one catering to persons or groups with specialised needs.

When providing scaled maps or street directory maps, it is important to ensure that all of the relevant premises are clearly identified, and that a statement of the distance between all of the relevant premises is provided. The scale should also be clearly shown. It is preferable that symbols be used to identify locations rather than colour.

The ACPA will generally not rely on measurements provided by web based mapping tools.

References to gross leasable area and distance

When addressing gross leasable area (GLA) and distance requirements, applicants are required to provide evidence and a statement of the actual GLA or distance rather than stating that the GLA or distance is “at least” or “greater than” the required size or distance. Failure to provide evidence of the actual GLA or distance may result in the ACPA recommending that an application not be approved. Evidence should also explicitly state whether or not the GLA includes or excludes loading docks.

References to a supermarket

A number of the Rules include a requirement for a supermarket of a particular size. Some of the Rules require that there is a supermarket of a required size within a certain distance of the proposed premises, while others such as the small or large shopping centre Rules, require that the centre contains a supermarket of a required size.

Rules 133 and 134 (new pharmacy in a facility – small or large shopping centre) require that the shopping centre contains a supermarket of a particular size. In considering this requirement, the ACPA requires evidence to demonstrate that either the supermarket is trading, or if not, that its shelves are being stocked and that trading is imminent.

Rule 130 (new pharmacy at least 1.5km) and Rule 132 (new additional pharmacy at least 10km) require that within a certain distance of, or within the same town as, the proposed premises, there is a supermarket that is the required size, and that it was operating (open and trading) on both the day the application was made and on the day the ACPA considers the application. For Rules 130 and 132, it is not sufficient to demonstrate that a supermarket has signed a lease for premises, or that building of the supermarket has commenced, or that it is anticipated to be open by the date of the meeting, or at a later date.

An application is taken to be made on the day it is registered by the delegate of the Secretary in the Department of Human Services. If the supermarket is a new supermarket, and opens on the day the application is made, regardless of the specific time that the supermarket opened to the public, then the Authority may be satisfied that this criteria is met.

Definition of a supermarket

The Secretariat regularly receives enquiries regarding the type of business that constitutes a supermarket.
A supermarket is defined as meaning:

“a retail store or market the primary business of which is the sale of a range of food, beverages, groceries and other domestic goods. Reference to a range of food, beverages, groceries and domestic goods means that it is the type of store in which a person could do their weekly shopping from fresh food (e.g. dairy, meat, bread), pantry items, cleaning products, personal care items and other household staples (e.g. laundry pegs, plastic food wrap). Reference to the primary business means that the definition would not extend to a department or variety store that has a deli or café section, nor does it include a farmer’s market selling a range of produce.”

A supermarket does not mean more than one business operating as a supermarket or market type store.

Applications to establish a new pharmacy in a large medical centre


The requirements of Rule 136 (new pharmacy in a large medical centre) include that the ACPA be satisfied that, at all relevant times, the number of PBS prescribers at the medical centre is equivalent to at least 8 full time PBS prescribers, of which at least 7 PBS prescribers must be prescribing medical practitioners.

‘At all relevant times’ means:
  • on the day the application made, being the day the application was registered by the Department of Human Services; and
  • for each week in the 2 months before the day the application was made; and
  • for each week in the 2 months before the day the application is considered by the ACPA.

While the ACPA recognises that this is an onerous task for medical centres to provide information regarding the hours worked by PBS prescribers, it needs to be recognised and accepted that this is a requirement which must be met, in order for the ACPA to recommend that an application be approved. Copies of rosters of the actual hours worked by each PBS prescriber for each and every week in the 2 months before the day on which the application was made, should be provided.

Many applicants fail to provide information in relation to the 2 months before the day the application was made, or to provide updated information in the event that they make a new application for the same site.

In most cases, the Secretariat, on behalf of the ACPA, will contact the medical centre directly in the week leading up to the meeting at which the application is to be considered, to request information in relation to the 2 months before the meeting day on which the application is to be considered by the ACPA (but not the 2 months prior to the date of the application being made). If the application is deferred to allow further evidence to be sought for any of the requirements, this process will be repeated.

Definition of ‘full-time’, ‘the equivalent of’, ‘PBS prescriber’ and ‘medical practitioner’

The Explanatory Statement to PB 65 of 2011 defines “full-time” and “the equivalent of”, “PBS prescriber” and “medical practitioner” as follows:

Full-time PBS prescriber (including medical practitioner) means providing the services of a PBS prescriber for at least 38 hours each week. For example, for a medical practitioner, time spent consulting with patients at their home or in hospital is included when calculating the hours that a medical practitioner practises at a medical centre. Time spent consulting at other medical centres, working at a hospital (rostered duties), attending nursing homes and undertaking administration work for the medical centre/practice, such as staff rosters, is not counted towards the time spent practising at the medical centre/practice.

The equivalent of a full-time PBS prescriber means any number of PBS prescribers who provide the equivalent services of one full-time PBS prescriber. For example, if one part-time PBS prescriber practises 20 hours each week and another practises 18 hours each week, then they will be considered the equivalent to one full-time PBS prescriber as their combined practice hours equal 38 hours. Similarly, if one PBS prescriber practises 57 hours each week then they are considered the equivalent to one and a half full-time PBS prescribers.

PBS prescriber means a medical practitioner or a participating dental practitioner, or an authorised optometrist, midwife or nurse practitioner.

Medical practitionerThe term medical practitioner, as it appears in the Rules, means a person registered or licensed as a medical practitioner under a State or Territory law, and does not include a person whose registration or license has been suspended or cancelled. It is distinct from the term prescribing medical practitioner, which is defined in the Rules to mean a medical practitioner who provides general practice services to the community in which he or she practises, including the issuing of prescriptions for pharmaceutical benefits. Not all medical practitioners will be prescribing medical practitioners for the purposes of the Rules.

In calculating the number of prescribing medical practitioners practising at a medical centre, the hours worked by other prescribers or providers of services that are not included in the definition, such as specialists who are not providing general practice services to the community in which they practise, are not able to be included.

Ancillary pharmacy approval and evidence of accessibility to the public at large

One of the general requirements for all applications to relocate an existing or establish a new pharmacy, is that the proposed premises could be used for the operation of a pharmacy under applicable local government and State or Territory laws relating to land development, and that the premises would be accessible by members of the public at large.

It is not uncommon for an ‘ancillary’ pharmacy or dispensary to be approved by the local council, particularly when approving the development of a medical centre. Often the Council intends that the ‘ancillary’ nature of the pharmacy or dispensary approval restricts the use of the pharmacy to patients of the medical centre. For this reason, in particular with applications made under Rule 136 (new pharmacy in a large medical centre), applicants are required to demonstrate not only that a pharmacy is a permissible use at the proposed premises, but also that the Council has not placed any restrictions on who may access the pharmacy.

Statutory Declarations

Statutory declarations are commonly provided as part of the evidence included in an application. A statutory declaration is a written statement that allows a person to declare something to be true.
As an application for pharmacy approval is made to a Commonwealth Department, statutory declarations should be made on a Commonwealth of Australia statutory declaration template, and be signed in the presence of an authorised witness. Care should be taken to ensure that the statutory declaration is correctly made, including being signed and dated by the person making the declaration and the authorised witness. The ACPA has previously received declarations that have not included the details of the person making the declaration, and therefore the ACPA has not been able to establish the capacity in which the person has made the declaration. Others have included the incorrect date (being a date in the future), and in one case, a declaration had been signed by an authorised witness despite not having been signed by the person making the declaration.

Information on Commonwealth statutory declarations, including templates and information on authorised witnesses, is available at the Attorney-General's website.

Information for third parties

It is important to note that the ACPA is not required or obliged to seek comments from nearby pharmacists when an application for approval to establish a new, or relocate an existing, pharmacy has been received. When the ACPA does write to surrounding pharmacies within the area of an application, it cannot guarantee that it will write to all pharmacies who may be interested in commenting on the application. For this reason, it may be in the interest of any pharmacist that receives an invitation for comment, to make sure that other pharmacists in the area are informed, as the ACPA will consider all comments that are received from interested third parties prior to the day an application is considered.

Any comments provided in relation to an application must be made in writing, and should relate to the relevant criteria of the Rules. The ACPA is unable to consider issues, such as commercial matters, that are not within the Rules. Comments should also be substantiated with supporting evidence.

There have been occasions where pharmacists have provided the personal details of their customers when commenting on an application. When providing comments, pharmacists must ensure that they observe their obligations in regards to the collection, use or disclosure of personal and/or health information of individuals. These include ethical and legal obligations to protect the privacy of customers, who have a right to expect that their information will be held in confidence unless information is required to be released by law.

There is no requirement for the disclosure of personal and /or health information of a customer or patient to be released in relation to an application for approval to supply pharmaceutical benefits, or when commenting on an application by another pharmacist.

Meeting dates for 2014

The ACPA meeting dates for 2014 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 and any updates will be published on the ACPA home page.


ACPA Meeting date - FridayTimeframe to lodge an Application with the Department of Human Services - FromTimeframe to lodge an Application - To
28 March 2014Tuesday 21 January 2014Monday 17 February 2014
2 May 2014Tuesday 18 February 2014Monday 24 March 2014
30 May 2014Tuesday 25 March 2014Tuesday 22 April 2014
27 June 2014Wednesday 23 April 2014Monday 19 May 2014
25 July 2014Tuesday 20 May 2014Monday 16 June 2014
29 August 2014Tuesday 17 June 2014Monday 21 July 2014
26 September 2014Tuesday 22 July 2014Monday 18 August 2014
31 October 2014Tuesday 19 August 2014Monday 22 September 2014
12 December 2014Tuesday 23 September 2014Monday 3 November 2014
23 January 2015Tuesday 4 November 2014Monday 15 December 2014

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 and for the ACPA to give proper consideration of applications.


Lodging an application to establish a new pharmacy or relocate an existing pharmacy

Complete applications for approval to supply pharmaceutical benefits under section 90 of the National Health Act 1953 should be lodged by email to the NSW PBS Approvals Clerk.

Applications lodged to the Department of Human Services cannot exceed 100 Mb including all attachments. For assistance or for more information contact a Pharmacy Programme Officer on 132 290.

Contacting the Secretariat

All enquiries relating to the Pharmacy Location Rules and applications (other than enquiries relating to the lodgement of applications) should be directed to the Secretariat (rather than individual staff members) by either phoning (02) 6289 2419 and leaving your name, contact number and a brief message or emailing your enquiry to the ACPA email address. A member of the Secretariat will respond to your enquiry as soon as possible.

Applicants and their agents wishing to enquire about the results of a meeting are requested to contact the Secretariat preferably by email or by phoning the number above, and including reference numbers for each application in the message.

Please note: While the Secretariat is able to provide some information regarding the Rules, it is unable to provide advice as to whether a particular scenario would be possible under the Rules or whether or not the ACPA would accept particular evidence. There are a number of factors that may affect a particular scenario, and until the ACPA has assessed an application against the requirements of the Rules, a definitive answer cannot be provided.
Enquiries relating to the lodgement of applications should be directed to a Pharmacy Programme Officer on 132 290 or by emailing nsw.pbs.approval.clerk@humanservices.gov.au.
Further information on the Pharmacy Location Rules and the ACPA is available on the ACPA home page.

Pharmacy Location Rules News - September 2013

Printable version of news - September 2013 (PDF 541 KB)

Meeting dates for 2014

The ACPA meeting dates for 2014 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 and any updates will be published on the website at the ACPA web page.

Timeframe to lodge an Application with the Department of Human Services

ACPA Meeting date (Friday)
    From
    To
6 December 2013
    Tuesday 24 September 2013
    Monday 28 October 2013
24 January 2014
    Tuesday 29 October 2013
    Monday 16 December 2013
28 February 2014
    Tuesday 17 December 2013
    Monday 20 January 2014
28 March 2014
    Tuesday 21 January 2014
    Monday 17 February 2014
2 May 2014
    Tuesday 18 February 2014
    Monday 24 March 2014
30 May 2014
    Tuesday 25 March 2014
    Tuesday 22 April 2014
27 June 2014
    Wednesday 23 April 2014
    Monday 19 May 2014
25 July 2014
    Tuesday 20 May 2014
    Monday 16 June 2014
29 August 2014
    Tuesday 17 June 2014
    Monday 21 July 2014
26 September 2014
    Tuesday 22 July 2014
    Monday 18 August 2014
31 October 2014
    Tuesday 19 August 2014
    Monday 22 September 2014
12 December 2014
    Tuesday 23 September 2014
    Monday 3 November 2014
23 January 2015
    Tuesday 4 November 2014
    Monday 15 December 2014

    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 and for the ACPA to give proper consideration of applications.

    Reduced activity during the 2013 Christmas period

    The Department of Human Services, and the Department of Health (in which the Secretariat for the ACPA is located) will be closed between Christmas day and New Years day. Information regarding lodgement of applications during this period will be available on the Department of Human Services’ website.

    Lodging an application to establish a new pharmacy or relocate an existing pharmacy

    During May 2013 the Department of Human Services made an administrative change to the lodgement process for applications for approval to supply pharmaceutical benefits under section 90 of the National Health Act 1953.
      Complete applications should be lodged by email to the NSW PBS Approvals Clerk.

      Applications lodged to the Department of Human Services cannot exceed 100 Mb of the email including all attachments. For assistance or for more information contact a Pharmacy Program Officer on 132 290

      Notification of meeting outcomes

      The ACPA’s Secretariat has implemented a new procedure to notify applicants of the outcomes of the ACPA’s meetings. In the week following the meeting, the Secretariat will email applicants or their authorised representative, to advise them of the ACPA’s decision. This email will not include details of the decision, which will be included in the correspondence which will follow within the timeframe outlined in the email.

      Provision of information to the ACPA, the Department of Health and the Department of Human Services

      A recent application to establish a new pharmacy, which was recommended for approval by the ACPA, was subsequently referred to the Department of Health’s Audit and Fraud Branch for assessment of possible fraud against the Commonwealth, based on information contained in a Commonwealth Statutory Declaration which had been included with the application.

      The application became the subject of a Federal Court appeal, in part due to an allegation that the decision of the ACPA was infected with fraud, in particular, that the statutory declaration, relied upon by the ACPA in reaching its decision, was misleading.

      Applicants are reminded that they have an obligation to ensure that all information contained in an application, to establish a new pharmacy or relocate an existing pharmacy, is accurate and up to date.

      If the ACPA or either the Department of Health or the Department of Human Services suspects that evidence provided in support of an application is fraudulent, the matter will be referred for possible investigation.

      Quality and volume of evidence

      In addition, to avoid unnecessary delays it is in the best interests of applicants to ensure that any evidence submitted with an application is relevant to the criteria for which it is being provided, and that it is current and up to date.

      Care should also be taken to ensure consistency is maintained across submitted evidence for issues such as the applicant’s name(s) and addresses of proposed premises that may appear on several pieces of evidence.In providing evidence, it is the applicant’s responsibility to summarise the evidence, draw conclusions from the material and clearly identify how the relevant requirements of the Rules are met by the evidence. It is useful for the ACPA if a summary is provided for each requirement of the Rule under which the application has been made, and the evidence that has been provided in support of each requirement. It is not the ACPA’s responsibility to examine and extract information from large volumes of information and identify how it satisfies the requirements.

      It is also preferable that evidence is provided in black and white rather than colour, and where possible, the use of symbols rather than colour be used on maps, plans and other relevant documents.

      Requests from the ACPA for additional information

      Where the ACPA has requested additional information from an applicant, it is in the applicant’s best interests to ensure that information provided in response is consistent with the ACPA’s request, rather than providing alternative information.

      Last minute applications

      Applicants are cautioned against using a ‘just in time’ approach for applying to the ACPA. The ACPA must be satisfied that all criteria applicable to the Rule under which an application has been made, are met. It is therefore not uncommon for a decision to be deferred to the next scheduled meeting to allow the ACPA to seek further evidence from the applicant or third party.

      Applications made by trusts

      An application for approval to supply pharmaceutical benefits cannot be made in the name of a trust only, but instead a pharmacist or body corporate qualified to provide pharmacy services, must be the trustee for the trust (for example, ‘Joe Bloggs ATF the Bloggs Trust’ or ‘J Bloggs Pty Ltd ATF the Bloggs Trust’).

      Where an application is made by a body corporate or a company as the trustee for a trust, evidence such as a copy of an Australian Securities and Investment Commission (ASIC) record that indicates who the directors of the body corporate or company are, must be provided. The name in which the application is made must also be consistent on any relevant evidence provided in support of the application, in particular, evidence of the applicant’s legal right to the proposed premises.

      It is important that the name nominated on the ‘Applying for approval to supply pharmaceutical benefits at a particular premises’ form is identical to the information supplied to the state pharmacy authority responsible for the registration of pharmacy premises, as the Department of Human services will confirm the details before granting approval. Where there are anomalies in the names, this may cause delays or result in an approval not being granted.

      Restrictions on pharmacies relocating

      The Rules specify the restrictions that apply to certain applications to relocate an existing approval. It is important to note that some of the restrictions under the previous rules continue to apply for the period specified in that restriction. For example, an approval granted as a result of an application made under Rule 113 of the previous rules cannot relocate to premises more than 1.5 km in a straight line from the premises in respect of which the approval was originally granted, for a period of 5 years.

      An application to relocate an approval that was originally granted under the current Rule 133 (small shopping centre) or Rule 134 (large shopping centre) is unable to relocate out of that centre for a period of 10 years, unless the ACPA is satisfied that there are exceptional circumstances.

      When referring an application to the ACPA, the Department of Human Services will provide information to the ACPA in relation to any relevant restrictions that apply to the existing approval.

      Requirement for pharmacists to observe privacy obligations of individuals

      There have been occasions where pharmacists have provided the personal details of their customers when providing comments on an application as a surrounding pharmacist.

      Pharmacists should ensure that when providing evidence, they observe their obligations in regards to the collection, use or disclosure of personal and / or health information of individuals. These include ethical and legal obligations to protect the privacy of customers, who have a right to expect that their information will be held in confidence unless information is required to be released by law.

      There is no requirement for such information to be released in relation to an application for approval to supply pharmaceutical benefits, or when commenting on an application by another pharmacist.

      Ancillary pharmacy approval and evidence of accessibility to the public at large

      One of the general requirements for all applications to relocate an existing or establish a new pharmacy, is that the proposed premises could be used for the operation of a pharmacy under applicable local government and State or Territory laws relating to land development, and that the premises would be accessible by members of the public at large.

      It is not uncommon for an ‘ancillary’ pharmacy or dispensary to be approved by the local council, particularly when approving the development of a medical centre. Often the Council intends that the ‘ancillary’ nature of the pharmacy or dispensary approval restricts the use of the pharmacy to patients of the medical centre. For this reason, in particular with applications made under Rule 136 (new pharmacy in a large medical centre), applicants are required to demonstrate not only that a pharmacy is a permissible use at the proposed premises, but also that the Council has not placed any restrictions on who may access the pharmacy.

      Applications to establish a new pharmacy in a large medical centre

      The requirements of Rule 136 (new pharmacy in a large medical centre) include that the ACPA be satisfied that, at all relevant times, the number of PBS prescribers at the medical centre is equivalent to at least 8 full time PBS prescribers, of which at least 7 PBS prescribers must be prescribing medical practitioners.

      ‘At all relevant times’ means:
      • on the day the application made, being the day the application was registered by the Department of Human Services; and
      • for each week in the 2 months before the day the application was made; and
      • for each week in the 2 months before the day the application is considered by the ACPA.
      While the ACPA recognises that this is an onerous task for medical centres to provide information regarding the hours worked by PBS prescribers, it needs to be recognised and accepted that this is a requirement that the ACPA must be satisfied is met, in order to recommend that an application be approved. Copies of rosters of the actual hours worked by each PBS prescriber for each and every week in the 2 months before the day on which the application was made, should be provided.

      Many applicants fail to provide information in relation to the 2 months before the day the application was made, or to provide updated information in the event that they make a new application for the same site.

      The Secretariat, on behalf of the ACPA, will contact the medical centre directly in the week leading up to the meeting at which the application is to be considered, to request information in relation to the 2 months before the day the application is considered by the ACPA. If the application is deferred to allow further evidence to be sought for any of the requirements, this process will be repeated.

      Statutory Declarations

      Statutory declarations are commonly provided as part of the evidence included in an application. A statutory declaration is a written statement that allows a person to declare something to be true.

      As an application for pharmacy approval is made to a Commonwealth Department, statutory declarations should be made on a Commonwealth of Australia statutory declaration template, and signed in the presence of an authorised witness.

      Information on Commonwealth statutory declarations, including templates and information on authorised witnesses, is available at the Attorney-General’s Department web page.

      Contacting the Secretariat

      All enquiries relating to the Pharmacy Location Rules and applications (other than enquiries relating to the lodgement of applications) should be directed to the Secretariat (rather than individual staff members) by either phoning (02) 6289 2419 and leaving your name, contact number and a brief message or emailing your enquiry to the ACPA inbox. A member of the Secretariat will respond to your enquiry as soon as possible.

      Applicants and their agents wishing to enquire about the results of a meeting are requested to contact the Secretariat preferably by email or by phoning the number above, and including reference numbers for each application in the message.

      Please note: While the Secretariat is able to provide some information regarding the Rules, it is unable to provide advice as to whether a particular scenario would be possible under the Rules or whether or not the ACPA would accept particular evidence. There are a number of factors that may affect a particular scenario, and until the ACPA has assessed an application against the requirements of the Rules, a definitive answer cannot be provided.

      Enquiries relating to the lodgement of applications should be directed to a Pharmacy Program Officer on 132 290 or by emailing NSW PBS Approvals Clerk.

      Further information on the Pharmacy Location Rules and the ACPA is available at the ACPA web page.

      Pharmacy Location Rules News - May 2013

      Printable version of news - May 2013 (PDF 472 KB)

      Lodging an application to establish a new pharmacy or relocate an existing pharmacy

      During May, the Department of Human Services (Medicare) will make an administrative change to the lodgement process for applications for approval to supply pharmaceutical benefits under section 90 of the National Health Act 1953.

      Complete applications should be lodged by email to the NSW PBS Approvals Clerk:

      Applications lodged to the Department of Human Services cannot exceed 100 Mb of the email including all attachments

      or

      for more information contact a Pharmacy Program Officer on 132 290.

      Changes to the types of evidence accepted by the Authority

      Distance requirements

      Most applications for approval to supply pharmaceutical benefits under section 90 of the National Health Act 1953, which are to be considered by the Authority, require evidence regarding the distance requirements of the Pharmacy Location Rules.

      The Authority has identified potential inaccuracies with web based mapping measurement tools. Therefore, depending on the specifics of each application, the Authority may no longer rely on such evidence provided in support of distance requirements. To avoid potential delays in a decision being made on an application, applicants may instead wish to provide evidence such as a scaled map or scaled street directory map, highlighting and identifying all of the relevant premises, and including a statement of the distance between all of the relevant premises.

      If the distance is near to the required distance, it is advisable that a survey report of the measurement, undertaken by a licensed or registered surveyor, be provided. The Pharmacy Location Rules Applicant’s Handbook outlines the elements that should be included and stated in a survey report.

      Applicants are also reminded to provide the measurement as required by the particular Rule under which the application has been made. In most cases, the Rules require that the distance be measured by straight line, and the Authority will not accept a distance that has been measured by other routes such as the shortest lawful access route or driving routes.

      Statutory Declarations

      Statutory Declarations are commonly provided as part of the evidence included in an application. A statutory declaration is a written statement that allows a person to declare something to be true. As an application for pharmacy approval is made to a Commonwealth Department, statutory declarations should be made on a Commonwealth of Australia statutory declaration template, and signed in the presence of an authorised witness.

      For information on Commonwealth statutory declarations, including templates and information on authorised witnesses, go to the Attorney-General's website. Top of page

      Common issues with applications

      There are a number of common issues with applications, including applicants providing no evidence to address one or more requirements or the inclusion of incomplete evidence. The Authority is unable to determine whether or not a particular requirement is met without relevant evidence being included in the application, even if it appears obvious. If there is no or insufficient evidence to support a requirement, the Authority may not be satisfied the requirement has been met and would be unable to recommend that an application be approved.

      Failure to address a requirement may result in the Authority deferring making a recommendation on the application to allow further information to be requested, or the Authority recommending that the application not be approved.

      a) The most common examples of issues with the requirements for all applications are outlined below:

      No evidence that the applicant will be ready to trade within six months of a recommendation being made by the Authority

      The Authority has noted that applicants are commonly failing to provide any evidence to address this requirement.

      Evidence to address the readiness to trade within six month requirement may include:
      • plans that have already been approved by the relevant local Council;
      • a building or fit-out schedule that indicates works will be completed by a certain date;
      • photographs demonstrating the proposed premises are already established or to demonstrate progress with building and that the building needs little work in order to be made ready. Please note that the date the photograph was taken should be included on the photograph.

      No evidence that the proposed premises are not directly accessible by the public from within a supermarket

      The Authority has noted that applicants are commonly failing to provide any evidence to address this requirement.

      Evidence to address that the proposed premises are not directly accessible by the public from within a supermarket may include:
      • a scaled, computer generated or drafted (not hand drawn) site plan of the proposed premises and any adjacent or joining premises, highlighting the public access points to the proposed pharmacy and any supermarkets within the same complex, and including information about the type of adjacent or joining premises.

      Insufficient evidence of legal right to proposed premises

      The Authority regularly receives unsigned copies of leases or agreements to lease as evidence of an applicant’s legal right to their proposed premises. It is important to note that an unsigned lease or agreement to lease is not sufficient to demonstrate legal right and may result in the Authority recommending that the application not be approved.

      Where the applicant is sub-leasing the premises, there is often no evidence provided to demonstrate that the head lease permits sub-leasing, and/or that the head lessor has consented to the sub-lease.

      Insufficient identification of proposed premises

      The Authority regularly receives poorly drawn floor plans which do not include any details regarding the address of the proposed premises or any other information to assist the Authority in identifying the location of the proposed premises.

      The Authority is required to have a clear understanding of the location of the proposed premises. Therefore a scaled, drafted (not a hand drawn sketch) site and floor plan of the proposed premises should be provided. The plan should identify the full address of the proposed premises, including full details of specific street names, numbers and suburbs as well as any relevant shop, floor, suite or lot numbers, and highlighting the public access points to the proposed pharmacy. Any adjacent or joining premises should also be identified.

      b) In addition, the most common examples of issues with requirements which are applicable to applications to relocate an existing pharmacy are outlined below:

      Relocation applications - no evidence regarding whether the current premises are within a facility

      One of the requirements of the short distance relocation Rule 124 is that the Authority be satisfied that either the existing (current) premises are not in a facility (as defined under the Rules) or that if the existing (current) premises are in a facility, that the proposed (new) premises be at least 500m, by straight line, from all approved premises not located in that same facility.

      Many applicants are failing to address this requirement, or are instead providing evidence of whether the proposed (new) premises are located in a facility or not.

      Please refer to the Handbook for further information on these requirements.

      Relocation within a facility

      The Authority has been required to recommend that a number of applications made under Rule 122 – Relocation within a facility, not be approved. The common reason for the applications not meeting the requirements of Rule 122 has been that the existing and the proposed premises have not been in a facility as defined by the Rules.

      A facility is defined as a small or large shopping centre, a large medical centre or a private hospital, definitions of which are also included in the Rules. If the centre or hospital in which the premises are located does not meet the definition in the Rules, the Authority is unable to recommend approval.

      Applicants may wish to consider instead applying under Rule 124 – short distance relocation.

      Contacting the Secretariat

      All enquiries relating to the Pharmacy Location Rules and applications (other than enquiries relating to the lodgement of applications) should be directed to the Secretariat (rather than individual staff members) by either phoning (02) 6289 2419 and leaving your name, contact number and a brief message or emailing your enquiry to the ACPA mailbox. A member of the Secretariat will respond to your enquiry as soon as possible.

      The Secretariat would appreciate that applicants and their agents also use the number or email above rather than contacting members of the Secretariat directly.

      Applicants and their agents wishing to enquire about the results of a meeting are requested to contact the Secretariat preferably by email or by phoning the number above, and including reference numbers for each application in the message.

      Please note: While the Secretariat is able to provide some information regarding the Rules, it is unable to provide advice as to whether a particular scenario would be possible under the Rules or whether or not the Authority would accept particular evidence. There are a number of factors that may affect a particular scenario, and until the Authority has assessed an application against the requirements of the Rules, a definitive answer cannot be provided.

      Enquiries relating to the lodgement of applications should be directed to a Pharmacy Program Officer on 132 290 or by sending an email to the NSW PBS Approvals Clerk.