Australian Community Pharmacy Authority Applicant's Handbook
The Application Process
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When must a pharmacist seek approval
Whether a pharmacist is simply taking on a new partner for an existing pharmacy, or seeking to open a new pharmacy, the pharmacist must apply for approval under section 90 of the Act. If a pharmacist fails to obtain the necessary approval, any payments received from the Commonwealth Government for the supply of pharmaceutical benefits may need to be returned.A pharmacist MUST apply for approval:
- to open a new pharmacy;
- to relocate an existing pharmacy;
- to expand or contract the size of an existing pharmacy;
- to change the address of an existing pharmacy, even if the premises have simply been renumbered and the premises remain unchanged; or
- to change the ownership of an existing pharmacy, including changes resulting from the death of an owner.
A pharmacist DOES NOT need to apply for approval:
- to make internal changes to an existing pharmacy;
- to alter the public access points of an existing pharmacy; or
- if pharmaceutical benefits will not be supplied from the pharmacy.
The Secretary is not required to refer all applications for approval to the ACPA. The only applications which must be referred to the ACPA are applications for the relocation of an existing pharmacy or the establishment of a new pharmacy.
Applications relating to an expansion or a contraction in the size of a pharmacy are not required to be referred to the ACPA, however in some circumstances the Secretary may consider it appropriate to do so. In this case, the application would be considered by the ACPA against the relevant requirements of the pharmacy location rules.
This Handbook deals only with those applications for approval that are referred to the ACPA, that is, applications to establish a new pharmacy, to relocate an existing pharmacy or (if applicable) to expand or contract the size of an existing pharmacy.
All other applications for approval are dealt with by the Secretary and are not considered against the requirements of the pharmacy location rules.
Please note: If a pharmacist has failed to advise Medicare Australia of any change to their circumstances, there is a risk that the pharmacist will have to repay benefits paid to them by the Commonwealth.
If any pharmacist is in any doubt as to whether they need to obtain approval for a certain change to their pharmacy, they should contact Medicare Australia or the ACPA Secretariat.
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Overview
The process begins when a pharmacist makes an application for approval to supply pharmaceutical benefits in respect of particular premises.Top of page
1. What constitutes an application
The National Health (Pharmaceutical Benefits) Regulations 1960 provide that an application for approval must be made using the approved form. From 1 July 2006, the approved form includes certain documents and information. If these are not provided, an application will not be considered valid.
A valid application must include:
- a complete and signed section 90 application form that nominates the pharmacy location rule under which the application is made;
- evidence that the applicant has a legal right to occupy the proposed premises;
- a floor plan of the proposed premises
- evidence that the proposed premises can be used for the purpose of operating a pharmacy;
- a declaration regarding whether the proposed premises are accessible from within a supermarket;
- evidence relating to the relevant distance (not required for an application made under Rule 101, 110 or 111); and
- evidence of when the applicant will commence trading at the proposed premises.
For ease of reference, application form describes the documents which must be included in an application in order for it to be considered valid.
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2. Different types of applications
It is up to the pharmacist to decide which pharmacy location rule he/she will apply under. Each rule sets out different requirements so it is the pharmacist’s responsibility to select the rule which best suits their situation. In addition to the mandatory application requirements described in item 1 above, an application will need to include additional evidence addressing the specific requirements of the nominated rule.The rules that relate to the relocation of an existing pharmacy are:
- Rule 101: Relocation within shopping centre or private hospital
- Rule 102: Relocation within rural locality
- Rule 104: Short distance relocation (up to 1 km)
- Rule 105: Short distance relocation (between 1 km and 1.5km)
- Rule 106: Long distance relocation
- Rule 107: Relocation to rural locality (additional pharmacy)
- Rule 108: Relocation to urban locality (additional pharmacy)
- Rule 109: Relocation to small shopping centre
- Rule 110: Relocation to large shopping centre
- Rule 111: Relocation to private hospital
- Rule 112: Relocation to large medical centre
- Rule 113: New pharmacy (urban locality)
- Rule 114: New pharmacy (rural locality)
- Rule 103: Expansion or contraction
3. Representation
If another person is making an application for approval on behalf of a pharmacist, the application must include written authority by the pharmacist for that person to act on his/her behalf. If written authority is not provided, neither the ACPA Secretariat nor Medicare Australia will be able to discuss the application with the representative.4. Accuracy of information
It is important to ensure that any information that is provided in relation to an application is accurate and up-to-date. Giving false or misleading information is a serious offence under Division 137 of the Criminal Code 1995, the maximum penalty for which is imprisonment for 12 months.5. Practicalities
Following these simple points will ensure that an application is processed as promptly as possible.- Make sure the application form has been completed clearly and has been signed by each applicant. If the application involves another pharmacist’s existing pharmacy approval, ensure that each approved pharmacist has also signed the form.
- Make sure a particular rule has been nominated.
- Include a covering letter that clearly describes the documentation provided and any circumstances of the application that might be relevant.
- In providing evidence, it is the applicant’s responsibility to summarise the material, draw conclusions from the material and clearly identify how the relevant requirements of the pharmacy location rules are met by the evidence. It is not the ACPA’s responsibility to examine large volumes of information and identify how it satisfies the requirements.
- Clearly label any attachments or maps.
- In providing marked-up maps or plans, use symbols rather than colours. This ensures that the ACPA Secretariat can properly duplicate the application for the purposes of ACPA consideration.
- Ensure that any maps provided are clearly scaled and the source of the map is cited.
- Any survey reports should be on the surveyor’s letterhead, and signed and dated by the surveyor.
- If an applicant has engaged the assistance of another person/company in making an application, they must provide written authorisation that the person/company can act on their behalf in all matters relating to the application.
- Above all, ensure that the application clearly addresses each and every one of the relevant requirements of the pharmacy location rules.
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6. Lodging an application
Applications should be lodged with the relevant state office of Medicare Australia at:- PBS Approval Clerk
GPO Box 9826
in your capital city
7. Receipt of a valid application
Upon receipt of an application, Medicare Australia will check that the application is valid, that is, it includes all of the required information.If the application is not valid, Medicare Australia will advise the applicant of the reasons, and will not take any further action in relation to the application unless the applicant provides the missing information.
If the application is valid, Medicare Australia will advise the applicant, in writing, of the receipt of the application and its relevant registration number. The application will then be referred to the ACPA.
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8. Opportunity for nearby pharmacists to provide comment
Once an application has been referred to the ACPA, it is standard practice for the ACPA to seek comments from other pharmacists in the vicinity of the proposed pharmacy. This practice applies to nearly all types of applications.The ACPA is not required or obliged to seek comments from nearby pharmacists, or to advise pharmacists that an application for approval has been made. However, this practice of seeking comments allows other pharmacists the opportunity to comment on whether, in their opinion, the proposed pharmacy would meet the requirements of the pharmacy location rules. It is also informative for the ACPA to obtain information from persons other than the applicant, who have specialised knowledge of a particular area. Pharmacists will generally be given two weeks to respond.
The ACPA cannot guarantee that it will write to all pharmacists who might be affected by an application for approval. It may be in the interest of any pharmacist that receives an invitation for comment to make sure other pharmacists in the area are informed and have the opportunity to comment.
Any comments must be made in writing to the ACPA and should relate to the relevant criteria of the pharmacy location rules. Giving false or misleading information is a serious offence under Division 137 of the Criminal Code 1995, the maximum penalty for which is imprisonment for 12 months.
Once the ACPA has made a recommendation in respect of an application, the ACPA will write to any pharmacist that provided comments on that application to advise the outcome. It should be noted that if an ACPA recommendation is subsequently the subject of an appeal to the Administrative Appeals Tribunal (AAT) or a Federal Court, the ACPA will only advise pharmacists, who provided comment on the application, of the appeal.
The details of any comments, including the pharmacist that made the comments, will not be disclosed to the applicant or any other party. However, it is important to note that if the ACPA’s recommendation is the subject of a review by the AAT or a Federal Court, then any comments provided on that application will be released to the applicant and the AAT or court. Further, any comments provided on an application may have to be released under the Freedom of Information Act 1982.
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9. Length of the application process
The ACPA meets once a month to consider applications. It is important to note that there are application cut-off dates in respect of each ACPA meeting (approximately five weeks prior to the meeting). This allows for the ACPA to ensure that the applicant has provided all of the necessary documentation, and that nearby pharmacists are given the opportunity to comment on the application.In considering an application, the ACPA might find that certain information needs to be clarified, or that additional information is necessary. In this case, the ACPA may defer its consideration until a subsequent meeting and request, in writing, that the applicant or another party provide the requested information by a specified date.
If more than one application is received in respect of a particular area, the ACPA will generally consider applications in the order in which they have been received by Medicare Australia, and not at the same meeting. Also, the ACPA will only consider the next application for a particular area once it has made a recommendation in respect of the first application for that area. This means that there might be a delay of several months before a second application for a particular area is considered.
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10. Providing further information
Due to the considerable amount of information considered by the ACPA at each meeting, applicants should ensure that any information they provide is provided no less than five working days before the relevant meeting.Alternatively, if the ACPA defers consideration of an application and requests that the applicant provide further information in support of an application, the ACPA will specify the date by which that information needs to be provided.
Applicants should be aware that the late provision of information may result in the ACPA deferring its consideration of the application, or recommending rejection.
11. ACPA recommendations
Once the ACPA has made a recommendation in respect of an application as to whether or not the applicant be approved, the ACPA will advise Medicare Australia in writing (usually within two working days).If the ACPA has recommended that the pharmacist not be approved, the ACPA will also advise the applicant, in writing, of this decision.
As noted in item 8 above, the ACPA will also write to any pharmacist that provided comments on an application of the outcome.
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12. Reasons for decisions
The applicant may seek from the ACPA a statement of reasons for a recommendation if they are adversely affected by the decision.A request for a statement of reasons must be made, in writing, to the ACPA within 28 days of the date of receiving notification of the ACPA’s recommendation. Upon receipt of a request, the ACPA has 28 days in which to provide the statement to the person making the request.
13. Review of decisions
Applicants may be entitled to seek a review by the Administrative Appeals Tribunal (AAT) or third party’s may seek a review by a federal court, in relation to an ACPA recommendation, however they should seek independent legal advice on this matter before proceeding.If any affected person is entitled to seek a review of an ACPA recommendation, he/she has 28 days from the date of notification of the recommendation in which to seek a review of the decision.
If the applicant has requested a statement of reasons, then they have 28 days from the date they receive the statement in which to seek a review of the decision.
There are fees associated with seeking a review and anyone requiring further information on this should contact the AAT or Federal Court in their State or Territory.
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