The operation of pharmacy businesses is highly regulated in Australia on a Federal, State and Territory level. It is therefore critical that you are aware of your legal obligations when opening and operating a pharmacy business.
Whether you wish to relocate your pharmacy, reconfigure the size of your pharmacy or open a new pharmacy, you will require the approvals of both the relevant State’s Pharmacy Council or Board and the Department of Health.
Each Pharmacy Council or Board has their own application forms and different timeframes and procedures apply when it comes to required documentation and inspection of the proposed pharmacy premises.
The main purpose of the relevant Pharmacy Council or Board is to ensure that the new or resized pharmacy premises are compliant with the rules and regulation applicable in the relevant State and Territory.
On top of this, it is the obligation of the relevant Pharmacy Council or Board to ensure that the proposed ownership structure of the pharmacy business is compliant with the Health Practitioner Regulation National Law as applicable in each State and Territory.
The Department of Health, on the other hand, regulates the provision of pharmaceutical benefits from a pharmacy business. This is done on a Federal level and approvals granted by the Department of Health are subject to the Pharmacy Location Rules.
In most cases the Department of Health refers the assessment of applications for the supply of pharmaceutical benefits to the Australian Community Pharmacy Authority (ACPA).
Before the ACPA makes a recommendation to the Department of Health whether or not to approve the pharmacy for the supply of pharmaceutical benefits, the ACPA will review the application itself along with all supporting documents. In the event that some supporting documents are missing or are inconclusive, the application may be rejected or deferred.
What are the Pharmacy Location Rules?
The Pharmacy Location Rules (Rules) are a set of items which set out specific and general requirements that you need to comply with if you seek approval for the supply of pharmaceutical benefits from pharmacy premises.
The items under which an application may be made are as follows:
- Item 121: Expansion or contraction
- Item 122: Relocation within a designated complex
- Item 123: Relocation within the same town (10 km)
- Item 124: Relocation up to 1 km
- Item 125: Relocation of 1 to 1.5 km
- Applications to establish a new pharmacy
- Item 130: New pharmacy (at least 1.5 km)
- Item 131: New pharmacy (at least 10 km)
- Item 132: New additional pharmacy (at least 10 km)
- Item 133: New pharmacy in a small shopping centre
- Item 134: New pharmacy in a large shopping centre with no approved premises
- Item 134A: New additional pharmacy in a large shopping centre with approved premises
- Item 135: New pharmacy in a large private hospital
- Item 136: New pharmacy in a large medical centre
Each of these items have specific requirements you will need to satisfy in order to be granted an approval for the supply of pharmaceutical benefits. These are vastly different for each item and you should seek legal advice in respect of these requirements.
Commonly, there are also specific restrictions imposed by most of the items preventing you from relocating or opening a new pharmacy within close proximity of another pharmacy that already holds an approval for the supply of pharmaceutical benefits.
In addition to the specific requirements and restrictions specified under each item, you must satisfy the following general requirements:
- The proposed pharmacy premises are not approved premises. I.e. there is not already an approval for the supply of pharmaceutical benefits attached to the proposed pharmacy premises.
- You must have the legal right to occupy the proposed pharmacy premises. This means that you must prove either that you own the proposed pharmacy premises or that there is a lease, licence, or agreement in place which allows you to occupy the premises.
- The proposed pharmacy premises could be used for the purpose of operating a pharmacy under applicable local government and State or Territory laws relating to land development. It is therefore important that, before an application is made to the Department of Health, you have obtained a development approval or complying development certificate for the proposed pharmacy premises.
- The proposed pharmacy premises would be accessible by the public. This does not have to be direct street access and can be evidenced by way of photographs of the entrances to the proposed pharmacy business and a clearly-scaled map.
- Within 6 months after the day on which the ACPA makes a recommendation in relation to the application, you must be able to begin operating a pharmacy at the proposed premises.
- The proposed pharmacy premises will not be directly accessible by the public from within a supermarket.
If you are considering establishing a new pharmacy, changing the size of your existing pharmacy or relocating your pharmacy, it is important to consider all relevant rules and regulations that may apply to you.
Failing to properly apply for approvals to the relevant State or Territory Authority and the Department of Health can have severe consequences, including disciplinary action being taken against you if you operate a pharmacy business without all necessary approvals in place.
We advise that you engage professionals to assist you with your applications to ensure that you satisfy the requirements of the Rules and that all necessary supporting documents are in place and submitted with your applications.
The ACPA has strict meeting schedules and failure to provide all required evidence and supporting documentation can result in your application being delayed by several weeks or even months.
Clinch Long Woodbridge has lawyers with excellent experience in all aspects of law relating to pharmacies and we look forward to assisting you.
Please contact our experts, Stephanie Bellman and Peter Clinch for further information.
Important Disclaimer: The content of this publication is general in nature and for reference purposes only. It is current at the date of publication. It does not constitute legal advice and should not be relied upon as such. Legal advice about your specific circumstances should always be obtained before taking any action based on this publication.