Whether you are currently operating a pharmacy which is experiencing growth, or if you are looking to open a new pharmacy, there are a number of rules and regulations that you will need to consider. The pharmaceutical industry is heavily regulated. As a result, it is critical that you are aware of your legal obligations with operating a pharmacy. These rules are especially important when you are looking to:

  • open a new pharmacy;
  • relocate your current pharmacy; or 
  • resize your existing pharmacy.

This article will explore important factors that you should consider if you currently operate a pharmacy.

Applications For Opening, Relocating or Resizing Your Pharmacy

If you have a pharmacy business or are an approved pharmacist, you still need to apply to the Australian Community Pharmacy Authority (ACPA) to establish a new pharmacy. You will complete this application through ACPA and must accompany it with evidence of your compliance with various rules. If the ACPA is satisfied with your application, you will be able to establish a new pharmacy.

If you are currently operating a pharmacy and wish to relocate it, you must also lodge an application with ACPA. ACPA will then decide whether to grant the approval. When your existing pharmacy is relocated, your existing approval will be cancelled. It will be replaced with a new approval to supply medicines in the new location. When preparing approval for a relocation, you must again provide sufficient evidence that your proposed relocation complies with the pharmacy location rules.

What Are the Pharmacy Location Rules?

Under the pharmacy location rules, there are general requirements that you need to comply with to ensure that your application meets the criteria to be approved. 

The rules are divided into two types, and each apply in different situations. These situations are if you are: 

  1. relocating an existing pharmacy, or
  2. establishing a new pharmacy.

When reviewing your application, the ACPA will assess whether you comply with the rules.

Expanding or Down-Sizing Your Pharmacy

Changing the size of an existing pharmacy falls within the rules for the relocation of an existing pharmacy under the pharmacy location rules. These rules of resizing apply only to pharmacies where the newly sized premises occupy some of the space that the current pharmacy occupies. Otherwise, the proposal may be considered relocation and another rule will need to be referred to. 

To resize your existing pharmacy, you should look to Rule 121 of the rules. This covers rules on the expansion or contraction of a pharmacy.

Relocating an Approved Pharmacy Business

If you wish to relocate your pharmacy, the rules will depend on the nature of the relocation. The pharmacy location rules prescribe different rules based on the type of relocation. It is therefore important to confirm which rule will apply to you. Below is a brief summary of the different types of relocations and the associated rules.

Relocating Within a Designated Complex (Rule 122)

A designated complex includes: 

  • shopping centres;
  • medical centres; or 
  • hospitals.

If you are proposing to relocate your pharmacy within either of these complexes, you will need to provide evidence that the existing premises and the proposed premises do fall within the same designated complex.

Relocation Within the Same Town – 10 Km (Rule 123)

In addition to satisfying the general requirements, if you wish to make an application to relocate your pharmacy within the same town, you must provide a map that demonstrates that the addresses of the proposed and existing premises’ are within the same town. 

Additionally, you must show that the proposed premises are at least 10 km from the nearest approved premises. This must be by the shortest lawful access route that an average person seeking to travel would go.

Relocation Up to 1 Km (Rule 124)

To apply to relocate your pharmacy within a distance of up to 1 km, you must satisfy all the general requirements, and your application must demonstrate that your proposed premises are no more than 1 km, in a straight line, from your existing premises. You also must satisfy that:

  • the existing premises is not in a designated complex; 
  • the existing premises is in a large shopping centre, and the proposed premises are at least 300 m, in a straight line, from all approved premises that are not in that large shopping centre; or
  • the existing premises are in a small shopping centre, a large medical centre or a large private hospital and the proposed premises are at least 500 m, in a straight line, from all approved premises not in those locations.

Relocation of 1 to 1.5 Km (Rule 125)

To relocate your pharmacy 1 to 1.5 km from the existing premises, the rules are similar to those under rule 124. 

The key difference is that, in addition to allowing relocation of between 1-1.5 km, if the existing premises is not in a designated complex, the proposed premises must be at least 300m, in a straight line, from the nearest approved premises.

Key Takeaways

If you are considering establishing a new pharmacy or relocating your pharmacy, it is important to consider any relevant rules and regulations that may apply to you. Pharmacies and pharmaceutical services in Australia have many regulations, so it is important that you are well-aware of these. The pharmacy location rules can assist you in understanding what evidence you will need to apply to make changes to your business. If you have any questions about how to expand, relocate or establish a new pharmacy, contact LegalVision’s business lawyers on 1300 544 755 or fill out the form on this page.

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