Regulatory Applications – Why DIY is a recipe for disaster

Over the years, we have been successful in obtaining a large number of positive recommendations from the Australian Community Pharmacy Authority and the exercise of Ministerial Discretion in relation to requests for section 90 approvals.?

As part of our involvement in applications across the country, we’ve come to know the key submissions and supporting documentation to include in applications to have the best chance of achieving the desired outcome.? Whether or not certain information is included in an application has a significant impact on the outcome of that application.

Given the level of risk (and costs!) involved in regulatory applications, it is imperative to engage the expertise of a professional who is involved in preparing and lodging applications on a regular basis.? You wouldn’t use a general practitioner for knee surgery, or even worse, attempt knee surgery yourself – so don’t do the same in your business.? Place value and importance on your business decisions just as you would your health!

Some of the common errors or issues we see with applications prepared by an inexperienced person include:

• Incomplete documents where key information regarding the proposed premises is missing.? This may be a key date (such as the commencement date of the lease) or key particular (such as the location of an access door on a plan).
• ?Inconsistency of information, particularly key details such as the address of the proposed pharmacy.? It sounds simple but so often the address of the premises is inconsistent between various supporting documents.? This can be fatal to the application as it creates uncertainty regarding the location of the proposed premises and whether the supporting documents all relate to the same premises.
• ?Use of informal documents such as Google Maps for distance measurements.? It is important to use the best evidence possible and whilst Google has its advantages, the distance mapping is not 100% reliable, particularly when needing to measure from specific access points.?
• ?Failing to check information such as calculation of doctors hours, or whether there is a sufficient “joining of the dots” on matters such as legal right to occupy the premises or single management of a medical centre.? Proof reading is important but also important is the need to complete the puzzle of information, particularly when dealing with complex applications such as those under Rule 136 of the Pharmacy Location Rules.
• ?Failing to address the requirements of the Rules.? It goes without saying that if you do not address the requirements set out in the Pharmacy Location Rules and provide sufficient evidence to satisfy those requirements, your application will not be recommended for approval!? Also important to know is that the handbook is a guidance document only.?

Often times, regulatory applications are time sensitive.? Engaging someone who has experience with preparing and lodging applications not only means that your pharmacy business will be up and running in its new location sooner than may otherwise be the case, it also means an investment in getting things right the first time.? Unfortunately, we have seen all too often applicants who either attempt to do an application themselves or use an experienced person investing more than what would have been required had they made an investment in the business upfront (rather than as a correction or crisis measure).

If you have any questions regarding regulatory applications including applications to the Australian Community Pharmacy Authority or requests for exercise of Ministerial Discretion, please contact Vitality Law Australia on (07) 2140 0522 or [email protected]

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Sarah Stoddart is the founder and director of Vitality Law Australia, an award winning commercial law firm servicing pharmacy businesses and healthcare professionals across Australia.? For further information, email [email protected] or visit www.vitalitylawaustralia.com