Rule 136 application is in! What happens next?

You’ve lodged your application under Rule 136 of the Pharmacy Location Rules.? What happens next?

Request for further information

Approximately 1 week prior to the meeting date, the Australian Community Pharmacy Authority (“Authority”) will email the applicant, the medical centre and/or the applicant’s solicitor to request further information to demonstrate that the medical centre has continued to operate for at least 70 hours per week and that the doctors are still meeting the required working hours. The best evidence to provide to the Authority in response to the request for information is a further statutory declaration from the medical centre practice manager and a set of updated rosters. The further information must be submitted to the Authority by the due date stated on the email from the Authority. The due date is usually close of business on the day before the meeting of the Authority.

The Authority will notify the applicant or the applicant’s solicitor of the outcome of the application by email in the week following the meeting. ?The outcome is also shown on the PBS Portal. The application will either be deferred, not recommended for approval or recommended for approval. If the application is deferred or not recommended for approval, further correspondence will be provided by the Authority in the week or so following the meeting setting out the reason for the Authority’s decision and, in the event of a deferral, any further information or clarification sought by the Authority.

If the application is deferred...

If the application is deferred, the Authority may offer to reconsider the application “out of session” if further information to address the Authority’s concerns can be provided to the Authority in a timely manner. That means that the applicant does not necessarily need to wait until the next meeting of the Authority to have the application re-considered. The Authority’s willingness to consider an application out of session depends on the nature and extent of the further information or clarification sought by the Authority. It is only when the Authority offers to re-consider the application “out of session” that this option is available to applicants. Otherwise, the application will be re-considered by the Authority at the next scheduled meeting of the Authority.

If the application is not recommended for approval...

If the application is not recommended for approval, the applicant should consider the reasons why the application was not recommended for approval and obtain advice as to whether the reasons are appropriate or whether the decision should be appealed. In some instances, the applicant may decide to appeal the decision and in other instances, the applicant may prefer to address the issue with the application and lodge a fresh application at a later date.

If the application is recommended for approval...

If the application is recommended for approval, the applicant or the applicant’s authorised representative will then need to liaise with the Australian Department of Health and Aged Care regarding the anticipated date for commencement of trade. The Department also needs to be satisfied that the applicant has satisfied the relevant State legislation and, if required, obtained approval from the regulatory body in the relevant State. The Department will not issue an administration number to the applicant until after it is satisfied that the requirements of the relevant State have been met.

When Department is satisfied that the application for supply of PBS medicines from the proposed premises is complete, the administration number will be issued. On the date the applicant intends to commence trade from the premises, the Delegate will make the final decision on whether to issue approval.

The final piece of the puzzle

Before making the final decision, photographs showing that the pharmacy is open and ready to commence trade must be submitted to the Delegate. A delay in providing the photographs will result in a delay in the approval number being activated. It is also important to note that the Delegate can refuse to activate the approval number if it is not satisfied the relevant legislative requirements have been met or if the Delegate is not satisfied that the pharmacy is open and ready to trade.

If you have any queries regarding the Pharmacy Location Rules, please contact?Sarah Stoddart 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