Overhaul of the PBS approvals process

A short-and-sweet summary of the changes being implemented as early as this December, by Stephanie McGrath

As announced in the budget, the following changes are being implemented as early as this December in respect of applications for approval to supply PBS medicines, as summarised below:

1. Between 11 December 2018 and 1 January 2019 – Transferring administrative functions from the Department of Human Services (DHS) to the Department of Health (Health).

2. From 1 July 2019 – Introduction of an application fee for pharmacists seeking approval to supply PBS medicines (including change of ownership, relocation and establishing new pharmacies).

3. Pharmacists enquiring or applying under Section 90, Section 91, Section 92 or Section 94 will be required to liaise with Health instead of DHS about administrative matters;

4. PBS approval applications and change of detail requests must be lodged via the Health Data Portal using an AUSkey. Applications via email will not be accepted (however DHS will continue to oversee PBS claim payments and manage applications for PBS Online Claiming (PKI certificates) and ABN & Tax Invoice Agreements);

5. Pharmacists’ representatives may still act on behalf of applicant pharmacists submitting an application for PBS pharmacy approval.

First-time users of the Health Data Portal will be required to register with a valid AUSkey. AUSkeys can be obtained from the Australian Business Register website.

To avoid delays, any pharmacists who are likely to be applying for a new PBS approval or to relocate their existing PBS approval in December or later should either:

  • apply for their AusKey and register for the Health Data Portal as soon as possible and before the transition begins on 11 December 2018; or
  • contact the writer to utilise our professional registration and oversee the application on your behalf.

Further information

If you require any specific information or assistance, please do not hesitate to contact the writer on 8628 2039 or stephanie@robertjames.com.au.

Stephanie McGrath is a Senior Associate at Robert James Lawyers practising in commercial law with a focus on health, business and property across Australia.

Disclaimer: The content of this article is intended only to provide a summary and general overview on matters of interest. It is not intended to be comprehensive nor does it constitute legal advice. You should seek legal or other professional advice before acting or relying on any content of this article.

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