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Medicine shortages/discontinuations - Electronic notification form: User guide

21 December 2018

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Introduction

This document provides guidance to external users, including medicine sponsors, for the medicine shortages – electronic notification form (notification form). It outlines how to submit shortage/discontinuation notifications to the Therapeutic Goods Administration (TGA) through TGA eBusiness Services (TBS), taking into consideration the implementation of mandatory reporting of shortages of all reportable medicines from 1 January 2019.

This guide is one of a number of resources developed and delivered under the Medicine Shortages Information Initiative (MSII) to improve the communication and management of medicine shortage events. This work is a joint initiative of the Medicines Partnership of Australia (comprising the National Pharmaceutical Services Association, Generic and Biosimilar Medicines Association, Pharmacy Guild, Pharmaceutical Society of Australia, Australian Self Medication Industry and Medicines Australia), the Australian Government Department of Health (including the TGA), the Society of Hospital Pharmacists of Australia and the Australian Medical Association.

Who should use this guide?

This document is a reference guide for sponsors of current reportable medicines as defined in the Therapeutic Goods Act 1989.

Reportable medicines are defined in the legislation as:

(1) For the purposes of this Act, registered goods are a reportable medicine if:

(a) the goods are medicine; and

(b) either:

(i) the medicine contains one or more substances included in Schedule 4 or 8 to the current Poisons Standard; or

(ii) the medicine is determined in an instrument under subsection (2).

(2) The Minister may, by legislative instrument, determine medicine for the purposes of subparagraph (1)(b)(ii).

That is, all prescription medicines that are entered on the Australian Register of Therapeutic Goods (ARTG) and a small number of non-prescription medicines set out in the Reportable Medicines List. The criteria for inclusion of a non-prescription medicine are:

  • the medicine is critical to the ongoing health of the patient (for example, salbutamol asthma inhalers)
  • inclusion of the medicines is critical for public health (for example, naloxone injections for opioid overdose).

How to use this guide

This guide has been written for users when completing the Medicine shortages – electronic notification form on TBS. This document is written in a task-based manner, with step by step instructions and examples as required.

Assumptions

It is assumed that users are familiar with mouse skills, have a TBS login and have a basic knowledge of the TBS environment. If you require a TBS login, please see Help.

Legislative basis

The Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 passed through both houses of the Australian Parliament and received Royal Assent on 21 September 2018.

From 1 January 2019, the Therapeutic Goods Act 1989 requires the mandatory reporting of shortages (including discontinuations) of reportable medicines.

Medicine shortages and discontinuations of medicines deemed to be of critical patient impact will be mandatorily published on the MSII landing page on the TGA website.

Medicines shortages or discontinuations of medicines deemed to have a medium or low patient impact are also subject to mandatory reporting, but are not subject to mandatory publication.

Help

If you have any questions relating to the notification form or on medicine shortages, please contact the TGA's Medicine Shortages Section on:

The TGA TBS Help Desk operates Monday to Friday from 8:30am to 5:00pm AEST, excluding public holidays.

If you have any questions relating to acquiring a TBS login or accessing the TGA TBS site, please contact the Help Desk on:

Medicine shortages – electronic notification form

Overview

A medicine shortages notification form is available from the TGA TBS website. Sponsors can log into TBS and select their own ARTG entries that are or will be involved in a medicine shortage or a discontinuation.

Details of the shortage or discontinuation can be entered and submitted to the TGA electronically.

Benefits

  • The notification form uses the same functionality as other TBS applications including saving partially completed forms and an ongoing record of the status, updates and communications.
  • If upon submission the TGA requires further information to assess the shortage the notification form can be returned to the sponsor (via push back) and changes and additions can be made and re-submitted.
  • Each notification form is owned and controlled by the sponsor; information relating to the product or sponsor activities contained within it cannot be changed or added to by the TGA.
  • Early notification of critical patient impact shortages in the absence of full information is still viable as the notification form allows the notification to be validated with reduced mandatory fields for shortages of critical patient impact and subsequently updated.
  • Information from one notification form can be copied into another when there is the need to submit multiple ARTG entries at a time, for example for different dosage forms or strengths.
  • There is provision for users to attach information such as 'Letters to Prescribers' and/or references to specific web links to support the communication activities.

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