Section 19A: Guidance for industry

Introduction

The TGA has an important role in managing medicine shortages, which includes identifying safe, suitable substitute medicines that ensure patients continued access to important medicines for patients.

This document provides guidance and information to those who wish to supply an overseas medicine in place of a registered, cancelled or suspended medicine that is unavailable, not marketed, or in short supply. Supply of the overseas medicine must be necessary in the interests of public health.

Generally, prescription and over-the-counter medicines^[1] must be included in the Australian Register of Therapeutic Goods (ARTG) before those medicines can be marketed in Australia.

Occasionally, access to a registered medicine is affected by a medicine shortage or unavailability. In these circumstances, there is provision under section 19A of the Therapeutic Goods Act 1989 (the Therapeutic Goods Act) to allow import and supply of medicines not included in the ARTG, in place of a registered medicine or previously registered medicine that is unavailable or in short supply.

Note: This guidance is designed to cover the majority of cases where section 19A approval is granted; that is when there is a medicine shortage. Contact us if you require further assistance to determine if your medicine is eligible for section 19A approval after reviewing the information on eligibility for section 19A approval.

If you are the sponsor of a medicine included on the ARTG and become aware that there may be a current or future issue with the supply, follow the guidance provided at Medicine shortages: Information for sponsors (suppliers)