Section 19A: Guidance for industry

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Supplying substitute medicines when registered medicines are unavailable or in short supply

6 October 2017

Introduction

This document provides guidance and information to those who wish to supply a substitute medicine in place of a registered medicine that is unavailable or in short supply – including where that medicine is not marketed – where the supply of the substitute medicine is 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, the availability of 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 facilitate the availability of medicines not currently included in the ARTG, in place of a 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.

Follow the Medicine Shortages Information Initiative protocol if you become aware that there may be a current or future issue with the supply of a medicine included in the ARTG, for which you are the sponsor, if the unavailability or short supply of the medicine will have a negative impact on public health.

About section 19A

Section 19A of the Therapeutic Goods Act provides the legislative basis for the Secretary of the Department of Health (the Secretary) to approve the import or supply of a medicine that is not included in the ARTG under either:

  • subsection 19A(1)all ARTG registered goods that could act as a substitute for the goods are unavailable or are in short supply and the goods are from a country specified by the Secretary
  • subsection 19A(1A)all ARTG registered goods that could act as a substitute for the goods are unavailable or are in short supply and the goods are from a country not specified by the Secretary
  • subsection 19A(2) – ARTG registered goods that could act as a substitute for the goods do not exist and the medicine is under evaluation by the TGA to be included in the ARTG.

The Secretary, or their delegate, can grant approval:

  • for a specified period of time

    AND

  • subject to any relevant conditions

    PROVIDED

  • the approval is necessary in the interests of public health.

Before approval can be granted, the applicant must provide evidence that all of the following criteria apply to the medicine by submitting a section 19A application form:

The medicine must be:

  • of the kind included in Schedule 10 to the Therapeutic Goods Regulations 1990 or specified in a determination made by the Secretary under subsection 19A(4) of the Therapeutic Goods Act
  • needed in the interests of public health
  • not able to be substituted with a medicine included in the ARTG because either: OR

    AND either:

  • registered or approved for general marketing in a foreign country – only when it is a substitute for a medicine included on the ARTG that is unavailable or in short supply.

    OR

  • under evaluation for inclusion in the ARTG – when:
    • it is a substitute for a medicine included on the ARTG that is unavailable or in short supply
    OR
    • a substitute does not exist (i.e. when there is an unmet clinical need).

Approval in a foreign country constitutes registration or approval for general marketing in that country. Approval for purposes other than general marketing in the nominated country (e.g. export only use) will not be accepted.

The Therapeutic Goods Administration (TGA) publishes details of section 19A approvals associated with medicine shortages on its website to inform consumers, health professionals and industry. Medicines approved for import and supply under section 19A are subject to the same advertising restrictions and pharmacovigilance activities (such as adverse event reporting and recalls) as those included in the ARTG.

It is an offence to import and supply, or manufacture and supply, medicines that are not included in the ARTG without the prior approval of the Secretary, or subject to an exemption under the Therapeutic Goods Act.

Additional permissions or restrictions may be imposed on the importation of the medicine through the following legislation:

  • Quarantine Act 1908
  • Customs (Prohibited Imports) Regulations 1956
  • relevant state and territory legislation.

Footnote

  1. As defined in Schedule 10 to the Therapeutic Goods Regulations 1990

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