About section 19A

This provision is particularly important in the management of medicine shortages. 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. Import and supply is approved in place of an Australian substitute medicine that is either

• registered on the ARTG and unavailable or in short supply, or
• not yet registered on the ARTG, but the subject of a section 23 application to register the medicine that has passed preliminary assessment, or
• previously registered and no longer available (for example the medicine was discontinued from the Australian market).

Import or supply in place of a registered medicine can occur under either:

• subsection 19A(1) - 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) - 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.
• subsection 19A(2A) - goods which were previously registered on the ARTG and are cancelled or suspended could act as a substitute, and the goods are from a country specified by the Secretary.
• subsection 19A(2B) - goods which were previously registered on the ARTG and are cancelled or suspended could act as a substitute, and the goods are from a country not specified by the Secretary.

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:
  • suitable substitutes are unavailable or in short supply
    OR
  • there are no suitable substitutes presently included in the ARTG.
    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.