Section 19A: Guidance for industry

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

Book pagination

6 October 2017

Eligibility for section 19A approval

The unavailability or short supply of a particular medicine included in the ARTG will ordinarily not have a significant impact on public health where there are other medicines available on the market that may be supplied in its place. Other medicines included in the ARTG that may be suitable substitutes include those medicines that are:

  • the same in all relevant respects to the medicine that is unavailable or in short supply, but available from another manufacturer or supplier

    OR

  • closely related to the medicine that is unavailable or in short supply and may be used safely in its place.

However, if there are no suitable substitutes included in the ARTG, or all suitable substitutes are also unavailable or in short supply, the unavailability or short supply of the registered medicine may have a negative impact on public health.

In these circumstances, the Secretary or their delegate can grant approval to import and supply a substitute medicine that is not included in the ARTG in place of the medicine that is unavailable or in short supply under section 19A of the Therapeutic Goods Act. Generally, only one section 19A approval is granted for each shortage, go to When TGA receives multiple applications for more information.

The following sections provide a general guide to determine if a medicine is eligible for such approval. These considerations are also summarised in a flowchart at the end of this section.

Products must be medicines

Section 19A only applies to medicines, of the kind included in Schedule 10 to the Therapeutic Goods Regulations 1990, or where the goods have been specified in a determination made by the Secretary under subsection 19A(4).

Note: To date, the Secretary has not made any determinations under subsection 19A(4) to allow products, other than those included in Schedule 10 to the Therapeutic Goods Regulations 1990, to be supplied under section 19A.

Supply must be in the interests of public health

The Secretary, or their delegate, uses the information provided at Justification that approval is necessary in the interests of public health, and any other relevant information, to determine whether approval of an application is in the interests of public health. Generally, the following matters will be considered:

  • the availability of other treatments for the disease or condition
  • whether other available treatments meet the therapeutic requirements of the patient population
  • the suitability of substitutes for the intended patient population
  • the consequences of discontinued treatment or changing treatment
  • any additional health risks associated with the medicine that is the subject of the application
  • the projected demand for the product above that which the current supply can meet.

Suitable substitutes

As part of a section 19A application, the applicant should consider whether there are suitable substitutes already included in the ARTG.

The applicant should identify and assess the suitability of all potential substitutes included in the ARTG that are exact, similar, appropriate or possible, as defined in the Medicines Shortages Information Initiative protocol, which includes the medicine that is unavailable or in short supply.

Suitable substitutes may also include goods that are therapeutic devices. However, this is relatively unlikely in practice. For convenience, this guidance predominantly references substitute medicines.

In some cases, suitable substitute medicines may be included in the ARTG, but at the time of the application, are unavailable or in short supply.

For an application to be approved, all potential substitutes must be found to be unsuitable to meet the public health need, or all suitable substitutes must be unavailable or in short supply.

Applicants should identify all potential substitutes whether or not those substitutes are available at the time an application is made under section 19A. Any approval granted under section 19A will lapse if a suitable substitute becomes available during the course of the approval – go to Lapsing of approvals for more information.

Determining suitability

To determine suitability, the Secretary, or their delegate, will consider:

  • how close the substitute is to the medicine for which section 19A approval is being sought, including the approved indications
  • how feasible it is to use the substitute in the context of the patient population and the associated care setting
  • how appropriate it is to use the substitute in the intended patient population, including consideration of contraindications
  • how appropriate the dosage form of the substitute is in treating the proposed indications of the medicine for which section 19A approval is being sought.

Further consideration of potential substitutes

Sometimes, patients may be on a medicine included in the ARTG that is about to become unavailable or in short supply. In such circumstances, the transition from one medicine to another is an important consideration. The transition to the medicine for which section 19A approval is being sought should be compared with the transition to any potential substitute, having consideration to the following matters:

  • changeover requirements for patients, such as wash-out, weaning or lag time prior to commencement of the new medicine and the clinical effect
  • whether one medicine provides a more stabilised course of treatment
  • whether the medicine for which section 19A approval is being sought may be in the interests of patient care and safety even though there is a potential substitute included in the ARTG.

Early access to medicines under evaluation

If there is no medicine presently included in the ARTG for the treatment of a specific indication, approval can be granted under subsection 19A(2) of the Therapeutic Goods Act to allow early access to a medicine that is currently under evaluation for inclusion in the ARTG.

The Secretary, or their delegate, must be satisfied that:

  • there are no registered goods that would be a suitable substitute for the medicine

    AND

  • an application for inclusion in the ARTG (under section 23 of the Therapeutic Goods Act) has been made to the TGA.

Note: For early access to a medicine that is under evaluation, section 19A(2) approval lapses when a decision has been made on the relevant section 23 application. If the medicine remains unavailable or in short supply for a period following the registration of the medicine, a new application must be approved under subsection 19A(1) of the Therapeutic Goods Act to continue the import and supply of a substitute medicine. Go to Lapsing of approvals for more information on requesting a new approval to change from subsection 19A(2) to 19A(1) following the inclusion of a medicine in the ARTG.

Specified foreign countries

If the medicine for which section 19A approval is being sought is not under evaluation for inclusion in the ARTG, it may be registered or approved for general marketing in a country specified by the Secretary in a written determination under subsection 19A(3) of the Therapeutic Goods Act.

The current specified countries are:

  • Canada
  • France
  • Germany
  • Netherlands
  • New Zealand
  • Sweden
  • Switzerland
  • United Kingdom
  • United States of America.

Prior to submitting an application, applicants should check the Therapeutic goods determinations web page for any changes.

When the country is not specified

In rare cases, the only medicines that are available globally to address a shortage are not available in any of the countries that the Secretary has specified. The Secretary or their delegate may grant section 19A approval in this circumstance if the following criteria are met:

  • the medicines that are needed are not registered or approved for general marketing in any of the countries specified by the Secretary in a legislative instrument under subsection 19A(3), or if they are approved in such a country, they are not readily available for importing into Australia, but are registered or approved for general marketing in another country

    AND

  • the manufacturing and quality control procedures used in the production of the medicines are acceptable

    AND

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

The decision to grant approval under section 19A(1A) is complex and the Secretary will make a decision balancing:

  • the robustness of the regulatory system in place in the foreign country in which registration or approval for general marketing of the specific therapeutic good proposed for supply under section 19A has been granted

    AND

  • the history of regulation and manufacture of the particular medicine

    AND

  • justification that the medicine is needed in the interests of public health.

The outcome may differ depending on the strength of each consideration. A shortage that potentially poses a very high level of risk to public health (in the sense that patients are likely to die if they are not able to access the medicine for the period of the likely shortage) may require the Secretary to consider section 19A approval to allow the supply and/or import of a particular medicine from a specific country even if the relevant regulatory system is not as robust as Australia or the medicine does not have a long history of safe use in that market.

If the shortage does not potentially pose such a significant risk to public health then the Secretary may consider that the potential benefit to public health from the medicine would be outweighed by the potential risk of approving the import and supply of a medicine from a country whose regulatory system is not as robust as Australia or without a long history of safe use of that medicine.

The following illustration demonstrates the consideration between the balance of potential risk and level of confidence.

Low to High: Potential risk to public health posed by the medicine shortage
High to Low: Level of confidence in the robustness of regulatory system and teh specific product to be supplied under section 19A

Summary of considerations for section 19A approval

The following flowchart summarises the considerations for section 19A approval to import and supply medicines that are not included in the ARTG.

see Text version below
  1. Is the medicine of the kind included in Schedule 10 to the Regulations?
    1. YES: Go to Step 2.
    2. NO: Not eligible for section 19A approval – end flowchart.
  2. Is the medicine necessary in the interests of public health?
    1. YES: Go to Step 3.
    2. NO: Not eligible for section 19A approval – end flowchart.
  3. Are there suitable substitutes included in the ARTG?
    1. YES: Go to Step 4.
    2. NO: Go to Step 7 – Application is for early access to a medicine under evaluation.
  4. Are all the suitable substitutes included in the ARTG unavailable or in short supply?
    1. YES: Go to Step 5.
    2. NO: Not eligible for section 19A approval – end flowchart.
  5. Is the medicine registered or approved for general marketing in a specified foreign country*?

    OR

    Is there a current application under section 23 for the inclusion of the medicine in the ARTG?
    1. YES: Eligible to apply for section 19A(1) approval – end flowchart.
    2. NO: Go to Step 6.
  6. Is the medicine registered or approved for general marketing in a foreign country (not specified*)?

    AND

    Are the manufacturing and quality control procedures acceptable?
    1. YES: Eligible to apply for section 19A(1A) approval – end flowchart.
    2. NO: Not eligible for section 19A approval – end flowchart.
  7. Is there a current application under section 23 for the inclusion of the medicine in the ARTG?
    1. YES: Eligible to apply for section 19A(2) approval– end flowchart.
    2. NO: Not eligible for section 19A approval – end flowchart.

*Specified foreign countries: Canada, France, Germany, Netherlands, New Zealand, Sweden, Switzerland, United Kingdom, United States of America.

Book pagination