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Section 19A: Guidance for industry

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

4 January 2018

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Processing your application

Timeframe

There is no statutory timeframe for making decisions on applications made under section 19A of the Therapeutic Goods Act. However, we process such applications as quickly as possible, because these requests are made in the interests of public health. Providing accurate and detailed the information will allow the TGA to assess the application and make a decision more efficiently.

If you have any questions regarding your request please contact us.

Assessing applications

We review the available evidence in order to be satisfied that the medicine is suitable for approval under section 19A. We use the flowchart at Summary of considerations for section 19A approval to make an assessment of eligibility for approval under section 19A. This includes a clinical evaluation conducted by medical experts at the TGA.

We also work with you if it is necessary to impose any additional conditions of approval.

Confirming availability of substitutes included in the ARTG

We contact the sponsors of medicines that are unavailable or in short supply, to confirm availability and investigate whether other suppliers of the substitutes are able to increase supply to cover the shortfall.

We can ask sponsors of medicines included in the ARTG for further information on the availability of those medicines under section 31 of the Therapeutic Goods Act.

Approval

If we are satisfied that the criteria for section 19A approval are met, we will approve the importation and supply of the medicine and impose relevant conditions on that approval. We provide you with a notice of approval that outlines the conditions of approval. You must adhere to all conditions listed in the notice.

The period of approval will be specified in the notice of approval. The medicine approved under section 19A must not be imported or supplied after the expiry date or after the approval has lapsed. You must submit a new application if the medicine needs to be supplied in the interests of public health beyond the specified period.

We publish section 19A approvals on our website when they are associated with a medicine shortage.

Rejection

You will be notified in writing if the application is not approved. We do not publish rejections.

Conditions of approval

A number of conditions are likely to be imposed on any section 19A approval. For example, conditions relating to:

  • good manufacturing practice
  • effective communication strategy
  • adverse event reporting
  • reporting on supply.

We may also apply other conditions, depending on the nature of the medicine and the circumstances of approval.

You are not permitted to advertise medicines that are approved under section 19A.

Reporting on supply

Generally, it will be a condition that you provide information about the supply of the medicine approved under section 19A:

  • where the approval is granted for a period of less than six months, reporting will be required on the total amount of product supplied in the period of approval until its expiration or lapsing ('the reporting period')

    OR

  • where the approval is granted for a period of more than six months, reporting will be required on the total amount of product supplied in the first six month period following approval ('the first reporting period') and the amount of product supplied in the period following the first six month period until the expiration or lapsing of the approval ('the second reporting period').

The reports must be submitted within 28 days of the conclusion of each reporting period, and should be emailed to medicine.shortages@tga.gov.au. A report template will be provided with the notice of approval.

Consequences of not complying with conditions

If you do not comply with a condition of a section 19A approval, the Secretary can notify you under subsection 19A(9) of the Therapeutic Goods Act that the approval has lapsed (that is, it has been cancelled). Following any such cancellation, you would be prohibited from supplying or exporting surplus stock.

It is also an offence under subsection 22(7) of the Therapeutic Goods Act to breach a condition of a section 19A approval.

Publication of section 19A approvals

We publish information on section 19A approvals to import and supply medicines on the TGA website when they are associated with the unavailability or short supply of a medicine. Approvals are usually published within five working days after the approval holder has been notified. The following information is included where applicable:

  • details of the medicine covered by the section 19A approval:
    • active ingredient, trade name, strength, dosage form, indications and an image
  • details of the medicine included in the ARTG that is unavailable or in short supply:
    • active ingredient, trade name, strength, dosage form, ARTG number
  • name of the person to whom the approval is granted under section 19A (company name only)
  • period of the approval (expiry date) and information relating to the period of any previous approval granted under section 19A in relation to the medicine (including the reason for its lapsing)
  • additional information relating to supply – such as where there is a delay between section 19A approval and the supply of that medicine
  • related medicine shortage information.

The Medicines Shortage Information Initiative (MSII) also includes a link to the section 19A approvals database.

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