Accessing medicines during a medicines shortage

6 October 2017

Prescription and over-the-counter medicines must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be marketed in Australia.

Occasionally, the availability of a registered medicine is affected by a medicine shortage and cannot be replaced by any other medicines included in the ARTG.

In this circumstance, there are provisions to facilitate the availability of unregistered medicines under section 19A of the Therapeutic Goods Act 1989 (the Therapeutic Goods Act). This scheme also enables early access to products undergoing evaluation when no alternative registered goods exist.

When approval can be granted

We can approve the import and supply of a medicine that is not included in the ARTG under section 19A if:

  • registered goods that could act as a substitute for the goods are unavailable or are in short supply

OR

  • registered goods that could act as a substitute for the goods do not exist, but an application has been made for registration of the goods.

We only grant section 19A approvals if it is in the interests of public health. Approvals are subject to relevant conditions and are granted for a specified period of time.

Medicines approved for import and supply under section 19A are subject to the same pharmacovigilance activities (for example, adverse event reporting and recalls) and advertising restrictions as those included in the ARTG.

What we consider

When we consider applications made under section 19A, we minimise risk by considering:

  • clinical need for an uninterrupted supply of the medicine and whether suitable alternatives are available
  • projected demand for the medicine above what current supply can meet
  • appropriate conditions of supply to mitigate risks
  • appropriate duration of supply.

We will not grant approval when risks cannot be appropriately mitigated.

Search approvals

You will be able to search approvals to import and supply medicines that address a medicine shortage. We will include the following details:

  • the medicine approved for import and supply under section 19A
  • name of the approval holder
  • contact details of the approval holder
  • duration of the approval
  • approved indications
  • details of related medicine shortages.

The database of section 19A approvals is currently under development and will be published in late 2017.

Consumers

As a consumer, you may encounter medicines that have been supplied with special permission from the TGA under section 19A of the Therapeutic Goods Act. These medicines will have some features that are different from medicines included in the ARTG. For example:

  • Packaging:
    • the approval holder (the Australian sponsor) applies a sticker containing their name and address or other details of the medicine, such as an English translation of the ingredients
    • information may be communicated in multiple languages.
  • Characteristic of the product:
    • the colouring of the tablet may be different
    • the shape of the tablet may be different
    • the size of the tablet may be different
    • the excipients or formulation of the medicine may be different.
  • Your doctor or pharmacist will advise you on taking the medicine and any changes compared with your usual treatments.

You can use the medicine until it expires, even after the approval under section 19A has ended.

If you have any concerns regarding a medicine that has been prescribed to you, see your doctor or pharmacist.

Health professionals

As a health professional, you may prescribe, supply or administer medicines in relation to which a section 19A approval has been granted.

Section 19A only applies to medicines of the kind covered by Schedule 10 to the Therapeutic Goods Regulations 1990. This covers substances that are included in Schedule 4, 8 or 9 of the Poisons Standard, vaccines, injectable medicine dosage forms and radiopharmaceuticals.

A letter outlining the considerations to be applied for prescribing may accompany the medicine. The following information is usually included, along with any other information specific to the medicine:

  • When the medicine is supplied due to a medicines shortage or unavailability, details on:
    • the registered medicine(s) that the medicine is intended to replace
    • the reason for the short supply of the registered medicine(s)
    • any differences between the registered medicine and the medicine(s) supplied
    • any changes to practice you or your patients may need to make
  • that the medicine has not been approved for general marketing in Australia and is being supplied under section 19A
  • any contraindications for the medicine
  • any potential safety risks
  • how to report adverse events
  • contact details of the Australian sponsor.

If you have any questions or concerns regarding an approval to import and supply a medicine that is not included in the ARTG, contact the sponsor of the medicine or the TGA's Medicine Shortages Section.

Industry

Who can apply to import and supply a medicine under section 19A

Any person can make an application to the TGA to import and supply medicines that are not included in the ARTG in the interests of public health to:

  • address a medicine shortage or unavailability of a registered medicine

OR

  • allow access to a medicine under evaluation for inclusion in the ARTG in the interests of public health.

Note: You do not need to be the sponsor of the medicine that is in short supply to make an application. However, you do need to be in a position to advise the TGA about the availability of that medicine.

If you are the sponsor of medicines that are in short supply, provide information to the Medicines Shortages Information Initiative.

How to apply to import and supply a medicine that is not included in the ARTG

Details on importing and supplying medicines under section 19A are provided in Section 19A: Guidance for industry. This guidance provides information on:

  • introduction to importing and supplying a substitute medicine under section 19A
  • quick reference flowchart of considerations for approval
  • how to apply for approval, including an application form
  • what we do with your application.

For further assistance, contact the TGA's Medicine Shortages Section.