What is the patient impact of my medicine shortage and do I have to report it to the TGA?

Mandatory reporting requirements apply to all Australian registered prescription medicines (schedule 4 and schedule 8 products), and a limited number of over-the-counter (OTC) medicines (schedule 3) that are listed in the relevant legislative instrument.

View the legislative instrument to see if your OTC product is a reportable medicine.

From 1 January 2019, sponsors are subject to mandatory reporting of medicines shortages affecting the Australian market. These changes will facilitate more proactive, timely and transparent management and communication about medicine shortages and have been established in the interest of Australian public health.

A medicine shortage is defined in the Therapeutic Goods Act 1989 as:

a shortage of a medicine in Australia at a particular time if, at any time in the 6 months after that particular time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine.

A shortage of a reportable medicine must be reported to the TGA within legislated timeframes.

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​Based on your answers, it looks like your circumstances do not meet the definition of a reportable medicine shortage.

Useful links

• Medicine Shortages Information Initiative resources page
• Contact the TGA
• Regulatory affairs consultants ​

Based on your answers, it looks like your product is of medium patient impact.

You are required to report to the TGA a known medicine shortage or anticipated medicine shortage of medium patient impact within 10 working days after you know, or ought to have reasonably known, of the shortage.

This information is required to be reported via the online notification form which can be accessed through the TGA Business Services (TBS) portal. You will need to create an account if you do not already have one.

Useful links

• Medicine Shortages Information Initiative resources page
• TGA Business Services (TBS)
• Contact the TGA
• Regulatory affairs consultants

Based on your answers it looks like your product is of low patient impact.

You are required to report to the TGA a known medicine shortage or anticipated medicine shortage of low patient impact within 10 working days after you know, or ought to have reasonably known, of the shortage.

This information is required to be reported via the online form which can be accessed through the TGA Business Services (TBS) portal. You will need to create an account if you do not already have one.

Useful links

• Medicine Shortages Information Initiative resources page
• TGA Business Services (TBS)
• Contact the TGA
• Regulatory affairs consultants

Based on your answers, it looks like your product is of critical patient impact.

You are required to report to the TGA a known medicine shortage or anticipated medicine shortage of critical patient impact as soon as possible, but no later than 2 working days after you know, or ought to have reasonably known, of the shortage.

This information is required to be reported via the online notification form which can be accessed through TGA Business Services (TBS) portal. You will need to create an account if you do not already have one.

Ideally, you will complete the medicine shortage notification form with all the required information and submit it to the TGA within 2 working days of confirming the shortage. However, an initial report (a medicine shortage notification with reduced mandatory fields) may be submitted within 2 working days containing a subset of the information that is required to be reported to the TGA. You then have a further 3 working days in which to provide the remaining required information on the shortage.

Useful links

• Medicine Shortages Information Initiative resources page
• TGA Business Services (TBS)
• Contact the TGA
• Regulatory affairs consultants

Patient impact of a medicine in shortage is primarily assessed by taking two factors into consideration. The first is the number of people who take the medicine in Australia.

The Medicines Watch List is a legislative instrument setting out a list of known critical medicine ingredients. It helps sponsors and the TGA to simplify and streamline decision-making when determining whether a medicine shortage or discontinuation may have a critical patient impact. Only ingredients from medicines that are included in the Australian Register of Therapeutic Goods (ARTG) are considered for the list.

The list of ingredients included in the Medicines Watch List has been derived from a consensus review of existing state hospital Emergency and Life Saving Drug Lists and the World Health Organization’s Model List of Essential Medicines that are contained in the ARTG.

View the legislative instrument to see if your product is on the Medicines Watch List.

​Patient impact of a medicine in shortage is primarily assessed by taking two factors into consideration. The second factor is the availability of substitute medicines or therapeutic alternatives in Australia.

Substitute medicines or therapeutic alternatives are classified into the following categories:

• EXACT: Same medicine (same active ingredient, strength and route of administration).
• SIMILAR: Same active ingredient but different strength.
• APPROPRIATE: Different active ingredient but same pharmacological class and adverse reaction profiles when administered to patient in therapeutically equivalent doses OR same active ingredient but different dose form that may require consideration of care setting implication.
• POSSIBLE: Different active ingredient but comparable pharmacological class or mode of action.
• NONE: Unique pharmacology (no substitute medicine or alternative treatment options exist).

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​Patient impact of a medicine in shortage is primarily assessed by taking two factors into consideration. The second factor is the availability of substitute medicines or therapeutic alternatives in Australia.

Substitute medicines or therapeutic alternatives are classified into the following categories:

• EXACT: Same medicine (same active ingredient, strength and route of administration).
• SIMILAR: Same active ingredient but different strength.
• APPROPRIATE: Different active ingredient but same pharmacological class and adverse reaction profiles when administered to patient in therapeutically equivalent doses OR same active ingredient but different dose form that may require consideration of care setting implication.
• POSSIBLE: Different active ingredient but comparable pharmacological class or mode of action.
• NONE: Unique pharmacology (no substitute medicine or alternative treatment options exist).

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This material is provided by the TGA (a part of the Department of Health and Aged Care) solely to help sponsors identify if they need to report a medicine shortage. It should not be taken as a detailed description of the scheme or as specific advice on the application of the therapeutic goods legislation in particular cases, nor as a statement of policy.

If you would like further information you should contact the TGA (the TGA website also contains more detailed information on all aspects of the regulatory scheme), or if you need advice on the application of the therapeutic goods legislation in particular cases, you should make your own enquiries to obtain that specific advice.

The Department of Health and Aged Care has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials.