About Australian prescription medicine decision summaries (AusPMDSs)

Purpose of AusPMDSs

We publish AusPMDSs to ensure timely, accessible information is available and to support transparency and trust in the TGA’s prescription medicine assessment process.

An AusPMDS is not medical advice and should not be used to prescribe, diagnose, treat, or manage any medical condition. 

Consumers seeking guidance on the safe and effective use of a medicine should consult the Consumer Medicine Information (CMI).

For clinical decision-making, healthcare professionals should refer to the approved Product Information (PI). 

Legal framework for AusPMDSs

The TGA is authorised to publish information about therapeutic goods under section 61 of the Therapeutic Goods Act 1989. This includes the information included in AusPMDSs and Australian public assessment reports (AusPARs).

You can find out what prescription medicines information can be published by the TGA in the following legislation:  

• Therapeutic Goods Information Specification 2017
• Therapeutic Goods (Prescription Medicines – Sharing of AusPARs) (Information) Specification 2023
• Understanding Australian Public Assessment Reports (AusPARs) for prescription medicines.

Section 60 review of an initial decision

If a sponsor disagrees with the TGA’s initial decision, they may ask for a review of their application under Section 60 of the Therapeutic Goods Act 1989. This review process allows a sponsor to seek reconsideration of their application by the Australian Government Minister for Health, Disability and Ageing. For more information on Section 60 reviews refer to requesting the Minister for Health to reconsider the initial decision.

If a sponsor is not satisfied with the Minister’s reconsideration of an initial decision, they may apply to the Administrative Review Tribunal (ART) for a further review of their application.

More information

Consumer Medicine Information (CMI)

The Consumer Medicine Information (CMI) leaflet offers guidance to help consumers use the medicine safely and effectively. It includes information on dosage, how to use the medicine properly, potential side effects, safety precautions, storage instructions, and more.

Product Information (PI)

The Product Information (PI) document provides essential prescribing guidance for health professionals.  It includes details on dosage recommendations, pregnancy category, contraindications, precautions, and potential side effects.

Australian Public Assessment Reports (AusPARs)

AusPARs provide detailed information about the TGA’s assessment of prescription medicine registration applications. They outline the evidence submitted to the TGA and the considerations that informed the decision to approve or not approve the medicine for registration in Australia. 

We aim to publish AusPARs within 3 months of the TGA’s decision to register or not register a prescription medicine in the ARTG.

For more information on AusPARs refer to the About Australian public assessment reports (AusPARs) webpage.

Other resources 

For health advice and information, including a symptom checker and service finder, refer to the healthdirect website.

For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines), call Medicines Line. 

For information on medicines subsidised by the Australian Government, refer to the Pharmaceutical Benefits Scheme (PBS) website.

For data and reports on health and welfare topics in Australia, refer to the Australian Institute of Health and Welfare website. 

Related TGA information

If you think you are experiencing a side effect from a medicine or vaccine, seek advice from a health professional as soon as possible. 

For information on how to report a side effect from a medicine or vaccine, refer to report an adverse event or safety problem.

ARTG entries include the product name and formulation, sponsor and manufacturer details, and links to the Consumer Medicine Information (CMI) and Product Information (PI), where available. Please note that not all CMI and PI documents are published. You can search the ARTG using the medicine name, ARTG identification number, or sponsor name.

For information on prescription medicines and how they are regulated, refer to
prescription medicines.