Supply a non-prescription medicine

Information on how to supply a non-prescription medicine.

Non-prescription medicines are comprised of complementary medicines and over-the-counter medicines, including sunscreens.

There are the following types of non-prescription medicines:

listed medicines
assessed listed medicines
registered complementary medicines
over-the-counter (OTC) medicines.

These are categorised on the ingredients they contain and therapeutic indications (claimed health benefits) they use.

Check if your health product is a non-prescription medicine

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Make sure your supplement, vitamin or complementary medicine is regulated as a non-prescription medicine
Understand the non-prescription medicine pathways

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Overview of the application process for the different types of non-prescription medicines.
Non-prescription medicine requirements and standards

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Find out what standards and requirements you must comply with to legally sell or supply your medicine in Australia.
Entering a non-prescription medicine onto the Australian Register of Therapeutic Goods

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Outline of the process for entering your non-prescription medicine onto the Australian Register of Therapeutic Goods.
Managing your non-prescription medicine and TGA account

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Learn about your on-going responsibilities once your non-prescription medicine is on the Australian Register of Therapeutic Goods.
Reforms to the regulation of non-prescription medicines

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Reforms for non-prescription medicines.

Discuss your application with us

If you need further guidance before submitting your non-prescription medicine application, a pre-submission meeting may help address issues you're unclear about.

Read more about pre-submission meetings with TGA.

More information

Sunscreens

Inhalation and nasal sprays

Inhalation and nasal spray registered medicines

Listed and registered medicines

Assessed listed medicines

Over-the-counter medicines

Topics

Latest alerts

Isotretinoin (Roaccutane)

7 April 2025

Safety alerts

Acne medication warnings further highlight potential risks of mood-related changes and sexual disorders.
NAD, NAD+, NADH or NMN medicines sold in Australia

7 April 2025

Safety alerts

We are aware of products being sold in Australia that claim to contain, or influence the levels of, nicotinamide adenine dinucleotide (NAD, NAD+, NADH) or nicotinamide mononucleotide (NMN) in the body.
Counterfeit Ozempic injection pens detected

3 April 2025

Safety alerts

Further examples of counterfeit Ozempic-labelled products have been detected and stopped at the Australian border.

Latest articles

Listed medicines requiring a warning statement

9 April 2025

News

We will be initiating targeted compliance reviews of selected listed medicines that are required to display a warning statement
New safety warnings for isotretinoin (Roaccutane)

7 April 2025

Safety updates

Updates further highlight potential risks of mood-related changes and sexual disorders.
GMP Clearance compliance verification pathway: progress update

4 April 2025

Notices

Update on the progress in reducing the backlog of GMP Clearance Compliance Verification (CV) applications.

Events and webinars

Q&A session in relation to new guidance material ‘Demonstrating the quality of listed probiotic medicines’

30 April 2025

Webinars

This is a Q&A Session for Industry about the recently published guidance on listed probiotic medicines.

Latest publications

Clarification of requirements to access unapproved medicinal cannabis medicines for paediatric patients

3 April 2025

Publications

Clarifies requirements for SAS and AP applications for healthcare practitioners to access Category 2, 3, 4 and/or 5 (i.e. Schedule 8) medicinal cannabis medicines for their patients under the age of 18 years (paediatric patients).
Statement 49 for meeting held 2 October 2024

11 March 2025

Meeting statements

Advisory Committee on Vaccines meeting Statement 49 for meeting held 2 October 2024
Notice of final decision to amend (or not amend) the current Poisons Standard – amygdalin, hydrocyanic acid and Wild Cherry Bark, Joint ACMS ACCS #34

20 February 2025

Scheduling decisions (final)

This web publication constitutes a notice for the purposes of regulations 42ZCZS of the Therapeutic Goods Regulations 1990 (the Regulations).

Resources

Notification of a new proprietary ingredient

26 March 2025

Forms

Updated form used to notify the TGA of proprietary ingredient mixtures for use in therapeutic goods
Applying to use a restricted representation

11 March 2025

User guide

Apply for our approval to use a restricted representation in advertising.
Market action templates

5 March 2025

Forms

Templates to help you with your communications under the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).

Latest consultations

Consultation: Adoption of International Scientific Guidelines in Australia R01-2024

Closed on 16 January 2025

Consultation

We are seeking feedback on whether 19 international scientific guidelines should be adopted.
Consultation: Medicine shortages and discontinuations - Reportable medicines and timeframes for reporting discontinuations

Closed on 13 January 2025

Consultation

We are seeking feedback on proposed improvements to TGA’s regulatory framework for medicine shortages and discontinuations in Australia.
Consultation: 2024-2025 Proposed changes to the Permissible Ingredients Determination – Low-negligible risk

Closed on 13 September 2024

Consultation

The TGA sought feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.

Sub menu

Supply a non-prescription medicine

Check if your health product is a non-prescription medicine

Understand the non-prescription medicine pathways

Non-prescription medicine requirements and standards

Entering a non-prescription medicine onto the Australian Register of Therapeutic Goods

Managing your non-prescription medicine and TGA account

Reforms to the regulation of non-prescription medicines

Discuss your application with us

More information

Sunscreens

Inhalation and nasal sprays

Listed and registered medicines

Assessed listed medicines

Over-the-counter medicines

Latest alerts

Isotretinoin (Roaccutane)

NAD, NAD+, NADH or NMN medicines sold in Australia

Counterfeit Ozempic injection pens detected

Latest articles

Listed medicines requiring a warning statement

New safety warnings for isotretinoin (Roaccutane)

GMP Clearance compliance verification pathway: progress update

Events and webinars

Q&A session in relation to new guidance material ‘Demonstrating the quality of listed probiotic medicines’

Latest publications

Clarification of requirements to access unapproved medicinal cannabis medicines for paediatric patients

Statement 49 for meeting held 2 October 2024

Notice of final decision to amend (or not amend) the current Poisons Standard – amygdalin, hydrocyanic acid and Wild Cherry Bark, Joint ACMS ACCS #34

Resources

Notification of a new proprietary ingredient

Applying to use a restricted representation

Market action templates

Latest consultations

Consultation: Adoption of International Scientific Guidelines in Australia R01-2024

Consultation: Medicine shortages and discontinuations - Reportable medicines and timeframes for reporting discontinuations

Consultation: 2024-2025 Proposed changes to the Permissible Ingredients Determination – Low-negligible risk

Help us improve this page

Site notifications

Supply a non-prescription medicine

Discuss your application with us

More information

Sunscreens

Inhalation and nasal sprays

Listed and registered medicines

Assessed listed medicines

Over-the-counter medicines

Latest alerts

Latest articles

Events and webinars

Latest publications

Resources

Latest consultations

Help us improve this page