Understand the non-prescription medicine pathways

Non-prescription medicines are entered on the Australian Register of Therapeutic Goods (ARTG) as either listed, assessed listed or registered medicines. This is based on their level of risk to the consumer, determined by the ingredients they contain and their intended use (therapeutic indications).

Unless exempt or excluded, non-prescription medicines must be entered onto the ARTG before they can be legally sold or supplied in Australia.

Listed medicines

Listed medicines have an AUST L number on their medicine label.

AUST L, listed medicines are considered to have a lower risk as they may only use low-risk ingredients and low-level indications that must be selected from pre-approved lists. See: 

• Ingredient requirements for non-prescription medicines
• Indication requirements for non-prescription medicines

Listed medicines are not individually evaluated by the TGA before they are released onto the market; instead, they are automatically included in the ARTG following completion of an application and certification by the sponsor that their product meets all applicable legislative requirements in relation to safety, quality and efficacy. 

See: General guidance for listed medicines for more information

Sunscreens

The majority of sunscreens are regulated as listed medicines. Some can be registered.

See: Australian regulatory guidelines for sunscreens for more information.

Listed medicines do not have application types

Listed medicines, including listed sunscreens do not have application levels, as they do not undergo a TGA pre-market evaluation.

Assessed listed medicines

Assessed listed medicines have an AUST L(A) number on their medicine label.

AUST L(A), assessed listed medicines may only use low-risk ingredients permitted for use in listed medicines. However, they can have at least one intermediate indication (i.e. indications that are above those available for AUST L listed medicines) and may also include lower-level indications. See:

• Ingredient requirements for non-prescription medicines
• Indication requirements for non-prescription medicines

Because they make indications with more risk, assessed listed medicines undergo an efficacy assessment before going on sale. The sponsor must provide high quality evidence to support the medicine such as data from human clinical trials. Assessed listed medicines may display the 'TGA assessed' claim (as a symbol and/or a statement). See: what does TGA Assessed mean on my medicine label?

Assessed listed medicines are entered in the ARTG following self-certification by the applicant of the safety and quality of the product and TGA pre-market assessment of the efficacy evidence supporting the proposed indications. 

See: Assessed listed medicines pathway: frequently asked questions

Assessed listed medicine application types

There are three categories of application for assessed listed medicines, L(A)1 - L(A)3. The increasing levels correspond to the increasing complexity of applications, and consequently, increasing data requirements, evaluation timeframes and fees.

Registered non-prescription medicines

Both registered complementary medicines and over the counter (OTC) medicines have an AUST R number on the medicine’s label.

AUST R registered complementary medicines and OTC medicines are considered to be relatively higher risk than listed and assessed listed medicines, based on the ingredients they contain or the indications made for the medicine. See:

• Ingredient requirements for non-prescription medicines
• Indication requirements for non-prescription medicines

All registered medicines are fully assessed by the TGA for quality, safety and efficacy prior to being available in the Australian market. The sponsor must provide high quality evidence to support the medicine, such as data from human clinical trials. Registered non-prescription medicine evaluations have time frames. See Target evaluation times for OTC medicines 

Registered complementary medicines may apply to use the 'TGA assessed' claim.  See: what does TGA Assessed mean on my medicine label?

Registered complementary medicines application types

Registered complementary medicine applications are categorised according to complexity. There are five levels for applications to register a complementary medicine (RCM 1 to RCM 5).

Each of these levels corresponds to an application category. Applications in lower levels require less supporting information and have lower fees and reduced timeframes compared to applications in higher levels.

See: Applications for registered complementary medicines for more information.

Over the counter medicines application types

Over the counter (OTC) medicine applications are categorised according to risk. There are five risk levels for applications for new medicines (levels N1 to N5) and five risk levels for applications to make changes to existing medicines (levels CN to C4).

Each of these risk levels corresponds to an application category and a route to evaluation or, in the case of CN applications, directly to approval. Applications in lower risk levels require less supporting information than applications in higher risk levels.

See: Australian regulation of over-the-counter medicines for more information.