Vitamins Regulations & Label Numbers in Australia

Vitamins may look like simple everyday products you consume. But they are regulated way more structurally in Australia than many people realise. It is closely regulated, but the vitamin type, its dose, and the claims made about it are what affect it.

So, what does the AUST L, AUST L(A), or AUST R number indicate? How does it affect vitamins? And why are some vitamins assessed before reaching the market while others go under review later? This article explains who regulates vitamins in Australia. Know how they are regulated and the requirements businesses should understand before supplying them.

Regulatory Body for Vitamin Regulations in Australia

The Therapeutic Goods Administration (TGA) is the primary regulatory authority that regulates vitamins in Australia. It is part of the Australian Government Department of Health, Disability and Ageing. They regulate therapeutic goods for safety, quality, and, where applicable, efficacy.

Its regulatory scope recognises vitamins as therapeutic goods. The body has responsibilities that go beyond the product lifecycle and cover vitamin supply regulation, manufacturing, advertising, and post-market compliance.

The Australian Register of Therapeutic Goods (ARTG) is also under TGA. This register has information about the therapeutic goods that can be lawfully supplied in Australia. Applicable requirements are to be followed.

How are Vitamins Regulated in Australia?

TGA follows a risk-based approach to vitamin regulation. Depending on the vitamin type, dose, and other product characteristics, vitamins may be regulated as listed medicines, assessed listed medicines, or registered medicines. Most vitamins fall within the listed medicine category. These products are generally considered lower risk. They are subject to a different level of regulatory scrutiny than registered medicines.

With the regulatory pathway being risk-based, higher-risk medicines have to go through greater pre-market assessment. On the contrary, lower-risk medicines can enter the market through the listed medicine framework, subject to specific requirements.

Understanding Types of Medicines in Australia

Australia has different regulatory pathways that depend on the risk profile and characteristics of a medicine.

1. Listed Medicines

Listed medicines are generally lower-risk medicines. Vitamins are among the products that may fall within this category. Such medicines have the following traits:

• Have an AUST L number
• Can only contain permitted low-risk ingredients
• Can only use permitted low-level indications
• Are generally not individually evaluated by the TGA before being included in the Australian Register of Therapeutic Goods (ARTG)
• Require sponsors to certify that the medicine meets applicable regulatory requirements
• Require sponsors to hold evidence supporting the product’s indications

These medicines must also comply with applicable manufacturing and quality requirements.

2. Assessed Listed Medicines

Assessed listed medicines also contain low-risk ingredients. However, they can make some intermediate-level indications that are not available to standard listed medicines. These medicines have an AUST L(A) number. They use ingredients from the permitted low-risk ingredient framework.

These medicines undergo TGA pre-market assessment and have their therapeutic indications assessed for efficacy. This pathway provides a higher level of pre-market scrutiny than the standard listed medicine pathway.

3. Registered Medicines

Some vitamins may be regulated as registered medicines, including registered complementary medicines. These are generally subject to a higher level of regulatory scrutiny. They may contain higher-risk ingredients or make higher-level therapeutic claims than listed medicines.

Registered complementary medicines have an AUST R number. They are included in the ARTG and undergo pre-market assessment by the TGA for quality, safety and efficacy. Examples may include higher-dose vitamin products or products making claims that require a registered medicine pathway.

Meaning of Label Numbers on Vitamins in Australia

Medicines included in the Australian Register of Therapeutic Goods are assigned an ARTG identification number, commonly displayed with an AUST prefix on the product label.

The AUST number helps identify the regulatory pathway through which the medicine has been included in the ARTG. However, the different numbers also reflect different levels of TGA assessment. For example, an AUST L medicine has not undergone the same pre-market evaluation as an AUST R medicine.

Medicines that don’t have these labels aren’t fit for supply/approved for sale in the market. This covers every such product sold online with unlisted and potentially dangerous ingredients. So, consumers should look for this label before purchasing medicines.

Labeling Requirements for Vitamins in Australia

For medicines included in the ARTG, the relevant AUST number must generally be displayed on the label. Depending on the regulatory category, this may be as follows:

• AUST L – Listed medicine
• AUST L(A) – Assessed listed medicine
• AUST R – Registered medicine

The AUST number identifies the product’s entry in the ARTG and provides information about its regulatory category. Businesses should also ensure that product labelling and therapeutic claims remain consistent with the product’s ARTG entry and applicable regulatory requirements.

Requirements for Vitamins Before Supply in Australia

Vitamin products regulated as listed medicines must meet specific criteria before they can be legally supplied in Australia.

Permitted Ingredients

Listed medicines can only contain ingredients that are permitted under the applicable TGA framework. The ingredients may also have to follow specific conditions or restrictions. So, sponsors should check the requirements that apply to each ingredient before finalising a product formulation.

Permitted Indications

Listed medicines can only use indications from the TGA’s list of permitted indications and must comply with any requirements attached to those indications. These indications are for lower-risk therapeutic uses. These medicines cannot make claims that are outside the permitted framework.

Evidence Supporting Indications

The TGA does not generally evaluate the evidence supporting the indications of standard listed medicines before they enter the market. However, sponsors must certify that they hold appropriate evidence supporting the indications and claims made about their medicine. The authorities may request this information during a compliance review.

Manufacturing Requirements

Medicines must be manufactured in accordance with applicable manufacturing quality requirements. The TGA’s vitamin regulation framework also requires listed medicines to be manufactured under appropriate quality manufacturing principles.

Process of Adding Vitamin Products to ARTG

In Australia, vitamins that are regulated as therapeutic goods need to be included in the Australian Register of Therapeutic Goods (ARTG) before supply. A specific exemption or alternative pathway is an exception. The appropriate ARTG pathway depends on factors such as the following:

• Ingredients used
• Therapeutic indications proposed
• Risk profile of the product
• Level of evidence required
• Applicable regulatory requirements

For listed medicines, the sponsor applies for inclusion through the TGA’s listing process and certifies that the product meets the relevant requirements. The exact regulatory process depends on the classification of the vitamin product.

The following steps outline the general pathway for vitamins that qualify as standard listed medicines (AUST L), which are generally lower-risk products.

Step 1: Decide the Correct Regulatory Pathway

Start by knowing how your vitamin product will be regulated. It depends on factors like the product’s ingredients, dosage, and proposed therapeutic indications. On this basis, it may follow the listed, assessed listed, or registered medicine pathway. Most lower-risk vitamin products that meet the listed medicine requirements may follow the AUST L pathway.

Step 2: Check Ingredient Eligibility

For a listed medicine, the ingredients must be permitted for use under the applicable TGA framework. Sponsors should also check whether any conditions or restrictions apply to the ingredients, including their permitted purpose or use. If an ingredient is not permitted for use in listed medicines, the standard listed medicine pathway may not be appropriate.

Step 3: Select Appropriate Therapeutic Indications

Listed medicines can only make permitted low-level indications. The proposed indications must comply with the applicable requirements and be appropriate for the product. Sponsors must also hold evidence supporting the therapeutic indications made for the vitamin product.

Step 4: Confirm Manufacturing and GMP Compliance

The product must be manufactured in accordance with applicable Good Manufacturing Practice (GMP) requirements. For Australian manufacturers, the relevant manufacturing licence requirements apply. Where manufacturing takes place overseas, the Australian sponsor may need to hold the appropriate TGA GMP clearance for the manufacturing site and relevant manufacturing steps.

Step 5: Prepare the Product Information and Supporting Evidence

Before submitting an application, the sponsor should ensure that key product information and supporting documentation are established. This includes the following, where applicable:

• Product formulation
• Ingredient information
• Manufacturing arrangements
• Product specifications
• Shelf-life information
• Proposed indications
• Evidence supporting the indications

The TGA states that sponsors should have the necessary information and evidence available before submitting an application rather than planning to obtain it after listing.

Step 6: Apply Through TGA Business Services

Applications for listed and assessed listed medicines are submitted electronically through TGA Business Services (TBS). For a standard listed medicine, the sponsor submits the required product information and certifies that the medicine meets the applicable legislative requirements.

Step 7: Inclusion in the ARTG

If a standard listed medicine application is accepted and the product is entered in the Australian Register of Therapeutic Goods (ARTG), it receives an AUST L number. The product can then be legally supplied in Australia, subject to ongoing compliance with applicable requirements.

Step 8: Maintain Post-Market Compliance

Regulatory obligations continue after the product enters the market. The sponsor remains responsible for ensuring that the vitamin continues to comply with applicable requirements. The TGA may conduct post-market compliance reviews and may request supporting information, including evidence supporting therapeutic indications.

Documents & Information Required for Listing a Vitamin in Australia

For a standard listed vitamin medicine, the TGA does not necessarily require all supporting evidence to be submitted as a traditional pre-market product dossier. Instead, the sponsor must hold the required information and evidence and certify compliance with applicable requirements. However, different documentation and pre-market evidence requirements apply to assessed listed medicines and registered medicines.

For a standard listed medicine, key information and documentation may include:

1. Product Formulation and Ingredient Information

The sponsor should have complete information about the vitamin product’s formulation, including its ingredients and relevant product specifications. For listed medicines, ingredients must be permitted for use under the applicable TGA framework and comply with any conditions attached to their use.

2. Product Specifications

Sponsors should have documented specifications demonstrating that the medicine meets applicable quality requirements throughout its shelf life. This includes information relevant to product quality, shelf life, storage conditions, expiry date, and applicable specifications.

These critical elements, such as the formulation, specifications, and shelf life, should be appropriately established and documented before submitting an application.

3. Manufacturing Details

The application requires accurate information about the manufacturers involved in the production of medicine and the manufacturing steps for which they are responsible. For listed medicines, relevant manufacturing steps can include the following:

• Manufacture of the dosage form
• Packaging and labelling
• Release for supply
• Microbial testing
• Chemical and physical testing

The sponsor is responsible for ensuring that the ARTG entry contains the relevant and current manufacturer information.

4. GMP Evidence

Evidence of Good Manufacturing Practice (GMP) compliance is required for applicable manufacturing arrangements. Depending on where the product is manufactured, this may include a TGA GMP licence for an Australian manufacturer, where applicable, and a TGA GMP clearance for an overseas manufacturing site

For imported vitamins regulated as listed medicines, the Australian sponsor must hold the appropriate GMP clearance for relevant overseas manufacturing sites.

5. Evidence Supporting Therapeutic Indications

Sponsors must hold evidence supporting the therapeutic indications made for a listed medicine. The evidence should be available when the medicine is listed and must continue to be held while the medicine remains in the ARTG. The TGA may request this evidence during a post-market compliance review.

6. Proposed Product Label Information

The sponsor should have the product’s labelling information established and ensure that it complies with applicable regulatory requirements. The label and therapeutic indications should be consistent with the product’s ARTG entry and regulatory category.

7. Sponsor Certifications and Application Information

A standard listed medicine is entered into the ARTG based on information submitted by the sponsor and the sponsor’s certifications that the medicine meets applicable legislative requirements. Applications are submitted through the TGA Business Services portal. Sponsors should ensure that all critical information and supporting evidence are available before submitting the application.

Conclusion

Australia regulates vitamins through a risk-based therapeutic goods framework. Depending on their characteristics, vitamins may be listed medicines, assessed listed medicines or registered medicines. The AUST number on a product label provides a useful indication of its regulatory category and the level of assessment associated with that pathway.

For businesses, understanding the correct classification early is essential. Ingredients, dosage, and therapeutic indications can all affect the regulatory pathway and the requirements that apply before a vitamin can be supplied in Australia.

Artixio can support businesses with regulatory pathway assessment, ingredient and indication review, ARTG-related requirements, and regulatory support for nutrition products in Australia. Connect with us at info@artixio.com.

FAQs

Does TGA regulate all vitamins in Australia?

Yes. The TGA regulates all vitamins in Australia for safety and quality. Depending on the type and dose of the vitamin, the product may be regulated as a listed, assessed listed or registered medicine.

What does AUST L mean on a vitamin label?

AUST L identifies a listed medicine included in the Australian Register of Therapeutic Goods. Listed medicines are generally lower-risk medicines and are not individually assessed for efficacy by the TGA before supply. Sponsors must nevertheless meet applicable requirements and hold evidence supporting their indications.

Can listed vitamin products make any health claim?

No. Listed medicines must use indications from the TGA’s permitted indications framework and comply with the requirements applicable to those indications. Sponsors must also hold appropriate evidence to support the claims made about their products.

Is the TGA responsible for monitoring vitamins after they enter the market?

Yes. The TGA takes care of post-market surveillance and compliance reviews. Listed medicines may be reviewed to assess compliance with regulatory requirements, including evidence supporting indications and product claims. Non-compliant products may be subject to regulatory action, including cancellation from the ARTG.