4. Labeling Requirements

Food Supplements
Australia

This section provides information on labeling requirements and the label approval process.

4.1 Mandatory Labeling Parameters

Complementary Medicine products must be labeled in compliance with TGO 92 [1] which covers Listed Medicines (AUST L and AUST L(A)) and Registered Complementary Medicines (AUST R). There is a combined guidance document [2] that describes the requirements of TGO 92 and TGO 91 (the prescription medicine standard - link not provided as this is not relevant to Complementary Medicines).

Since medicines are not covered under the Food regime in Australia, nutritional information panels are not required, this is to ensure that these medicines are not mistaken by consumers as foods. There are a number of terms referring to different labels and panels within single labels and definitions of these are provided in the Additional Notes section below (section 4.7). 

In general, the following lists the mandatory labeling parameters for Complementary Medicines:

- product name or name of the medicine

- directions for use, including any preparation details if the medicine requires dissolving, reconstitution, etc.,

- at least one statement of purpose (indication)

- AUST R, AUST L(A) and AUST L numbers

- batch number and expiry date

- the name of the dosage form

- quantity of the medicine in the pack

- name and contact details of the sponsor (or nominated distributor)

- ingredient list (all active ingredients and their quantity) 

- statements in relation to allergens (including the presence of certain excipients and impurities)

- warning statement (if applicable)

- storage conditions

- any relevant wording concerning tamper evidence features.

Main Points 

Unless exempt, medicines are required to be labeled. Exemptions are listed in Section 5 of TGO 92 [1].

Labels are considered to be advertisements (Chapter 1.1.2 of Ref [2]) and therefore must comply with the advertising requirements for medicines (please refer to section "5. Claim requirements"). All information required to appear on labels must remain legible for the shelf life of the product and labels should be firmly affixed. Artwork choices such as background color and font color should ensure that information is clear and legible.

Most requirements are the same for AUST L, AUST L(A), and AUST (R) Complementary Medicines. The differences are outlined below.

The container, intermediate packaging (if any), and primary pack in which a medicine is packed must each bear a label or labels that comply with the requirements of TGO 92 that are applicable in relation to that medicine - Clause 7(1) of [1]. Clause 7 of [1] outlines the general requirements for labels. Clause 8 outlines the information that is to be included on labels and Clause 9 outlines the information required on each main label, although there are exemptions permitted (Clause 10) for small containers, strip and blister packs, and some other items.

There are differing requirements for text size for the labels, depending upon the listing/registration status. These are described in various sections of Ref [1]. It is recommended to refer to Chapter 1.4.1 of Ref [2] for a clearer description and examples of the requirements, including how the height of the text is calculated.

4.2 Languages

English.

Languages other than English may be included on product labels, provided the information is true and correct, does not breach the provisions of the therapeutic goods legislative requirements, and does not obscure the readability of the required information. It is also permissible to include braille on labels, although this has little or no uptake in the marketplace for this category of products.

4.3 Mandatory Information on Stickers

Stickers are generally not permitted, except in exceptional cases such as when there is a new advisory statement and the product is already packaged (commercial reasons) or for the marketing authorization number as described above. If the mandatory labeling information cannot fit on either the label of the primary pack or the container, then there are provisions to use a package insert for some information (Clause 8) or to not repeat all mandatory items on some main labels (Clause 10) for example blister packs, small containers [1].

4.4 Product Legal Name

The name of the medicine is as it appears on the Certificate of Listing (for AUST L and AUST L(A) medicines) or the Certificate of Registration (AUST R medicines) - Clause 6 of [1]. The name of the medicine on the main label must be presented in a continuous, uninterrupted manner and not be broken up by additional information or background text - Clause 9(2) of [1].

4.5 Product-specific Labeling Statements

AUST L/L(A)/R number (Marketing Authorization number): TGO 92 [1] does not refer to these in the context of the product labels. However, the MA number is required on labels under Regulation 15 [3]. Since the AUST L/L(A)/R number is not mentioned in ref [1], they can be:

(1) oriented in any direction on the label, and 

(2) displayed in a text size that is smaller than the minimum text size otherwise required by the Orders. 

Regulation 15 [3] requires the MA number on the main label (refer to the regulation for specifics with different packaging configurations) with a font size of not less than 1 millimeter in height. This can be added to a sticker.

Listed Complementary Medicines (AUST L)

These medicines should have the AUST L number displayed on the label as described above. This category of medicine must not have any reference to TGA approval (e.g., 'TGA approved' or 'Assessed by the TGA"), since they do not undergo a full pre-market assessment. There are some examples of unacceptable presentations included in the guideline [4]. 

Listed Assessed Complementary Medicines (AUST L(A))

Essentially the requirements are the same as for AUST (L) medicines, with the AUST L(A) number on the main panel instead of an AUST L. However, sponsors are able to use a 'claimer' on product labels to indicate that the efficacy of the product has been assessed. This can take the form of an approved symbol and the text: 'Evidence for the approved indications has been assessed by the TGA'. Ref [5] provides information on these.

Registered Complementary Medicines (AUST R)

Registered Complementary Medicines must bear the AUST R number on labels on the main panel, in a manner as described in the other two categories of Complementary medicines. Unless exempt (refer to clause 8(3) of [1] for exemptions), labels for Registered Complementary Medicines must have some mandatory information presented with headings in the Critical Health Information (CHI) format. The requirements are outlined in Clause 8(2)(b) of [1] and examples are provided in Section 4 [2].

4.6 Authority Approval

Listed Complementary Medicines (AUST L)

Labels for AUST L medicines (Listed Complementary Medicines) do not need to be approved by the authority. These are not assessed as part of the application.

Listed Assessed Complementary Medicines (AUST L(A))

Labels for AUST L(A) medicines are assessed as part of the pre-market screening for efficacy information. The TGA is the approving authority. The cost and duration are built into the marketing authorization process (see section "6. Registration processes).

Registered Complementary Medicines (AUST R)

Labels for AUST R medicines are assessed as part of the pre-market screening for quality, safety, and efficacy. The TGA is the approving authority. The cost and duration are built into the marketing authorization process (see section "6. Registration processes).

4.7 Additional Notes on Labeling

Definitions relevant to labeling

(a) container, in relation to therapeutic goods, means the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover, or other similar article that immediately covers the goods, but does not include an article intended for ingestion. [6] 

(b) intermediate packaging means a level of packaging that, if it exists, encloses one or more containers and is itself enclosed in a primary pack. [1]

(c) primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers. [6]

(d) the main label means [1]: 

1. where there are two or more labels or two or more portions of a single label -that label or portion of the label where the name of the medicine is more or most conspicuously shown; or 
2. where the name of the medicine is equally conspicuous on two or more labels or portions of a label – each label or portion. 

Tamper evidence packaging

There is a voluntary code of practice for tamper-evident packaging [7] which is followed by many sponsors due to it being a requirement for membership in industry associations. The impact of historical tampering of a popular paracetamol brand in the year 2000 [8] led to many sponsors adopting tamper evidence measures, particularly for General Sales products. If sponsors use such tamper evidence features, labeling must carry the relevant wording described on page 13 of the guideline [2].

Data matrix codes on labels

TGO 106 guide [9] describes the requirements for serialization and data matrix codes on medicine packaging. This order applies only to products where the sponsor has been an early adopter of such codes or of serialization. Its use is not mandatory. A data matrix code is a type of two-dimensional code that can be read by a 2D scanner. It is a small square or rectangle with two solid edges, two dotted edges, and pixelated light and dark areas within the matrix. There are no fixed shapes within the matrix. This is not the same as a conventional barcode or QR code. Should a sponsor use serialization or data matrix codes for their products, they should comply with this order. [10]

Required Advisory Statements (RASML)

TGO 92 [1] requires some products to contain warning statements (advisory statements) about specific risks related to the use of medicines. These are listed in the RASML guidance. [11]

4.8 References

1. Therapeutic Goods Order No 92 - Standard for labels for non-prescription medicines

https://www.legislation.gov.au/Details/F2017C00744/Download

2. Medicine labels guidance on TGO 91 and TGO 92; Version 2.3, March 2021 (PDF)

3. Therapeutic Goods Regulations 1990

https://www.legislation.gov.au/Details/F2023C00011/Download

4. Listed medicine presentation and labels. Australian regulatory guidance. Version 1.1, September 2020. (PDF provided)

5. TGA assessed claim for assessed listed and registered complementary medicines

https://www.tga.gov.au/resources/publication/publications/tga-assessed-claim-assessed-listed-and-registered-complementary-medicines

6. Therapeutic Goods Act 1983

https://www.legislation.gov.au/Details/C2021C00376/Download

7. Code of practice for tamper-evident packaging of therapeutic goods, version 2.0, May 2017 (PDF provided)

8. ACCC information on the Heron Paracetamol recall in 2000

https://www.productsafety.gov.au/recalls/herron%E2%80%94paracetamol-tablets-capsules

9. Standard for serialization and data matrix codes on medicines. Guidance for TGO 106. Version 1.0, March 2021 (PDF provided)

10. Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021  

https://www.legislation.gov.au/Details/F2021L00333/Download

11. Required advisory statements for medicine labels (RASML). The webpage includes links to the document and also guidance

https://www.tga.gov.au/how-we-regulate/labelling-and-packaging/medicines-and-biologicals/required-advisory-statements-medicine-labels-rasml