QR codes in the labelling and/or package leaflet – veterinary products

A Quick Response (QR) code is a type of matrix bar code that can be read on a mobile device.

With the availability of new communication technologies, it has become apparent that users of veterinary chemical products may benefit from information provided through electronic formats. In this context, there has been interest by registrants and end-users to include QR codes in the labels of veterinary chemical products as an additional method of providing information to animal owners and veterinarians.

The Agvet Code and Regulation requirements

When the Australian Pesticides and Veterinary Medicines Authority (APVMA) refers to veterinary products (also known as veterinary medicines), we mean those items that are defined by the Agricultural and Veterinary Chemicals Code (Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994  as ‘veterinary chemical products’. The Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations) may declare a substance or mixture of substances to be or not be a veterinary chemical product.

The label of a chemical product must be securely attached or affixed to a container prior to supply as prescribed by Agvet Code section 8(1) and Regulation 18C. Regulation 18D requires that a label must state certain information. A label containing only a QR code or referring the user to a copy of the label instructions located on a website would not satisfy either the requirement for the label to be attached or affixed to a container or the requirements of Regulation 18D.

Therefore, the presence of a QR code does not substitute for any of the approved label wording and cannot be contrary to the legislative requirements as set out in Agvet Code Act section 8 and Agvet Regulation 18C and 18D. A QR Code can, however, be a duplication of the marketed label in full or part and may include additional information, such as demonstration videos (may also be related to a device used to administer the veterinary chemical product).

The provisions in the Agvet Code and Regulations in relation to what information may be written on a label for a container would also apply to information available through the QR code. Regulation 18F provides that information must not accompany or be placed on the container, including in the form of another label if the information expressly or impliedly negates or varies information required by regulation 18D(1) to be stated on the label, or qualifies or minimises the substance or effect of the information required by regulation 18D(1).

Adding QR codes to marketed labels

Companies may add QR codes to marketed labels to provide end-users with information relating to a veterinary chemical product. The QR code may be placed on the main or ancillary panel of the label provided it does not obscure or replace label text required by APVMA Labelling Codes, or distract from critical information on the main panel.

The QR code may:

  • provide a link directly to the marketed label and/or leaflet, which must be up-to-date and consistent with the most recent APVMA approval
  • provide a link directly to a video or other visual representation of the product’s directions for use
  • provide a link directly to the Safety Data Sheet
  • direct the end-user to a company website (it is recommended that the website complies with the advertising restrictions for that particular APVMA registered veterinary chemical product).

The information provided through QR codes must not be in contravention with the approved APVMA label.

When adding QR codes to a marketed label (which would continue to state the full details as required by Regulation 18D), the APVMA recommends including a statement close to the QR code stating its purpose or what information the QR Code links to, for example:

  • 'Please scan this QR Code to obtain a copy of the digital veterinary chemical product marketed label and leaflet.’
  • 'Please scan this QR Code for more information about this veterinary chemical product (video demonstration – dosage and administration).’
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