Therapeutic goods advertising: update 31 July 2019

Minor corrections and clarifications have been made to the Therapeutic Goods Advertising Code (No.2) 2018 (the Code) - external site. These came into effect on 30 July 2019. More information is provided below.

We are also taking this opportunity to:

• update medicine advertisers on a change in name and address for the Australian Self-Medication Industry, and
• clarify advertising pre-approval application arrangements, including those for catalogues containing a mix of different medicine types, and timeframes.

Changes to the Therapeutic Goods Advertising Code (No.2) 2018

The Therapeutic Goods Advertising Code (No.2) 2018 (the Code) came into effect on 1 January 2019. Following feedback from industry and the Therapeutic Goods Advertising Consultative Committee (TGACC), we have identified and made minor corrections and clarifications to the Code. These amendments - external site are effective from 30 July 2019.

Key corrections and clarifications

The amendment instrument - external site contains a full list of the changes made to the Code. Key amendments include:

• clarifications to the definition of 'health warnings' for medical devices and other therapeutic goods (section 4);
• clarification that the section 11 mandatory statement applies to advertising of any therapeutic good that includes a Schedule 3 substance when the advertising is permitted by inclusion of the substance in Appendix H of the Poisons Standard;
• provision for advertisers to vary the wording of the indications or intended purpose used in the advertisement from that included on the good's label or instructions for use - provided that it does not differ in meaning or intent (sections 12 and 13);
• a change to section 13 to clarify that, for the purposes of that section, the test for whether there is a health warning for a medicine is limited to the inclusion of an ingredient listed in Part 1 or Part 2 of Schedule 1 (i.e. Parts 3 and 4 are not relevant);
• clarification that if an advertisement for therapeutic goods contains only the name of the goods, a picture of the goods (packshot), the price of the goods or where the goods may be purchased, or any combination of these, Section 13 does not apply. However, if any therapeutic claims are visible or implied (e.g. in the name of the product or on the label in a packshot, Section 13 does apply.
• clarification that references to pregnancy, other than complicated pregnancies, are not captured as restricted representations (section 28).

We have also taken the opportunity to provide advertisers with the option to use a single mandatory statement when telling consumers to 'read the label' when advertising multiple medicines at once (section 13(2A)).

Further information about the changes is available from the explanatory statement - external site.

We consulted with the TGACC prior to making these corrections and clarifications and incorporated member feedback where appropriate.

These changes are effective from 30 July 2019. A consolidated Code containing the amendments will also be published. We are also updating the guidance to reflect the changes to the Code. Further announcements will be made when the consolidated Code and revised guidance is published.

Which version of the Code applies when?

Medicine advertising pre-approvals

When deciding whether to approve an application for pre-approval of medicines advertising in specified media, the Advertising Services Managers (ASM) will apply the amended Code to all decisions made from 30 July 2019, irrespective of the date on which the application was received.

As the amendments to the Code are minor in nature and also provide advertisers with additional flexibility, they are not expected to impact applications under consideration at the time the Code amendments were made.

Compliance

When considering complaints about the advertising of therapeutic goods, the TGA will consider:

• for pre-approved advertising of medicines - the Code in force at the time the advertising was approved (provided the approval has not expired or been withdrawn)
• for all other advertising from 1 January 2019 onwards - the Code as amended.

No transition arrangements have been implemented with the amendments to the Code as the amendments to the Code are minor in nature.

Important information about applications for medicine advertising pre-approval

Change in name and address for Australian Self-Medication Industry

The Australian Self-Medication Industry (ASMI) is now Consumer Healthcare Products Australia (CHP Australia). CHP Australia has also relocated from North Sydney to St Leonards. The name change does not affect CHP Australia's authority to approve advertisements.

Applications for advertisements for OTC medicines in specified media and for complementary medicines appearing in broadcast media should now be sent to:

Advertising Services
Consumer Healthcare Products Australia (CHP Australia)
PO Box 209, ST LEONARDS NSW 1590
Tel: 02 9955 7205
Email: advertising@chpaustralia.com.au

We are updating the application form to reflect these new details.

Catalogues

Catalogues are commonly used by retailers (such as pharmacies) to advertise therapeutic goods to consumers. Pharmacy catalogues, in particular, often contain a mixture of complementary medicines, over-the-counter medicines and medical devices. Medicine advertisements to appear in catalogues will generally require pre-approval under the Therapeutic Goods Regulations 1990 before being printed.

If you intend to advertise complementary medicines and other medicines in the same catalogue, it is your responsibility to get approvals from both Advertising Services Managers (ASMs), namely:

• the Complementary Healthcare Council of Australia, for complementary medicines and
• Consumer Healthcare Products Australia, for all other kinds of medicines.

Where a catalogue (rather than the individual medicine advertisement) has been lodged for pre-approval, the approval will indicate to which specific medicines the approval applies.

Timeframes for deciding applications and extensions

Under the Therapeutic Goods Regulations 1990 (the Regulations), an application lodged for pre-approval of medicines advertising in specified media must be decided within 60 days (see subregulation 5H(2)).

When preparing an application for pre-approval, you should note that the different Advertising Services Managers (ASMs) may have different processes that you will need to factor in when planning your advertising and application. These processes will include, where necessary, sufficient time to write formal reasons for a decision. Further information on processes is available from the ASMs - see Complementary Healthcare Council of Australia - external site and Consumer Healthcare Products Australia - external site.

The Regulations do allow for extensions to timeframes by mutual agreement between the ASM and the applicant. If you need additional time to respond to queries raised by a delegate, you can request an extension in writing. However, if you provide a significant amount of information to an ASM and they request additional time to assess that information, failure to agree to that request may adversely affect your application.