Revised ad consultation

THE Therapeutic Goods Administration (TGA) is seeking further feedback on major changes to advertising for therapeutic goods, after stakeholders making submissions to an earlier consultation ( PD 22 Jan) called for further opportunities to provide more input on the initiative.

Yesterday the TGA released a revised version of the guidance to support the new Therapeutic Goods Advertising Code 2018, with interested parties asked to respond by Thu 04 Oct 2018.

Comments are particularly sought on proposed guidance around the use of “natural” claims in the advertising of therapeutic goods; the concept of a “reasonable consumer” as referenced in the code; a proposal to make definitions in Appendix 1 of the proposed Code guidance available via hyperlinks to the TGA website glossary rather than enshrining them in the actual document; and the use of a crossreference to the World Health Organization Framework for Ethical Criteria for Medicinal Drug Promotion.

Key differences from the previous 2015 Code include changes to the mandatory statement required in advertising for Schedule 3 (pharmacist-only) medicines, along with a stipulation that advertising must not undermine public health campaigns.

There’s also a revised definition for deciding whether the use of the word “serious” when referring to a disease, condition, ailment or defect is a restricted representation, and special requirements that apply to the advertising of sunscreens.

View the revised consultation document at www.tga.gov.au.