KEY changes to the Therapeutic Goods Advertising Code 2018 are likely to be in place as soon as next month, with the aim of providing advertisers with "the clarity they need to apply the code correctly".
In particular, advertising of Schedule 3 medicines will only be required to include the statement "ASK YOUR PHARMACIST - THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU" and not several other statements specified in sections 11, 12 and 13 of the code.
Other key modifications include a new definition of a "health warning" which will be modified to "ensure it only captures those statements critical to the consumer's assessment of the advertised product" and for over-the-counter medicines this will be achieved by a specified schedule of applicable health warnings.
Further adjustments may still emerge around health warnings for complementary medicines and medical devices, the TGA said.
There will be clarification of the requirements for statements in advertisements that need to be "prominently displayed or communicated".
On the matter of scientific referencing, the code guidance will define what is required when there are implied citations such as "clinically proven" which would require identification of the researcher and the financial sponsor of any studies.
The TGA has made clear how it will handle advertising that appears in any form during the new year transition period 01 Jan to 30 Jun.
The priority will be to focus on any claims that pose "a risk to public health and safety".
Education tools and resources are described as a "key focus" and are being developed to help advertisers manage compliance.
As to advertising in specified media that require pre-approval under the 1990 regulations, the requirement for pre-approval will continue until 01 Jul 2020.
The new code is scheduled to take effect from 01 Jan 2019, but the proposed improvements are not anticipated to cause inconvenience to advertisers who have already prepared marketing material based on the existing 2018 code.
The TGA also specifies the way it will assess complaints providing a detailed document at tga.gov.au.
Pre-approval applications decided on or before 31 Dec 2018 will be assessed against the 2015 code, while those on or after 01 Jan 2019 will have the 2018 code applied.
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