Changeover to Therapeutic Goods Advertising Code 2018
The Therapeutic Goods Advertising Code 2018 (2018 Code) was made on 29 June 2018. The following information is provided for advertisers to explain what will happen in the changeover from the 2015 Code to the 2018 Code.
2018 Code effective from 1 January 2019
The 2018 Code takes effect from 1 January 2019. On this date, the 2015 Code will be repealed. However, the 2015 Code will still be relevant in some situations.
Delaying the date for when the 2018 Code takes effect allows advertisers time to familiarise themselves with it and to bring existing advertising material into compliance. The delay will also allow advertisers to undertake the training and education offered by the TGA.
2015 Code amended for S3 (Pharmacist Only) Medicines statement
The Therapeutic Goods Advertising Code 2015 (2015 Code) was amended on 29 June 2018. The only change was to the Schedule 3 (Pharmacist Only) Medicines statement (paragraph 6(3)(e)) to provide advertisers with the choice of using one of two statements:
- YOUR PHARMACIST'S ADVICE IS REQUIRED; or
- ASK YOUR PHARMACIST – THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU
when advertising medicines that are included in Schedule 3 of the Poisons Standard.
Advertisers should note that only statement (ii) will be acceptable when the 2018 Code comes into effect (i.e. from 1 January 2019).
Assessment of applications for advertising pre-approval
Advertisements for medicines that are to appear in specified media require pre-approval under Regulation 5G of the Therapeutic Goods Regulations 1990. The requirement for pre-approval will continue until 1 July 2020.
The date on which an application for pre-approval is received will determine the version of the Code that the application will be assessed against.
For applications for pre-approval received:
|Application received||Assessed against|
On or after 1 January 2019
(This includes minor variations based on advertisements approved before 1 January 2019.)
|On or before 31 December 2018||2015 Code|
Assessment of complaints
For complaints about pre-approved advertisements, compliance will be assessed against the version of the Code under which the advertisement was approved.
For all other advertisements, the version of the Code applied will depend on the date/s on which the advertisement aired or was published:
|Advertising occurred||Assessed against|
|On or after 1 January 2019||2018 Code|
|Before 1 January 2019 and is no longer occurring||2015 Code|
|Before 1 January 2019 and is still occurring||2018 Code|
Advertisers are expected to comply with the Code in force at the time. Advertisers should use the six months between 1 July 2018 and 1 January 2019 to review their current and planned advertising, and ensure that any advertising after 1 January 2019 will be compliant with the 2018 Code (with the exception of advertisements pre-approved under the 2015 Code until the date of expiry of the approval).
TGA is developing advice for advertisers on how the changeover to the 2018 Code will affect restricted representation applications and labelling and packaging (such as where they are subject to pre-market and post-market reviews).
Further information about pre-approval is available from:
- Advertising therapeutic goods - Requirements for pre-approval
- Pre-approvals for advertising
- Reforms to the therapeutic goods advertising framework
For further information, please email TGA.Advertising@tga.gov.au.