Ad­ver­tis­ing code changes

Pharmacy Daily - - Front page -

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 over­the-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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