Application for advertising approval
From 1 February 2018, medicines containing codeine will be available on prescription only. This may affect your application for approval to advertise codeine medicines to the public.
For more information, see Changes to advertising for medicines containing codeine.>
This form has been prepared to assist in the process of applying for the approval of advertisements in "specified media" to which Division 2 of Part 2 of the Therapeutic Goods Regulations applies.
Section 3 of the Therapeutic Goods Advertising Code provides that applications for approval of therapeutic goods appearing in "specified media" must be approved by the appropriate Advertising Services Manager for compliance with the Code.
This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.
- Application for approval of advertising for medicines (pdf,147kb)
- Application for approval of advertising for medicines (Microsoft Word,140kb)
- New - a completely new advertisement.
- Re-approval - re-approval of an identical advertisement whose approval number has expired.
- Minor change - typographical error, changed sponsor contact details or a change in the address/location from where the advertised goods are available.
- Variation - cut down of an existing advertisement. A variation does not allow for the addition of any new matter, including new claims.
For Schedule of Fees, please see - Fees & payments
"Specified media" means mainstream print media (magazines or newspapers), broadcast media, cinematograph films and displays about goods (including posters):
- in shopping malls (except inside individual shops); and
- in or on public transport; and
- on billboards.
Please send applications for approval of advertisements to the appropriate Advertising Services Manager:
Applications for advertisements for complementary medicines appearing in "specified media" (except broadcast media):
Office of Advertising Compliance
Complementary Healthcare Council
PO Box 820, MAWSON ACT 2607
Tel: 02 6260 4066
Fax: 02 6260 4122
Applications for advertisements for OTC products appearing in all specified media and for complementary medicines appearing in broadcast media:
Australian Self-Medication Industry
PO Box 764, NORTH SYDNEY NSW 2059
Tel: 02 9955 7205
Fax: 02 9957 6204
- Substantiation of all claims must be provided upon request.
- The relevant Advertising Services Manager may request substantiation of claims (in line with levels of evidence) that the sponsor is required to hold at the time of registration or listing.
- Notwithstanding the above, further substantiation may also be requested.
- A claim / indication entered on the ARTG will not automatically be approved as an advertising claim.
- Advertisements should not be booked for publication prior to approval being granted and an approval number being allocated to the advertisement, or before entry of the product onto the ARTG.
Applications for the approval of an advertisement must comply with the relevant provisions of the therapeutic goods legislation including the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations and the Code.