TGA use only

This form, when completed, will be classified as 'For official use only'.
For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA at <http://www.tga.gov.au/about/tga-information-to.htm>.

Application for approval of advertising for complementary medicines & over-the-counter medicines

Regulation 5F of the Therapeutic Goods Regulations 1990

/ 1.  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 1990 applies. Section 3 of the Therapeutic Goods Advertising Code (“the 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. "Specified media" means mainstream print media (magazines or newspapers), broadcast media, cinematograph films, displays about goods (including posters) in shopping malls (except inside individual shops); in or on public transport; and on billboards.
2.  All information supplied in this form by the applicant must be either typed or be in block capital letters.
3.  Submit the completed form, together with the required attachments, as follows:
Applications for advertisements for complementary medicines appearing in “specified media” (except broadcast media): / Advertising Services, Complementary Healthcare Council / PO Box 820
MAWSON ACT 2607
Tel: 02 6260 4022
Fax: 02 6260 4122
Email:
Applications for advertisements for OTC products appearing in all specified media and for complementary medicines appearing in broadcast media: / Advertising Services
Australian Self-Medication Industry / PO Box 764
NORTH SYDNEY NSW 2059
Tel. 02 9955 7205
Fax: 02 9957 6204
Email:
4.  Notes about claims:
–  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.
5.  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.
6.  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. Copies of the Code are located on the Therapeutic Goods Advertising Code Council website http://www.tgacc.com.au and the ComLaw website <http://www.comlaw.gov.au.
7.  Privacy information:
·  For general privacy information, go to Privacy on TGA website.
·  Personal information (where applicable) that is collected in this application and/or application form may be used to contact the applicant where necessary and process the application payment.
·  The collection of personal information from this application is authorised under Division 2 of Part 2 of the Therapeutic Goods Regulations 1990.
·  The Complementary Health Care Council (CHC) and the Australian Self-Medication Industry (ASMI) may disclose personal information contained in this application and/or application form to the Therapeutic Goods Administration (TGA), to the Complaints Resolution Panel, to TGA committees and to each other. Credit card information will be disclosed to the appropriate financial institutions for processing payments.
·  The TGA may disclose personal information contained in this application to CHC or to ASMI.

Application for approval of advertising for medicines (June 2014) Page 4 of 4

1.  Applicant details

Company Name of Advertiser or Applicant:
Address:
Contact person: / Email:
Telephone number: / Facsimile number:
Name of Sponsor Company of the Product:
Address:
Contact person: / Email:
Telephone number: / Facsimile number:

2.  Product details

Product type: Complementary medicine OTC medicine

Product Name/s or Product Range / AUST L/R number/s / Product Name/s or Product Range / AUST L/R number/s /

3.  Advertisement type

Magazines/Newspaper / Radio / Cinema
Outdoor/Billboard/Shopping Mall / Television / In/On public transport
Other – please specify

4.  Approval type

New advertisement / Variation of Approval No.
Minor change to Approval No. / Re-approval of Approval No.

5.  Supporting documentation to be attached

Supporting documentation / Attached /
A legible copy of the advertisement
Copy of regulatory documentation i.e. label (enlarged for legibility)
Link to/copy of current indications of use as entered in ARTG (unless exempt)
Copy of any research/surveys/data/studies etc mentioned in advertisement.
Note – further evidence to be provided if requested.
Copy of documentation supporting authenticated testimonials (where used).

6.  Complaints

Has the advertised product/s been the subject of an upheld complaint? / Yes / No
If yes:
Attach the final determinations related to the complaint/s: / Attached
Does the submitted advertisement/s comply with all sanctions? / Yes / No
If the submitted advertisement/s does not comply with all sanctions, attach a justification. / Attached
Have you had withdrawn representations reinstated? / Yes / No
If withdrawn representations have been reinstated, attach verification. / Attached

7.  Applicant declaration and payment

For the Schedule of Fees, please see Fees & payments.

Giving false or misleading information is a serious offence.

I, (print name), declare that the information contained within this application is true and correct.

Total number of pages:

Signature: / Date:
Credit card details
(including type): / Expiry date:

This form has been approved under regulation 5F of the Therapeutic Goods Regulations 1990 by:

Mick O’Connor
Delegate of the Secretary to the Department of Health; and
Director- Advertising and Recalls Section
Office of Product Review
Therapeutic Goods Administration

14 April 2014

Application for approval of advertising for medicines (July 2014) Page 4 of 4

For official use only