Advertising of therapeutic products is closely
controlled under the Therapeutic Goods Advertising Code
(TGAC). Only claims which have been included in the
application for marketing submission may be used in
advertising so it is important to ensure that all documentable
claims are submitted when applying for listing or
registration.
The TGA issues a set of guidelines which
specify the documentation required and the Consultancy can
guide sponsors in this regard.
For registered products the documentation must
be submitted with the application however for listed goods a
statutory declaration is made that the sponsor hold the proof.
At any time the TGA are entitled to ask for this proof and
spot check at least 10% of all applications.
The Consultancy can have the documentation
searched but this is a separate charge at the normal hourly
rate since there is no set time involved and can be very time
consuming.
All advertising must be submitted to the
Industry Association, the Complementary Healthcare Council
(CHC), for print media and the Australian Self Medication
Industry Association (ASMI) for TV and radio.
The Consultancy can assist in checking
advertising and submitting on behalf of clients. The various media will not accept advertising unless
it has an approval number.
The
consultancy can check all advertising copy for conformity with
Listing or Registration approvals and advise on suitable
wording plus write Product Information and Consumer
Information documents. We can submit copy for approval and
negotiate with clearance officers when
needed.