AJOR
ESEARCH
ROJECT
S
WINBURNE
U
NIVERSITY OF
T
ECHNOLOGY
Lina Karlina 2067226
Page 20 of 25
procedure would not be simple since it has to pass through assessment and regulation amendments DoHA, 2011.
To the consumer: Consumer will be more protected from misleading and unsubstantiated claims
and indications. This is crucial especially when the sponsors do not hold evidence to support the safety of their products.
4.2.4 Enhancing post-market monitoring
To the industry: Since a risk-
based approach will be implemented on the TGA’s post-market monitoring program through the utilisation of risk profiles of sponsors and
products characteristics which means products that pose high probability of non- compliant and sponsors who frequently incompliant will be more often
subjected to post-market monitoring Harvey, 2012. Therefore, this reform encourages the industry to continuously comply with regulatory requirements.
To the consumer: This will provide greater assurance to consumer that the listed complementary
medicines reviewed by the TGA are proven to be safe, manufactured in GMP licensed facility, of good quality and effective. On the other hand, consumer
may become unsure in regards to the safety, quality and efficacy of listed complementary medicines that have not been reviewed since post-market
monitoring is performed only on a small percentage of the medicines.
4.2.5 Publishing outcomes of listing compliance reviews
To the industry: Providing the results of listing compliance reviews to public through the TGA
website resulted in positive and negative impact to the industry. The publication
AJOR
ESEARCH
ROJECT
S
WINBURNE
U
NIVERSITY OF
T
ECHNOLOGY
Lina Karlina 2067226
Page 21 of 25
may be considered as free promotion media by notifying the public that their products have been reviewed and passed all the regulatory requirements.
Nevertheless, it results in different situation when the products did not pass the review.
Moreover, the company’s reputation may be damaged when the companies were given sanctions or financial penalties by the TGA and the
medicine reviewed or other medicines produced by the company may be in questioned by consumer in regards to its safety, quality and efficacy. Consumer
may question the safety, quality and efficacy of the product reviewed even if the product was only incompliant with some aspects of the regulatory requirements.
To the consumer: Publication of the outcomes of listing compliance reviews on the TGA website
provides easy access for consumer to obtain information on complementary medicines that have been reviewed as well as the outcomes which will greatly
assist the consumer in making well-informed decision associated with complementary medicines use.
4.2.6 Permitted coded indications project
This measure will be taken to support the previous action planned by the TGA which is the update to the listed medicines electronic application portal.
Therefore, the impact are more likely to be similar. To the industry:
The sponsors are only allowed to use indications permitted in the list which have been assessed by the TGA. This project limits the sponsors that previously
used the free-text field to deliberately make misleading claims and indications for commercial purposes Harvey, 2012.
To the consumer: The indications available on the label of complementary medicines packaging
would be those permitted by the TGA and appropriate for low risk medicines.
AJOR
ESEARCH
ROJECT
S
WINBURNE
U
NIVERSITY OF
T
ECHNOLOGY
Lina Karlina 2067226
Page 22 of 25
Accordingly, it will prevent the consumers from being exposed to misleading and inappropriate indications.
4.2.7 Investigation process for advertising breaches
