TGA Early Warning System
June 5, 2013
AUSTRALIA’S Therapeutic Goods
Administration and Medsafe,
its New Zealand counterpart,
have released details of new
parallel early warning systems
to communicate potential safety
concerns with therapeutic products.
The system includes current and
historical information on safety
concerns for both medicines and
medical devices, which have been
identified via the agencies’ product
vigilance programs.
Two types of communications
can be issued as part of the Early
Warning System: Monitoring
Communications, intended
to highlight potential safety
concerns and encourage further
reporting and research; and Alert
Communications, which are issued
once a safety concern has been
investigated, providing advice on
actions which may be needed by
health professionals and consumers.
In contrast to Recall
Communications, the TGA says
an Early Warning System alert
does not necessarily mean that a
product is considered to be unsafe.
A full document describing the
processes and decision trees
involved with the Early Warning
System in both countries is now
available on the TGA website, and
can be accessed by CLICKING HERE.
The above article was sent to subscribers in Pharmacy Daily's issue from 05 Jun 13To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 05 Jun 13
Warning: Undefined variable $flipbook_id in
/home/pharmacydaily.com.au/public_html/wp-content/themes/child-custom-theme/functions.php on line
1259
Warning: Undefined variable $o_shortcode_atts in
/home/pharmacydaily.com.au/public_html/wp-content/themes/child-custom-theme/functions.php on line
1263
Warning: Undefined variable $output in
/home/pharmacydaily.com.au/public_html/wp-content/themes/child-custom-theme/functions.php on line
1266
