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
<https://www.tga.gov.au/treatment-information-provided-tga>.
Annual product report
Biochemistry Section – TGA Laboratories
Temperature deviations are deemed to have occurred if the shipping temperature has an excursion
from the TGA-approved storage conditions. For example, if the TGA-approved storage conditions
are:
 “Store at 2 to 8°C. Refrigerate do not freeze”, and the shipment spends 12 hours above 8°C but
less than 25°C, this is a temperature deviation.
 as above, but include the additional variation to storage conditions “Up to 3 days at less than
25°C in shipping”, then this would not be a deviation.
Contact [email protected] for further clarification.
Sponsor details
Sponsor name
Postal address
Contact person
Position
Telephone no.
Email address
Report submission details
Agreed submission date
Period covered by report
to
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 Fax: 02 6203 1605 Email: [email protected] https://www.tga.gov.au
Product details summary
Note: These data are for information only, and may be incorporated into the risk assessment tool to determine if any future regulatory action is required.
AustR
Number of
batches released
Product name
TOTALS
Total number
of units
released
Number of nonapproved
temperature
deviations
Reference to
attached
information