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Half yearly performance report - January to June 2015

16 December 2015

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11. Regulatory compliance

Using signals from numerous sources as intelligence, the TGA Regulatory Compliance Unit conducts compliance and enforcement activities against a risk based compliance framework. Using principles of responsive regulation, a range of tools are used including encouragement and guidance to comply, restrictions or warnings, suspensions or sanctions and cancellations. At the apex, activities including investigations into illegal import or manufacture of unapproved and counterfeit therapeutic goods can result in criminal or civil court action. All compliance activities have the intended purpose to protect public health.

Table 59: Regulatory compliance investigations by final action taken
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Investigation in progress 257 168 73
Completed investigations
Warned 371 291 398
No offence detected 100 82 59
Goods released under Personal Import Scheme 33 29 45
Referred to another agency or department outside Health 8 5 4
Referred to another branch within the TGA 8 1 3
Import treated as abandoned goods by Customs 0 0 0
Recall of goods 2 0 0
Matters referred to the Commonwealth Director of Public Prosecutions 3 0 1
Total completed 525 408 510
Table 60: Types of products investigated
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Complementary medicines 421 260 226
Prescription medicines 318 383 477
Medical devices 100 81 75
Homoeopathic medicines 1 2 2
OTC medicines 9 32 54
Biological products 0 5 25
Other 18 14 17
Total 867 777 876
Table 61: Regulatory compliance investigations by special interest categories
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Unapproved product 678 677 727
Counterfeit product 172 92 140
Parallel import/export 2 0 1
Manufacture without licence 1 0 0
Advertising offence 0 1 2
Traditional Chinese medicines 0 1 0
Other1 6 2 2
Total 859 773 872
  1. Products that fall outside the remit of the Therapeutic Goods Act 1989, for example Food products
Table 62: Investigations by complainant type and state/territory for January to June 2015
Origin ACT NSW NT QLD SA VIC WA Othera Total
Complaints resolution 3 8 0 1 0 0 0 0 12
Customs 1 200 5 64 4 105 42 2 423
External agency 5 11 0 5 1 1 0 0 23
General public 0 12 1 10 1 10 1 68 103
Patient/ practitioner 0 0 0 0 0 0 0 1 1
Sponsor/client 0 0 0 0 0 1 0 3 4
TGA internal 25 0 0 0 0 0 0 0 25
Total 34 231 6 80 6 117 43 74 591
  1. Other includes investigations of reports from Tasmania and anonymous (unknown) origin.

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