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Annual performance statistics report: July 2018 to June 2019

21 October 2019

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13. Regulatory compliance

The TGA conducts compliance and enforcement activities against a risk based compliance framework. A range of tools are utilised to encourage compliance and address non-compliance including education and guidance, warnings, the issue of infringements, or product suspensions or cancellations. Investigations may also result in criminal or civil court proceedings. All compliance activities have the purpose of protecting public health.

Due to changes in the IT data capture process in December 2017 the categories against which data is presented has been altered. The tables below have been updated to reflect these changes.

Table 73 Number of compliance actions taken against completed investigations
2017-18 2018-19
July to June
Number (% of Total)
Completed investigations
Criminal prosecution 2 (0.1%) 1 (0.1%)
Infringement notices 0 (0%) 9 (0.3%)
Warning letters issued[a] 2173 (73%) 2489 (72%)
Goods released under Personal Import Scheme 324 (11%) 534 (15%)
Referred to external agency 58 (2%) 86 (3%)
Referred to the Commonwealth Director of Public Prosecutions 3 (0.1%) 5 (0.1%)
Referred internally 28 (1%) 91 (3%)
No offence identified 397(13%) 248 (7%)
Total[c] 2985 (100%) 3463 (100%)
Units of goods referred to ABF for destruction[b] 850514 1069946

Footnotes


Table 74 Regulatory compliance investigations by number
2017-18 2018-19
July to June
Compliance cases[a]
Cases received 3574 3658
Cases active 17 400
Cases finalised 3976 3271

Footnotes


Table 75 Number of different products investigated
2017-18 2018-19
July to June
Number (% of Total)
Therapeutic good type
Prescription medicines (Schedule 4 and Schedule 8) 1319 (56%) 1650 (51%)
Schedule 9 medicines 8 (0.4%) 10 (0.3%)
Schedule 10 medicines 18 (0.8%) 20 (0.6%)
Medical devices 27 (1%) 40 (1%)
Complementary and homoeopathic medicines 400 (18%) 353 (11%)
OTC medicines 98 (4%) 75 (2%)
Biological and blood products 11 (0.5%) 14 (0.4%)
Other[a] 472 (21%) 1074 (33%)
Total[b] 2353 (100%) 3236 (100%)

Footnotes


Table 76 Regulatory compliance investigations by special interest categories
2017-18 2018-19
July to June
Number (% of Total)
Compliance investigation category
Unregistered 3851 (95%) 3544 (96%)
Registered 14 (0.3%) 11 (0.3%)
Counterfeit product 173 (4%) 121 (3%)
Other 25 (0.6%) 17 (0.5%)
Total[a] 4063 (100%) 3693 (100%)

Footnotes


Table 77 Number of offence types related to completed cases
2017-18 2018-19
July to June
Number (% of Total)
Offence type
Import 5720[a] (90%) 4388 (87%)
Export 6 (0.1%) 5 (0.1%)
Manufacture 32 (0.5%) 63 (1%)
Supply 542 (9%) 605 (12%)
Total completed[b] 6300 (100%) 5061 (100%)

Footnotes


Table 78 Location of alleged offence by referral type for July 2018 to June 2019
Origin ACT NSW NT QLD SA VIC WA TAS Total
Australian Border Force 31 423 173 521 288 1268 97 60 2861
External Agencies, Other Regulatory Body, State Health Department 0 3 1 1 0 4 38 0 47
General public 0 18 0 14 2 15 224 1 274
Sponsor/client, Patient/Practitioner 0 1 1 2 0 6 55 0 65
TGA internal[a] 0 23 0 13 3 8 70 1 118
Total 31 468 173 551 293 1301 484 62 3671

Footnotes


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