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 |
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 |
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%) |
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%) |
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%) |
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 |
