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Annual performance statistics report: July 2018 to June 2019
Print version
21 October 2019
14. Pharmacovigilance inspection program (PVIP)
| 2017-18[a] | 2018-19 | |
|---|---|---|
| July to June | ||
| Compliance investigation category | ||
| Total inspections completed | 5 | 10 |
| Total with completed findings | 5 | 7 |
| Critical deficiencies[b] | 0 | 1 |
| Major deficiencies[c] | 25 | 34 |
| Minor deficiencies[d] | 12 | 24 |
| Average deficiencies per inspection |
0 critical 5 major 2 minor |
0 critical 5 major 3 minor |
Footnotes
| [a] | Inspections commenced in January 2018, so the 2017-18 figure represents a half-year of data. |
|---|---|
| [b] | A deficiency in pharmacovigilance systems, practices or processes that adversely affects the rights, safety or well-being of patients or that poses a potential risk to public health or that represents a serious violation of applicable legislation and guidelines. Deficiencies classified as critical may include a pattern of deviations classified as major. A critical deficiency also occurs when a sponsor is observed to have engaged in fraud, misrepresentation or falsification of data. |
| [c] | A deficiency in pharmacovigilance systems, practices or processes that could potentially adversely affect the rights, safety or well-being of patients or that could potentially pose a risk to public health or that represents a violation of applicable legislation and guidelines. Deficiencies classified as major may include a pattern of deviations classified as minor. |
| [d] | A deficiency in pharmacovigilance systems, practices or processes that would not be expected to adversely affect the rights, safety or well-being of patients. A deficiency may be minor either because it is judged as minor or because there is insufficient information to classify it as major or critical. |