Annual Report 2015-16—Index

A

AAT see Administrative Appeals Tribunal

abbreviations, 109–10

absenteeism, 47–48

accountability of corporate governance, 18–19

acronyms, 109–10

actives, applications for, 26–27, 32–34

Administration Act see Agricultural and Veterinary Chemicals (Administration) Act 1992

Administrative Appeals Tribunal, 20

Adverse Experience Reporting Program, 2

advertising, 108

advice, satisfaction with, 37

Advisory Board, 14–15

agency resourcing statement, 52

Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994, 4

Agricultural and Veterinary Chemical Products (Collection of Levy) Regulations 1994, 4

Agricultural and Veterinary Chemical Products Levy Imposition (Customs) Act 1994, 4

Agricultural and Veterinary Chemical Products Levy Imposition (Excise) Act 1994, 4

Agricultural and Veterinary Chemical Products Levy Imposition (General) Act 1994, 4

Agricultural and Veterinary Chemicals (Administration) Act 1992

Audit Committee management of, 13

establishment of Advisory Board under, 14

establishment of the APVMA and powers conferred by, 2–3

Agricultural and Veterinary Chemicals Code

Audit Committee enforcement of, 16

meeting the requirements of, 108

powers and responsibilities conferred by, 2–3

reporting under, 19

Agricultural and Veterinary Chemicals Code Act 1994, 2

Agricultural and Veterinary Chemicals Code Regulations 1995, 2–3

Agriculture White Paper, funding from, ix

Agvet (Code) Regulations see Agricultural and Veterinary Chemicals Code Regulations 1995

agvet chemicals see chemicals

Agvet Code see Agricultural and Veterinary Chemicals Code

ANAO see Australian National Audit Office

annual performance statement, 23–49

appendixes, 93–108

applications

advice about, 37

evaluation of, 6

fast-tracking, ix

fee for, 4, 52

regulation involved in, 39–40

statistics on, 43

timeframes for, 26–29, 32–35

APS Code of Conduct, 47

APVMA regulatory update, 36

Arthy, Kareena, 6 see also Chief Executive Officer

letter of transmittal, iii

report and outlook, ix–xi

assessments see applications; reviews

Audit Committee, 15–16

roles of, 13, 18

Auditor-General's reports, 20

audits

findings of, 48

of correspondence, 37

of good manufacturing practice, 38, 40

of regulated entities, 41

of timeframes to finalise applications, 35

results of, 54

timeframes for, 29

Australian National Audit Office, 15

Australian Regulatory Science Network, x, 46

APVMA Gazette, 19

APVMA operational plan 2015–16 see also annual performance statement

measuring effectiveness through, 12

Strategy 1, 9, 94–97

Strategy 2, 9, 98–101

Strategy 3, 9, 102–04

Strategy 4, 9, 105–06

APVMA Regulator Performance Framework see Regulator Performance Framework

B

Bhula, Raj, 6

budget see Portfolio Budget Statement

C

Carroll, Elizabeth, 7

chemicals

applications for, 25–27

improving access to, xi

review of, 6

role of APVMA regarding, 2–3

safety of, viii

Chief Executive Officer see also Arthy, Kareena

chairing of the Executive Leadership Team, 13

role in Audit Committee, 15

sub-roles of, 5–6

Chief Financial Officer, 15

Chief Information Officer, 15

Chief Operating Officer, 6

Chief Scientist, 7

Code of Conduct of the APS, 47

Codex Alimentarius Commission, x

collaboration of corporate governance, 12

Comcover, insurance with, 21

Commonwealth Ombudsman, 20

communication, performance in, 36–38

compliance, 39–42 see also Legal and Compliance

Chief Executive Officer's report and outlook, x

timeframes for activities related to, 29

with finance law, 3

consultation

Chief Executive Officer's report and outlook, x–xi

corporate governance and, 12

cost of, 54

extent and satisfaction with, 38

with stakeholders, 45

with the public, 47

corporate governance, 11–21

corporate plan, 12 see also APVMA operational plan 2015–16

Corporate Services, 5–6

court cases, xi, 20

customer service standards

adherence to, 37

statistics on, 43

cyber intrusions, 49

D

declarations of interest

by Advisory Board, 15

by Audit Committee, 16

by Manufacturers' Licensing Scheme Industry Liason Committee, 18

Department of Agriculture and Water Resources, communication with, 45

Department of Agriculture and Water Resources, review by, 4

Department of Environment and Energy, transactions with, 19

Department of Health, transactions with, 19

direct sourcing, 54

disability reporting, 21

E

ecological impact, 108

ELT see Executive Leadership Team

employees see staff

enforcement

strategies for, 39–41

timeframes for activities related to, 29

Enforcement Committee, 13

Environment Protection and Biodiversity Conservation Act 1999, 108

environmental impact, 108

environmental scans, 30

equity, 4, 49, 54

Executive Directors, 6–7

Executive Leadership Team, 13

executive management, 5–7

expenditure, 53–54

F

Federal Court matters, xi, 20

feedback, 36–38

mechanisms, 44

figures, list of, vii

finance law, compliance with, 3

financial performance, 48–49

financial statements, 55–90

summary, 51–54

financial reserve, 54

fraud control, 18

functions of the APVMA, 3

funding, 4

G

General Counsel, 7

Global Joint Reviews (GJRs), 31

good manufacturing practice (GMP)

audits, 29, 38, 40

review and improvement of, x

governance see corporate governance; executive management

government policy orders, 3

guidelines

adherence to, 31

use of, 38

H

health and safety see work health and safety

House of Representatives Standing Committee on Agriculture and Industry, xi, 20

I

impediments, removing, 30

import consents, timeframes for, 28

income, 4, 52

indemnities, 21

industry awareness workshops, 30

information requests, 42

information technology, 49

inquiries

Inquiry into agricultural innovation, xi, 20

Inquiry into the Hendra virus (HeV) Equivacc vaccine and its use by veterinary surgeons in Queensland, xi, 20

insurance, 21

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, 46

issues considered

by Advisory Board, 14

by Audit Committee, 16

by Manufacturers' Licensing Scheme Industry Liason Committee, 18

IT, 49

J

Joint Meeting on Pesticides Residues, x

Joyce, Barnaby, 2

judicial decisions, xi, 20

L

Legal and Compliance, 5, 7

letter of transmittal, iii

levies

imposition and collection of, 4

income from, 52

M

Major Projects Board, 13

management see corporate governance; executive management

manufacture see good manufacturing practice

Manufacturers' Licensing Scheme Industry Liaison Committee, 16–18

declarations of interest by, 18

issues considered by, 18

meetings and attendance, 17

terms of reference, 16

market research, 108

medicines see veterinary medicines

meetings and attendance

of Advisory Board, 14

of Audit Committee, 15

of Manufacturers' Licensing Scheme Industry Liason Committee, 17

Minister for Agriculture and Water resources, 2

ministerial directions, 3

mission, viii see also objectives

MLSILC see Manufacturers' Licensing Scheme Industry Liaison Committee

monitoring strategies, 41

N

National Disability Strategy 2010–20, 21

nominal reserve, 4

non-compliance see compliance

Norden, Alan, 6

O

OAIC, reviews by, 20

Oakton, audit by, 35

objectives, 9 see also mission

obtaining information from subsidiaries, 21

OECD

chairing committees of, x

engagement with, 46

Office of the Australian Information Commissioner, reviews by, 20

Office of the Chief Scientist, 5, 7

Ombudsman's investigations, 20

online systems see also website

feedback from, 44

satisfaction with, 32

operational plan see APVMA operational plan 2015–16

organisation, 1–9

Organisation for Economic Co-operation and Development see OECD

Outcome 1, 53 see also performance indicators

P

parliamentary committees, 20

PBS see Portfolio Budget Statement

performance criteria: performance information is published, 43

performance indicators, 24

activities of lower regulatory risk, 40

applications completed within timeframes, 26

business processes, 32

business processes and financial management systems, 48–49

compliance and enforcement activities completed within timeframes, 29

feedback mechanisms, 44

improvements in regulatory science capabilities, 46–47

information requested from regulated entities, 42

international data guidelines, standards and assessments, 31

motivated and trained workforce, 47–48

operating environment for the regulated entities, 30

protect and manage information and enhance information technology, 49

satisfaction with consultative processes, 38

satisfaction with information and guidance materials, 36–38

satisfaction with the quality and timeliness of advice on decisions, 37

performance statement, 23–49

performance statistics, 32

permanent label registration, xi

permits

applications for, 26–27, 32, 34

fee for, 4

granter of, 6

moving to permanent label registration, xi

pesticides see chemicals

PGPA Act see Public Governance, Performance and Accountability Act 2013

planning of corporate governance, 12

policy orders see government policy orders

Portfolio Budget Statement, 12, 24, 49

powers of the APVMA, 2–4

pre-application assistance, x, 37–38

new approach to, x

timeframes for, 28–29

presentations received by Audit Committee, 16

privacy, 19

Privacy Act 1988, 19

Privacy Commissioner, 19

Productivity Commission's Public inquiry into regulation of agriculture, xi, 20

products, applications for, 26–27, 32–33

profile of the APVMA, 2

profit see income

Public Governance, Performance and Accountability Act 2013

Audit Committee management of, 13

non-compliance with finance law, 3

provision of performance statement under, 24

status as corporate Commonwealth entity under, 2

Public inquiry into regulation of agriculture, xi, 20

purchases, quotes required for, 54

purpose of the APVMA, 2

Q

Queensland Parliament's Agriculture and Environment Committee, xi, 20

quotes required for purchases, 54

R

recruitment, 48

Reeves, Phil, 7

Registration Management and Evaluation, 5–6

Registration Quality Committee, 13

registrations see applications

regulation

decisions on, 25, 32

enhancing, 45

regulatory burden, ix, 9, 39–41

Regulator Performance Framework, 12, 43

regulatory science, x, 46–47

Regulatory Science Network, x, 46

removing impediments, 30

renewal fees, 52

reporting, 19, 49

reviews, x–xi, 20 see also consultation; feedback

risk management, ix–x, 39–41, 46–47

corporate, 13, 18

RPF see Regulator Performance Framework

RSN see Australian Regulatory Science Network

S

Saunders, Cate, 6

science, 46–47

Science Quality Committee, 13

Scientific Assessment and Chemical Review, 5–6

scrutiny, xi

security, 49

seminars

on industry information and training, 30

on regulatory science, 46

Senate Estimates Rural and Regional Affairs and Transport Legislation Committee, xi, 20

Senior Leadership Team, 13

service charter, 19

special mentions of staff, 7

staff, 5–8

executive, 13–15

performance of, 47–48

Staff Consultative Committee, 13

stakeholders

engagement with, 12, 38, 44–46

feedback from, 36

forums for, 30

views of, xi

standards

adherence to, 31

adoption of international standards, 38

setting, x

statutory notices, 29

statutory provisions, 107–08

strategies

compliance, monitoring and enforcement, 39–41

National Disability Strategy 2010–20, 21

regulatory science, 46

Strategy 1, 9, 94–97

Strategy 2, 9, 98–101

Strategy 3, 9, 102–04

Strategy 4, 9, 105–06

subsidiaries, 21

sustainability, 108

T

tables, list of, vi–vii

terms of reference of Manufacturers' Licensing Scheme Industry Liason Committee, 15

timeframes

completion of processes within, 26–29

for applications, 32–35

for regulatory science projects, 47

improving adherence to, ix

statistics on, 43

training, 47–48

transactions, 19

transparency, 42–44

tribunals, 20

U

United Nations, engagement with, x

V

veterinary medicines, 25–27

VICH, engagement with, 46

virus attacks, 49

vision, viii

W

website, 32, 36

science pages on, 46

WHO, engagement with, x

work health and safety, 49, 107

Work Health and Safety Committee, 13

workforce see staff

Working Group on Pesticides, x

World Health Organization, engagement with, x