Analysis by type of application

1. Summary of activities related to regulatory decisions – June quarter 2021

Types of regulatory decisions	Commenced	Finalised/issued	In progress
Pre-application assistance	50	57	39
Product registration – pesticides	271	291	387
Product registration – veterinary medicines	163	158	230
Permits	176	155	248
Actives	68	78	143
Items 8L, 8M, 8P	292	132	210
Technical assessment (Item 25)	2	1	9
Notifiable variations	204	204	0
Import consents	153	194	5
Certificates of export	171	168	21
Total	1 550	1 438	1 292

* See description of application types

1.1. Applications processed – June quarter 2021

Type	Commenced	Finalised	Finalised within timeframe	2019–20 in timeframe	In progress	In progress still within timeframe
Pesticides	271	291	99%	92%	387	97%
Veterinary medicines	163	158	100%	89%	230	96%
Total products	434	449	99%	91%	617	97%
Permits	176	155	70%	81%	248	81%
Actives	68	78	99%	85%	143	94%
Total	678	682	93%	88%	1 008	92%

2. Pre-application assistance

In the June quarter 2021:

• 50 applications were received
• 57 applications were finalised
• 39 applications were in progress at the end of the quarter.

2.1. Pre-application assistance – June quarter 2021

Type	Received	Finalised	Within timeframe	In progress
Tier 1 (1 month)	10	15	12	5
Tier 2 (2 months)	33	39	20	26
Tier 3 (3 months)	7	3	2	8
Total	50	57	34	39

* This includes all PAAs received under the previous process.

Pre-application assistance (PAA) is an optional, three-tiered, fee-based service for applicants to provide them with advice before they submit an application for registration. The timeframe for each tier is based on the complexity of the proposed application and effort required to provide the assistance.

3. Preliminary assessment

Preliminary assessment is a legislatively required administrative check of all applications to ensure the information necessary to proceed to a full evaluation is present. The timeframe for preliminary assessment is one month from lodgement.

In the June quarter 2021:

• 621 were received
• 628 were processed
• 99% were completed within timeframe.

3.1. Preliminary assessment – June quarter 2021

Application type	Received	Completed	Refused	Withdrawn	Within timeframe
Pesticides	279	264	0	0	98%
Veterinary medicines	119	111	0	1	99%
Total products	398	375	0	1	99%
Permits	152	180	0	6	98%
Actives	71	73	0	1	100%
Total	621	628	0	8	99%

4. Applications commenced

In the June quarter 2021, 678 applications were commenced.

• 434 for products
• 176 for permits
• 68 for actives

5. Applications finalised

In the June quarter 2021, 682 applications were finalised.

• 449 for products
• 155 for permits
• 78 for actives

6. Timeframe performance

In the June quarter 2021, timeframe performance results for applications were:

• 99% for pesticide products
• 100% for veterinary medicines products
• 70% for permits
• 99% for actives.

7. Work in progress

At the end of June quarter 2021, there were:

• 1008 applications in progress:
  • 617 product applications
  • 248 permit applications
  • 143 active applications.

92% were within timeframe.

Work in progress is an indicator of the current workload of the APVMA. It is calculated as the number of applications still in evaluation at the end of the quarter.

8. Technical assessment, notifiable variations, holders and nominated agents

In June quarter 2021:

• 1 technical assessment on data packages was finalised
• 132 applications to change (or create) a holder or nominated agent (Item 8L, 8M, 8P) were finalised
• 204 minor changes to the details of a registered product, active or label (notifiable variations) were finalised.

8.1. Other regulatory assessments – June quarter 2021

Assessment type	Commenced	Finalised	In progress	Finalised within timeframe (%)
Technical assessments	2	1	9	100%
Items 8L, 8M, 8P	292	132	210	100%
Notifiable variations	204	204	0	100%

9. Consents to import

In June quarter 2021, 173 consents to import were issued.

9.1. Consents to import – June quarter 2021

Quarter	Received	Finalised	Issued	In progress	Finalised within targeted time (%)
June 2021	153	194	173	5	89%

Consents to import are issued to allow importation – in limited circumstances – of unregistered products or unapproved actives into Australia when a legitimate reason exists for a person or company to have possession of the chemicals in Australia. There is no statutory timeframe for consents to import – the APVMA seeks to process these within 14 days.

10. Certificates of export

In the June quarter 2021, 90 certificates of export were issued.

10.1. Certificates of export – June quarter 2021

Quarter	Received	Issued	Not issued	In progress	Finalised within targeted time (%)
June 2021	171	168	1	21	77%

Before accepting exports of a chemical product from Australia, many countries require an assurance from the government authority responsible for regulating the product in Australia. This is provided by the APVMA in the form of a certificate of export. There is no statutory timeframe for certificates of export – the APVMA seeks to process these within 20 days.