Analysis by type of application

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

Types of regulatory decisions	Commenced	Finalised/issued	In progress
Pre-application assistance	55	49	42
Product registration – pesticides	269	334	407
Product registration – veterinary medicines	157	153	224
Permits	140	162	230
Actives	56	78	152
Items 8L, 8M, 8P	205	190	50
Technical assessment (Item 25)	4	5	8
Notifiable variations	197	201	11
Import consents	200	186	2
Certificates of export	92	90	12
Total	1,375	1,448	1,138

* See description of application types.

Applications processed – March quarter 2021

Type	Commenced	Finalised	Finalised within timeframe	2019–20 in timeframe	In progress	In progress still within timeframe
Pesticides	269	334	99%	92%	407	99%
Veterinary medicines	157	153	99%	89%	224	96%
Total products	426	487	99%	91%	631	98%
Permits	140	162	70%	81%	230	67%
Actives	56	78	96%	85%	152	95%
Total	622	727	92%	88%	1,013	91%

2. Pre-application assistance

In the March quarter 2021:

• 55 applications were received
• 49 applications were finalised
• 42 applications were in progress at the end of the quarter.

Pre-application assistance – March quarter 2021

Type	Received	Finalised	Within timeframe	In progress
Tier 1 (1 month)	23	16	11	12
Tier 2 (2 months)	30	28	18	28
Tier 3 (3 months)	2	5	3	2
Total	55	49	32	42

* 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 March quarter 2021:

• 573 were received
• 551 were processed
• 98% were completed within timeframe.

Preliminary assessment – March quarter 2021

Application type	Received	Completed	Refused	Withdrawn	Within timeframe
Pesticides	252	270	0	0	99%
Veterinary medicines	101	91	0	0	100%
Total products	353	361	0	0	99%
Permits	171	141	0	2	100%
Actives	49	49	2	0	90%
Total	573	551	2	2	98%

4. Applications commenced

In the March quarter 2021, 622 applications were commenced.

• 426 for products
• 140 for permits
• 56 for actives

5. Applications finalised

In the March quarter 2021, 727 applications were finalised.

• 487 for products
• 162 for permits
• 78 for actives

6. Timeframe performance

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

• 99% for pesticide products
• 99% for veterinary medicines products
• 70% for permits
• 96% for actives.

7. Work in progress

At the end of March quarter 2021, there were:

• 1013 applications in progress:
  • 631 product applications
  • 230 permit applications
  • 152 active applications.

91% 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 March quarter 2021:

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

Other regulatory assessments – March quarter 2021

Assessment type	Commenced	Finalised	In progress	Finalised within timeframe (%)
Technical assessments	4	5	8	100%
Items 8L, 8M, 8P	205	190	50	84%
Notifiable variations	197	201	11	100%

9. Consents to import

In March quarter 2021, 186 consents to import were issued.

Consents to import – March quarter 2021

Quarter	Received	Finalised	Issued	In progress	Finalised within targeted time (%)
March 2021	200	198	186	2	57%

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 March quarter 2021, 90 certificates of export were issued.

Certificates of export – March quarter 2021

Quarter	Received	Issued	Not issued	In progress	Finalised within targeted time (%)
March 2021	92	90	3	12	74%

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.