On this page
Summary of activities related to regulatory decisions – March quarter 2024
| Types of regulatory decisions | Received | In progress | Processed |
|---|---|---|---|
| Pre-application assistance | 40 | 59 | 39 |
| Product registration – pesticides | 214 | 416 | 187 |
| Product registration – veterinary medicines | 198 | 253 | 177 |
| Permits (excluding emergency) | 156 | 240 | 107 |
| Emergency permits (Item 22) | 21 | 12 | 20 |
| Actives | 91 | 238 | 119 |
| Items 8L, 8M, 8P | 147 | 134 | 13 |
| Technical assessment (Item 25) | 2 | 9 | 2 |
| Notifiable variations | 221 | 0 | 221 |
| Import consents | 282 | 60 | 225 |
| Certificate of export | 110 | 17 | 132 |
| Interchangeable constituent determination | 0 | 1 | 1 |
| Total | 1 482 | 1 439 | 1 243 |
See description of application types.
Applications processed
| Type | Received | In progress | Processed | Processed on time (%) | In progress still on time (%) |
|---|---|---|---|---|---|
| Actives | 91 | 238 | 119 | 94.1% | 93.7% |
| Emergency permits (Item 22) | 21 | 12 | 20 | N/A | N/A |
| Permits (excluding emergency) | 156 | 240 | 107 | 90.7% | 87.1% |
| Pesticides | 214 | 416 | 187 | 95.2% | 88.7% |
| Veterinary medicines | 198 | 253 | 177 | 98.9% | 91.7% |
| Total | 680 | 1 159 | 610 | 95.3% | 90.1% |
Note: Emergency permits (Item 22) do not have a numerical statutory timeframe. The APVMA must determine the application as soon as is practicable in the circumstances of the case (see Emergency permits).
Pre-application assistance
Pre-application assistance (PAA) is an optional, 3 tiered, fee-based service for applicants to provide them with advice before they submit an application for registration. PAAs do not have a numerical statutory timeframe; the target timeframe for each tier is based on the anticipated complexity of the proposed application and effort required to provide the assistance.
| Type | Received | In progress | Processed | Processed on time (%) |
|---|---|---|---|---|
| PAA Tier 1 | 13 | 13 | 7 | 14.3% |
| PAA Tier 2 | 26 | 41 | 30 | 6.7% |
| PAA Tier 3 | 1 | 5 | 2 | 0.0% |
| Total | 40 | 59 | 39 | 7.7% |
Emergency permits
Emergency permits (Item 22) do not have a numerical statutory timeframe. The APVMA must determine the application as soon as is practicable in the circumstances of the case.
| Types of regulatory decisions | Received | In progress | Processed | Issued | Refused | Withdrawn or Other |
|---|---|---|---|---|---|---|
| Emergency permits (Item 22) | 21 | 12 | 20 | 17 | 2 | 1 |
Technical assessment, notifiable variations, holders and nominated agents
| Types of regulatory decisions | Received | In progress | Processed | Processed on time (%) |
|---|---|---|---|---|
| Items 8L, 8M, 8P | 147 | 134 | 13 | 100.0% |
| Technical assessment (Item 25) | 2 | 9 | 2 | 100.0% |
| Notifiable variations | 221 | 0 | 221 | 100.0% |
Consents to import
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.
| Types of regulatory decisions | Received | In progress | Processed | Processed on time (%) |
|---|---|---|---|---|
| Import consents | 282 | 60 | 225 | 97.3% |
Certificates of export
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 working days. Please note that an application may request multiple certificates.
| Received | In progress | Processed | Issued | Processed on time (%) | |
|---|---|---|---|---|---|
| Applications | 110 | 17 | 132 | 129 | 53.8% |
| Certificates | 289 | 57 | 272 | 267 | 69.5% |