On this page
Summary of activities related to regulatory decisions – June quarter 2024
| Types of regulatory decisions | Received | In progress | Processed |
|---|---|---|---|
| Pre-application assistance | 50 | 65 | 44 |
| Product registration – pesticides | 180 | 387 | 209 |
| Product registration – veterinary medicines | 178 | 264 | 167 |
| Permits (excluding emergency) | 155 | 265 | 130 |
| Emergency permits (Item 22) | 18 | 15 | 15 |
| Actives | 102 | 250 | 90 |
| Items 8L, 8M, 8P | 212 | 8 | 338 |
| Technical assessment (Item 25) | 5 | 11 | 3 |
| Notifiable variations | 162 | 0 | 162 |
| Import consents | 119 | 13 | 163 |
| Certificate of export | 92 | 21 | 89 |
| Interchangeable constituent determination | 0 | 0 | 1 |
| Total | 1 273 | 1 299 | 1 411 |
See description of application types.
Applications processed
| Type | Received | In progress | Processed | Processed on time (%) | In progress still on time (%) |
|---|---|---|---|---|---|
| Actives | 102 | 250 | 90 | 90.0% | 94.8% |
| Emergency permits (Item 22) | 18 | 15 | 15 | N/A | N/A |
| Permits (excluding emergency) | 155 | 265 | 130 | 90.0% | 85.3% |
| Pesticides | 180 | 387 | 209 | 92.3% | 87.3% |
| Veterinary medicines | 178 | 264 | 167 | 91.6% | 94.7% |
| Total | 633 | 1 181 | 611 | 91.3% | 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 | 11 | 12 | 12 | 25.0% |
| PAA Tier 2 | 38 | 50 | 29 | 27.6% |
| PAA Tier 3 | 1 | 3 | 3 | 0.0% |
| Total | 50 | 65 | 44 | 25.0% |
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| Types of regulatory decisions | Received | In progress | Processed | Issued | Refused | Withdrawn or Other |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) | 18 | 15 | 15 | 12 | 3 | 0 |
Technical assessment, notifiable variations, holders and nominated agents
| Types of regulatory decisions | Received | In progress | Processed | Processed on time (%) |
|---|---|---|---|---|
| Items 8L, 8M, 8P | 212 | 8 | 338 | 100.0% |
| Technical assessment (Item 25) | 5 | 11 | 3 | 100.0% |
| Notifiable variations | 162 | 0 | 162 | 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 | 119 | 13 | 163 | 94.5% |
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 | 92 | 21 | 89 | 86 | 61.8% |
| Certificates | 280 | 23 | 315 | 312 | 58.1% |