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Summary of activities related to regulatory decisions – September quarter 2024
| Types of regulatory decisions | Received | In progress | Processed |
|---|---|---|---|
| Pre-application assistance | 69 | 60 | 74 |
| Product registration – pesticides | 231 | 439 | 179 |
| Product registration – veterinary medicines | 157 | 267 | 154 |
| Permits (excluding emergency) | 154 | 262 | 157 |
| Emergency permits (Item 22) | 16 | 14 | 17 |
| Actives | 109 | 290 | 69 |
| Items 8L, 8M, 8P | 103 | 0 | 111 |
| Technical assessment (Item 25) | 2 | 10 | 3 |
| Notifiable variations | 183 | 11 | 172 |
| Import consents | 161 | 25 | 148 |
| Certificate of export | 100 | 19 | 102 |
| Interchangeable constituent determination | 0 | 0 | 0 |
| Total | 1 285 | 1 397 | 1 186 |
See description of application types.
Applications processed
| Type | Received | In progress | Processed | Processed on time (%) | In progress still on time (%) |
|---|---|---|---|---|---|
| Actives | 109 | 290 | 69 | 91.3% | 94.5% |
| Emergency permits (Item 22) | 16 | 14 | 17 | N/A | N/A |
| Permits (excluding emergency) | 154 | 262 | 157 | 87.9% | 83.2% |
| Pesticides | 231 | 439 | 179 | 88.8% | 86.3% |
| Veterinary medicines | 157 | 267 | 154 | 97.4% | 90.6% |
| Total | 667 | 1 272 | 576 | 91.2% | 88.5% |
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 | 14 | 14 | 12 | 0.0% |
| PAA Tier 2 | 53 | 44 | 59 | 55.9% |
| PAA Tier 3 | 2 | 2 | 3 | 33.3% |
| Total | 69 | 60 | 74 | 45.9% |
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| Types of regulatory decisions | Received | In progress | Processed | Issued | Refused | Withdrawn or Other |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) | 16 | 14 | 17 | 14 | 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 | 103 | 0 | 111 | 100.0% |
| Technical assessment (Item 25) | 2 | 10 | 3 | 66.7% |
| Notifiable variations | 183 | 11 | 172 | 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 | 161 | 25 | 148 | 93.2% |
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 | 100 | 19 | 102 | 100 | 81.4% |
| Certificates | 204 | 41 | 186 | 174 | 88.7% |