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Summary of activities related to regulatory decisions – December quarter 2023
| Types of regulatory decisions | Received | In progress | Processed |
|---|---|---|---|
| Pre-application assistance | 47 | 58 | 55 |
| Product registration – pesticides | 207 | 389 | 244 |
| Product registration – veterinary medicines | 202 | 232 | 218 |
| Permits (excluding emergency) | 120 | 191 | 115 |
| Emergency permits (Item 22) | 21 | 11 | 15 |
| Actives | 102 | 266 | 121 |
| Items 8L, 8M, 8P | 32 | 0 | 33 |
| Technical assessment (Item 25) | 2 | 9 | 7 |
| Notifiable variations | 172 | 1 | 171 |
| Import consents | 170 | 3 | 182 |
| Certificate of export | 65 | 40 | 70 |
| Interchangeable constituent determination | 1 | 2 | 0 |
| Total | 1 141 | 1 202 | 1 231 |
See description of application types.
Applications processed
| Type | Received | In progress | Processed | Processed on time (%) | In progress still on time (%) |
|---|---|---|---|---|---|
| Actives | 102 | 266 | 121 | 93.4% | 94.7% |
| Emergency permits (Item 22) | 21 | 11 | 15 | N/A | N/A |
| Permits (excluding emergency) | 120 | 191 | 115 | 87.8% | 89.0% |
| Pesticides | 207 | 389 | 244 | 94.7% | 92.3% |
| Veterinary medicines | 202 | 232 | 218 | 96.8% | 93.5% |
| Total | 652 | 1 089 | 713 | 94.0% | 92.6% |
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 | 7 | 11 | 36.4% |
| PAA Tier 2 | 32 | 45 | 38 | 28.9% |
| PAA Tier 3 | 4 | 6 | 6 | 66.7% |
| Total | 47 | 58 | 55 | 34.5% |
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| Types of regulatory decisions | Received | In progress | Processed | Issued | Refused | Withdrawn or other |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 | 11 | 15 | 15 | 0 | 0 |
Technical assessment, notifiable variations, holders and nominated agents
| Types of regulatory decisions | Received | In progress | Processed | Processed on time (%) |
|---|---|---|---|---|
| Items 8L, 8M, 8P | 32 | 0 | 33 | 100.0% |
| Technical assessment (Item 25) | 2 | 9 | 7 | 85.7% |
| Notifiable variations | 172 | 1 | 171 | 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 | 170 | 3 | 182 | 95.1% |
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 | 65 | 40 | 70 | 62 | 55.7% |
| Certificates | 117 | 41 | 193 | 185 | 71.5% |