| Types of regulatory decisions | Received | In progress | Processed |
|---|
| Pre-application assistance | 103 | 66 | 81 |
| Product registration – pesticides | 240 | 416 | 202 |
| Product registration – veterinary medicines | 181 | 249 | 204 |
| Permits (excluding emergency) | 114 | 186 | 139 |
| Emergency permits (Item 22) | 12 | 5 | 17 |
| Actives | 107 | 279 | 66 |
| Items 8L, 8M, 8P | 71 | 1 | 73 |
| Technical assessment (Item 25) | 7 | 13 | 5 |
| Notifiable variations | 134 | 2 | 132 |
| Import consents | 179 | 14 | 181 |
| Certificate of export | 127 | 45 | 115 |
| Total | 1 275 | 1 276 | 1 215 |
See description of application types.
Applications processed
| Type | Received | In progress | Processed | Processed on time (%) | In progress still on time (%) |
|---|
| Actives | 107 | 279 | 66 | 100.0% | 95.0% |
| Emergency permits (Item 22) | 12 | 5 | 17 | N/A | N/A |
| Permits (excluding emergency) | 114 | 186 | 139 | 97.8% | 93.0% |
| Pesticides | 240 | 416 | 202 | 95.0% | 96.2% |
| Veterinary medicines | 181 | 249 | 204 | 100.0% | 96.0% |
| Total | 654 | 1 135 | 628 | 97.9% | 95.3% |
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 | 15 | 7 | 17 | 35.3% |
| PAA Tier 2 | 41 | 51 | 20 | 35.0% |
| PAA Tier 3 | 47 | 8 | 44 | 100.0% |
| Total | 103 | 66 | 81 | 70.4% |
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| Types of regulatory decisions | Received | In progress | Processed | Issued | Refused | Withdrawn or Other |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) | 12 | 5 | 17 | 10 | 0 | 7 |
Technical assessment, notifiable variations, holders and nominated agents
| Types of regulatory decisions | Received | In progress | Processed | Processed on time (%) |
|---|
| Items 8L, 8M, 8P | 71 | 1 | 73 | 100.0% |
| Technical assessment (Item 25) | 7 | 13 | 5 | 100.0% |
| Notifiable variations | 134 | 2 | 132 | 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 | 179 | 14 | 181 | 96.1% |
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 | 127 | 45 | 115 | 113 | 77.4% |
| Certificates | 268 | 117 | 191 | 189 | 85.9% |
