1. Summary of activities related to regulatory decisions – December quarter 2022
| Types of regulatory decisions | Received | In progress | Processed |
|---|---|---|---|
| Pre-application assistance | 55 | 48 | 86 |
| Product registration – pesticides | 201 | 378 | 317 |
| Product registration – veterinary medicines | 240 | 240 | 322 |
| Permits (exc emergency) | 122 | 155 | 134 |
| Emergency permits (Item 22) | 22 | 3 | 22 |
| Actives | 68 | 193 | 93 |
| Items 8L, 8M, 8P | 82 | 2 | 166 |
| Technical assessment (Item 25) | 2 | 11 | 6 |
| Notifiable variations | 111 | 0 | 111 |
| Import consents | 133 | 1 | 145 |
| Certificates of export | 50 | 32 | 61 |
| Totals | 1 086 | 1 063 | 1 463 |
See description of application types.
Applications processed
| Type | Received | In progress | Processed | Processed on time (%) | In progress still on time (%) |
|---|---|---|---|---|---|
| Actives | 68 | 193 | 93 | 98.90% | 97.40% |
| Emergency permits (Item 22) | 22 | 3 | 22 | N/A | N/A |
| Permits (excluding emergency) | 122 | 155 | 134 | 97.80% | 96.10% |
| Pesticides | 201 | 378 | 317 | 94.60% | 95.00% |
| Veterinary medicines | 240 | 240 | 322 | 99.70% | 97.50% |
| Totals | 653 | 969 | 888 | 97.50% | 96.30% |
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).
2. 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 | 12 | 3 | 22 | 31.80% |
| PAA Tier 2 | 38 | 38 | 61 | 65.60% |
| PAA Tier 3 | 5 | 7 | 3 | 0.00% |
| Total | 55 | 48 | 86 | 54.70% |
3. 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. In this reporting period, the APVMA issued 14 emergency permits, taking an average of 21 days, with a range of 3 to 95 days.
| Types of regulatory decisions | Received | In progress | Processed | Issued | Refused | Withdrawn or other |
|---|---|---|---|---|---|---|
| Emergency permits (Item 22) |
22 |
3 | 22 | 14 | 0 | 8 |
4. Technical assessment, notifiable variations, holders and nominated agents
| Types of regulatory decisions | Received | In progress | Processed | Processed on time (%) |
|---|---|---|---|---|
| Items 8L, 8M, 8P | 82 | 2 | 166 | 100.00% |
| Technical assessment (Item 25) | 2 | 11 | 6 | 100.00% |
| Notifiable variations | 111 | 0 | 111 | 100.00% |
5. 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 | 133 | 1 | 145 | 97.90% |
6. Certificates of export
Before accepting exports of a chemical product from Australia, many countries require 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 days. Please note that an application may request multiple certificates.
| ⠀ | Received | In progress | Processed | Issued | Processed on time (%) |
|---|---|---|---|---|---|
| Applications | 50 | 32 | 61 | 57 | 45.90% |
| Certificate of export | 85 | 45 | 102 | 91 | 46.1% |