This content is current only at the time of printing. This document was printed on 6 December 2016. A current copy is located at http://apvma.gov.au/node/374
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Consent to import chemical products
1. What is an Import Consent?
Section 69B of the Agricultural and Veterinary Chemicals (Administration) Act 1992 prevents the importation of unregistered agricultural or veterinary chemicals, or unapproved active constituents. Import Consents are issued to allow importation in limited circumstances where it would otherwise be an offence under this law.
Full details of Section 69B can be found here.
3. What does ‘imported’ mean?
Once goods have landed in Australia or have been brought within Australia’s borders (airport or port), we consider them as ‘imported’.
4. Making an application for an Import Consent
The timeframe for processing an Import Consent application is 14 days. Applicants should take this into account before submitting an application to allow enough time for the Consent to be processed before the product arrives in Australia.
Within 14 days of submission, all applications will be acknowledged by either:
- issuance of an Import Consent
- a request for more information or
- refusal of an application.
Note: If you submit an application for an import that will occur within the 14-day timeframe, we are not able to prioritise your application.
5. Assessing your application
5.1. General considerations
When assessing an application, the APVMA will consider:
- the identity and composition of the product or active constituent
- the purpose of the import
- the quantity
- the proposed supply or use
- the proposed date of import – we cannot issue a Consent retrospectively
- any other relevant information provided with the application
- requirements of other agencies such as the Department of Health or Australian Customs
- relevant international conventions or agreements adopted by the Australian Government
- whether other relevant applications have been lodged with the APVMA
- whether current APVMA approval applies to the proposed use
- any potential risks for humans, animals, the environment, industry or trade
- that no further supply other than that approved by the APVMA will occur.
5.2. Considerations and criteria for agricultural chemical products
An Import Consent may only be issued for an agricultural chemical product or unapproved active constituent if there is a current APVMA permit in place for its use. See Permits section for more information.
An application for an Import Consent can be made at the same time as the permit application, during evaluation or after approval of the permit, however an Import Consent will not be approved until a permit has been issued.
The APVMA will not issue an Import Consent for use under a Permit unless it is satisfied that the conditions of the permit will be complied with.
Application for an Import Consent - where the product will be dealt with under an APVMA Permit, including small scale trial permit no. 7250
5.3. Considerations and criteria for veterinary medicines
The APVMA will only consider Import Consent applications lodged by a registered veterinarian or a person acting under the direction of a registered veterinarian.
The medicine must be for use on an animal that is under the direct care of the registered veterinarian and its use must comply with any local state or territory laws.
The APVMA will not issue a Consent where there is a similar or similar looking Australian registered product or where an Australian registered product will do the same thing as the proposed imported product.
Application for an Import Consent - where the product will be imported by a registered veterinarian for use under prescription or written direction.
5.4. Considerations and criteria for miscellaneous imports
The APVMA may issue an Import Consent for products where registration approval is expected and is close to finalisation or, for products intended for promotions or special events, such as trade shows.
Miscellaneous Import Consents are issued with additional conditions.
Application for an Import Consent - where the product will be dealt with under restricted conditions requiring undertakings, including pending registration or promotions and events.
6. Import Consent conditions
6.1. When issuing a Consent, the APVMA
- will allow a validity period of two to three weeks either side of the estimated time of arrival
- will make allowances for multiple shipments only if approved under a current APVMA Permit
- cannot issue a Consent covering multiple imports – each substance must have its own Consent
- may apply additional conditions that include
- warehousing and/or transportation conditions
- a ‘not supply’ notice or similar restriction
- destruction or re-exportation conditions
- subsequent publication in the APVMA Gazette.
The APVMA cannot issue a single Consent covering multiple imports – each product must have its own Consent.
The APVMA will issue a Consent that outlines who is the user, quantities, duration and conditions.
7. Can a Consent or an application be varied?
If you become aware that an Import Consent is not needed or if any details or conditions have changed before it is issued, you may ask the APVMA to either amend or withdraw your application.
If any details or conditions of your import change or if the importation date fails to meet the validity period, you will need apply for a new Consent.
The APVMA will not issue an Import Consent if importation has already occurred.
8. Additional considerations
Importation of chemical substances to Australia is also subject to a range of other legislation and you may need approval from other agencies. These may include:
- Therapeutic Goods Administration
- Office of Chemical Safety
- Department of Environment
- Office of the Gene Technology Regulator
- Department of Agriculture and Water Resources
- Department of Foreign Affairs and Trade
- Department of Immigration and Border Protection
It is your responsibility to make sure your importation meets all relevant Australian laws.