Elsewhere on DAFF
Veterinary Products such as therapeutics and medicines
Veterinary products such as therapeutics, medicines, topical washes and semen extenders
The requirements outlined below apply to commercial and non-commercial (i.e. personal use) consignments of imported veterinary products.
Domestic pet owners should review the information below thoroughly before ordering veterinary products from overseas to ensure the strict requirements and charges associated with importation of veterinary products can be met.
General requirements
Imported veterinary products manufactured using biological material i.e. animal, plant, microbial or fungal derived material, represent a potential pathway for the introduction of diseases or pests. Importers wishing to bring these goods into Australia are required to apply for an AQIS import permit before they do so (see below for exemptions relating to AQIS approved excipients). AQIS will assess your import permit application when you submit a completed permit application form together with supporting documents. You should submit your application to the AQIS Biological Imports Program.
Fees
AQIS issues import permits on a fee for service basis. Veterinary products are classified as Category 5 commodities for assessment purposes.
AQIS approved excipients
Pharmaceutical excipients are highly processed substances that are components of therapeutic products. Veterinary products that are manufactured using only AQIS approved excipients are exempt from permit requirements however importers need to check the ICON case for Veterinary therapeutics and medicines to ensure they can satisfy documentation requirements. The following substance groups are considered AQIS approved excipients:
- Alcohols
- Amino acids
- Essences
- Esters
- Wool fats eg Lanolin
- Fragrances
- Water
- Pectins
- Plant acids
- Plant extracts
- Plant gums
- Plant juices
- Plant oils
- Plant waxes
- Resins
- Starches
- Sugars
- Tinctures
- Vinegars
- Vitamins
Supporting documentation
So that AQIS may effectively and efficiently complete an assessment of permit applications, applicants are required to provide supporting technical information specific to the product being imported. The technical information outlined below will allow AQIS to undertake a full assessment in the majority of cases. This information is required for all new applications including those submitted for reassessment of an existing permit. If importers are sourcing the product from multiple manufacturers, documentation specific to each manufacturer will be required and a separate assessment fee will be charged for each manufacturer.
Supporting information should be dated as current, i.e. no older than 6 months, and provided on manufacturer's letterhead signed by a suitable representative of the manufacturing company e.g. Quality Assurance or Regulatory Affairs staff member.
1. Full list of ingredients present in the product
This must include all animal, plant, microbial, fungal and synthetic ingredients present in the final product. Manufacturers' documents must specify the origin of each ingredient. If any ingredients have been manufactured using fermentation the following will also need to be provided:
(a) a full list of culture media ingredients used
(b) the genus and species of the microorganism(s) used.
2. Species/tissue/country of origin
For all animal derived ingredients, manufacturers' documents must specify the species, tissue and country of origin. Where manufacturers source ingredients from a supplier a Quality Assurance document (e.g. Certificate of Analysis) from the supplier should be supplied to verify this information.
3. Flow chart outlining the production process
A flow chart must summarise all steps in the production process. The flowchart should reference all processing steps which may be considered hostile to bacteria/viruses, e.g. sterilisation or other moist heat processes. Please include details regarding sterilisation temperatures and times applied, addition of chemicals, purification, fermentation, and any testing undertaken.
4. Plant derived ingredients
Information will need to be provided to AQIS to verify that the quarantine risk associated with plant derived ingredients has been addressed. The information provided must verify that:
(a) the final product contains no plant derived ingredients that might be considered viable and capable of germination (e.g. seeds)
(b) all plant derived ingredients have been subject to processing steps which remove the risk of contamination with plant pests and diseases.
5. Manufacture under a code of Good Manufacturing Practice (GMP) or similar Quality System
Applicants will need to source documents from overseas manufacturers which confirm that the veterinary product was manufactured in a facility that complied with an appropriate code of GMP (or similar Quality Management System). AQIS may require further information to confirm the following:
a) the quality control procedures are applied during appropriate stages of production
b) procedures in place to minimise the risk of cross contamination during production (e.g. testing and quality control checks for cross contamination).
6. Australian Pesticides and Veterinary Medicines Authority (APVMA) registration
Many veterinary products being imported into Australia will also be subject to the regulatory requirements of the APVMA. Although not essential for the assessment process, it may assist AQIS in assessing the product(s) if those applying for AQIS import permits provide a copy of the APVMA registration certificate and a copy of the APVMA approved label for the product.
N.B. Importers of veterinary products should contact the APVMA if at all unsure as to their obligations under the Agricultural and Veterinary Chemicals Act 1994.
Commercial in confidence issues
All information provided to AQIS remains strictly commercial in confidence. With this in mind manufacturers may wish to provide supporting documentation directly to AQIS once the application for import permit has been lodged.
Further information
For further information on the AQIS import permit assessment process for veterinary products please contact the AQIS Biological Imports Program:
Email AQIS Biological Imports Program
Phone: 02 6272 4578 (Monday to Friday, 9-11am, 2-4pm only)
Fax: 02 6249 1798
08 Jan 2010