The data guidelines provide applicants with guidance on what data and information to prepare and provide to support their application.
Applications need to address a range of criteria such as safety, trade and efficacy. For the APVMA to grant…
Where recognised evidence of an overseas manufacturing site's Good Manufacturing Practice (GMP) compliance is not available, an overseas manufacturer may choose to undergo an audit by an Australian Pesticides and Veterinary Medicines Authority (…
A manufacturing licence holder is required to undergo regular audits of the manufacturing site in accordance with the Good Manufacturing Practice (GMP) audit procedure to ensure continued compliance with the Australian Pesticides and…
The Australian Pesticides and Veterinary Medicines Authority (APVMA) can issue short-term permits for the manufacture of veterinary chemical products in Australia.
Permit applications are only considered under exceptional circumstances.The…
To make changes to details on a manufacturing licence – or to its conditions – holders must apply to the Australian Pesticides and Veterinary Medicines Authority (APVMA) for a licence variation.
Changes can include:
a change to the company…Licences to manufacture veterinary chemical products in Australia are issued with specific licence conditions.
This means licence holders are required to comply with all conditions contained within the Agvet Code Regulations or listed on…
- <p>An outline of the legislative basis and systems used for our role in manufacturing quality and licensing.</p>
Manufacturers of veterinary chemical products have ongoing compliance responsibilities under the Agvet Code.
Specific responsibilities depend on the steps of manufacture a person is responsible for and whether their site of…
- Enforced self-regulation
Licensed veterinary chemical manufacturing facilities are audited under what can be described as ‘enforced self-regulation’.
Manufacturers are responsible for ensuring they have an effective quality management system.… Overseas veterinary chemical product manufacturers are not licensed by the Australian Pesticides and Veterinary Medicines Authority (APVMA). In order to supply an intermediate or finished product to Australia, they need to comply with standards…