Quality Assurance and Compliance

The Quality Assurance and Compliance section is responsible for a number of APVMA programs aimed at:

Assuring (give confidence in) the quality of veterinary chemical products manufactured and / or supplied in Australia;

Ensuring that manufacturers, importers and suppliers of agricultural and veterinary chemicals are aware of and exercise their responsibilities with regard to the compliance requirements of Australia's agricultural and veterinary chemicals legislation; and

Facilitating exports through international harmonisation and attestation of GMP compliance.

The Section has two groups:

Quality Assurance Group

The Quality Assurance group, is responsible for quality assurance programs that focus on the quality of veterinary products at pre-registration, during manufacture and post-registration. The programs are designed to ensure that quality is built into veterinary chemical products through adherence to contemporary manufacturing standards and assist manufacturers and registrants to responsibly manage and ultimately improve the quality of veterinary chemical products available to the Australian consumer. The programs include:

Adverse Experience Reporting

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Adverse Experience Reporting Program for Veterinary Chemical Products (AERP Vet) . A pharmacovigilance program that facilitates responsible management of veterinary chemical products throughout their lifecycle.

Adverse Experience Reporting Program for Agricultural Chemicals (AERP Ag) . A quality assurance program established by the APVMA to facilitate responsible management of agricultural chemical products throughout their lifecycle.

Manufacturers' Licensing Scheme (MLS) A quality assurance program based on Good Manufacturing Practice (GMP) for Australian based veterinary chemical product manufacturers.

Overseas GMP Scheme: Recognition of Overseas Based Manufacturers of Veterinary Chemical Products. A program for assuring the Good Manufacturing Practice (GMP) compliance of overseas veterinary chemical product manufacturers.

Mutual Recognition Agreements (MRAs) Provide for facilitation of exports of veterinary chemical products through international harmonization and attestation of GMP compliance.

Certification for Export Purposes Provide for facilitation of exports of veterinary chemicals through attestation of GMP compliance.

Compliance Group

The Compliance group, is responsible for programs and initiatives aimed at ensuring that manufacturers, importers and suppliers of agricultural and veterinary chemicals are aware of and exercise their responsibilities with regard to the compliance requirements of Australia's agricultural and veterinary chemicals legislation. Programs and initiatives include:

Reporting Non-compliant Agricultural or Veterinary Chemicals or Advertising. Provides for reporting and dealing with reports of agricultural and veterinary chemicals or advertising that may not be compliant with the requirements of Australia's agricultural and veterinary chemicals legislation.

Advice to advertisers and publishers

Consent to Import Unapproved Active Constituents or Unregistered Agricultural or Veterinary Chemical Products Provides for importation of unapproved active constituents or unregistered agricultural or veterinary chemical products for special but limited circumstances such as research, use under an APVMA Permit etc.

Supply and Sale of Hormonal Growth Promotants (HGPs) A program for accounting for supply and use of HGPs and thereby ensuring supply of HGP free meat and meat products to the European Union.

Recalls Provide for and facilitate removal of non-compliant agricultural and veterinary chemicals, and relevant advertising and promotional material from the Australian marketplace.