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Notification of manufacturers

There has been some confusion concerning manufacturers* who are required to be advised to the ACVM Group. The following explains what information is legally required to be provided after products have been transferred under the Agricultural Compounds and Veterinary Medicines (ACVM) Act.

Legislation

The Animal Remedies (AR) Act 1967 specifies that all manufacturing sites must be included on the (product) licence and on the Register of Licensed Products. The ACVM Act specifies that the registrant must be on the (product) registration certificate, but all manufacturing sites must be on the Register of Registered Products.

Requirements under the Animal Remedies Act 1967 (and the Transitional Period)

Two types of 'licences' are provided to stakeholders. One is a licence to manufacture or import an animal remedy under the Animal Remedies Act section 19. This has generally become known as the 'product licence'. The second is certification that a manufacturer is in compliance with Good Manufacturing Practice (GMP) requirements.

Under the AR Act section 19 (2)(b) all the details relating to the preparation of the licensed product are required to be supplied to the ACVM Group, including all subcontracting manufacturers. Section 21 (7)(d) of the AR Act is explicit in requiring: The address of every place where the animal remedy is being or is to be manufactured.

The AR Act section 31 requires the Registrar to keep a register of (product) licences, and to include under section 31 (2)(b): The name and principal business address of the licensee and the address of every place where the manufacture or, as the case may be, importation of the remedy is carried on by the licensee.

Therefore, since products are currently licensed as animal remedies, and since we are still operating within the transitional period, the ACVM Group is legally required to state the address of every place where the animal remedy is being manufactured on the (product) licence.

Requirements under the ACVM Act

The position will be different under the ACVM Act. Animal remedies and pesticides will be transferred under the ACVM Act as agricultural compounds or veterinary medicines.

Under the ACVM Act section 24, the Director-General must keep a register of all trade name products (agricul-tural compounds) registered under section 21 or section 27. Under section 24 (2)(j), this register must specify: The address of every place of business where the registered trade name product is being or is to be manufactured …

Under the ACVM Act section 25, the Director-General must issue a certificate of registration of an agricultural compound, which must specify:

• s. 24(a), one trade name
• s. 24(b), name and address of registrant
• s. 24(d), application number and date granted
• s.24(e), whether product is registered under s.21 or s.27
• s. 24(f), conditions on any registration
• s. 24(i), registration expiry date and, in addition under section 24(k), may specify such other matters as the Director-General thinks fit.

Therefore, after products are transferred under the ACVM Act there is no legal requirement for the ACVM Group to place names of manufacturers or subcontracting manufacturers on the registration certificate (unless a good regulatory or compliance reason for requiring the inclusion becomes apparent).

However, there is a legal requirement for MAF to include all manufacturing sites concerned with a product on the register, and the register is a public document in whatever form it appears.

Considering the above requirements, if there should be additional manufacturers involved with the manufacturing, packing or testing of products that a licensee or registrant has not notified to the ACVM Group, please ensure that all manufacturers are included when you update your registrations (for the transfer process).

*A manufacturer is any person or organisation that manufactures** an agricultural compound. Where the process of manufacturing an agricultural compound or veterinary medicine is carried out on different sites or by contractor manufacturers on behalf of the registrant, all such contributors shall be recorded as manufacturers of the product in the register.

** Manufacture, in relation to an agricultural compound or a veterinary medicine, includes any of the following activities:

• Acquiring materials, making up, preparing, producing or processing and assessing the trade name product for release for sale, and
• Packing an agricultural compound in a container, or labelling or re-labelling for the purposes of sale.