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Conditions on registered agricultural compounds

In developing the ACVM Regulations  2001 the ACVM Group has produced   schedules of conditions for the  following kinds of agricultural   compounds:

• prescription animal remedies in classes I, II, and III;
• over-the-counter veterinary medicines; and
• over-the-counter plant products.

The schedules contain generic conditions and refer to the current approval in which the product-specific conditions are listed along with the product specifications that have been approved. The conditions are as follows.

Class III prescription animal remedy

The product must be manufactured in accordance with the ACVM Standard for Good Manufacturing Practice and to the chemistry and manufacturing specifications provided by the registrant and approved as part of the registration.

In addition to any labelling requirements specified in the current approval, labelling must comply with the ACVM Standard and Guidelines for  Labelling.

The product must be sold or imported only according to the current approval.

The product must not be sold to any person other than a veterinarian or dealer.

The product must not be administered except following a veterinary consultation.

The product must be administered to an animal only by a veterinarian.

The product may be used at the discretion of a registered veterinarian:

• when acting in accordance with any applicable code of practice approved under section 28 of the ACVM Act; and
• on animals under the direct care of that veterinarian,

unless that use is expressly prohibited in the current approval.

The product has been assessed only for residues and safety for use in the species, type, age, and gender of animal and manner specified in the current approval.

There are no assurances or warranties made by the registrant as to the effectiveness or appropriateness of the product when used in a manner not recommended by the registrant.

Class II prescription animal remedy

The product must be manufactured in accordance with the ACVM Standard for Good Manufacturing Practice and to the chemistry and manufacturing specifications provided by the registrant and approved as part of the registration.

In addition to any labelling requirements specified in the current approval, labelling must comply with the ACVM Standard and Guidelines for Labelling.

The product must be sold or imported only according to the current approval.

The product must not be sold to any person other than a veterinarian or dealer.

The product must not be administered except following a veterinary consultation.

The product must be administered to an animal only by a veterinarian, or in the presence and under the control of a veterinarian.

The product has been assessed only for residues and safety for use in the species, type, age, and gender of animal and manner specified in the current approval.

The product may be used at the discretion of a registered veterinarian:

• when acting in accordance with any applicable code of practice approved under section 28 of the ACVM Act; and
• on animals under the direct care of that veterinarian,

unless that use is expressly prohibited in the current approval.

There are no assurances or warranties made by the registrant as to the effectiveness or appropriateness of the product when used in a manner not recommended by the registrant.

Class I prescription animal remedy

The product must be manufactured in accordance with the ACVM Standard for Good Manufacturing Practice and to the chemistry and manufacturing specifications provided by the registrant and approved as part of the registration.

In addition to any labelling requirements specified in the currently approval, labelling must comply with the ACVM Standard and Guidelines for Labelling.

The product must be sold or imported only according to the current approval.

The product must not be sold to any person other than a veterinarian or dealer, or otherwise than pursuant to the prescription of a veterinarian.

The product must not be administered, or prescribed or dispensed except following a veterinary consultation.

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