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Draft Policy on Toxicology Data Requirements for Medicines Registered Under the Act 1981

There has been a move with the ACVM Act policy development to clearly relate the data required in an application to the risks that a particular product poses. Several applicants have suggested that where a product has already been assessed under the Medicines Act 1981 (i.e. given consent under sections 20, 21 and 22) and the product is not going into the food chain, there is an opportunity to speed the licensing process, and to reduce costs to applicants while still covering the Animal Remedies Board considerations for the safety of the product.

A suggested policy will be placed before the Animal Remedies Board when it meets in October. The suggestion is that, where an animal remedy licence application is for a product that contains the same active ingredient as a medicine that has already been given consent to be sold under the Medicines Act 1981, the requirement for toxicology and ecotoxicology data to support the application might be waived, provided the applicant can confirm:

• the product is not to be used in food-producing animals;
• the toxicology data on the active ingredient is not subject to data protection under the Animal Remedies Act 1967;
• the active ingredient is not under data protection under the Medicines Act 1981;
• target animal safety data is provided to the level required in the standard;
• the National Poisons Information Centre has been notified of the product; and
• the product label will include statements as detailed by the ACVM Group.

All other established Board policies applicable to the application remain in force.

Any comments or suggestions should be directed to:

John Reeve
National Manager Residues & Toxicology
ACVM Group
Ministry of Agriculture and Forestry
Post Office Box 2526, Wellington
Email: reevej@maf.govt.nz