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AgVetLink December 2002

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Plants not to be included in oral and topical preparations

Oral and topical preparations for uses associated with animals are regulated by the ACVM Group. These products are exempt from registration when they are prepared from either any part of a plant or an unrefined extract from a plant, except where the plant is included in Schedule 6 of the ACVM Regulations 2001. The conditions of this exemption state that where these products are used as a veterinary medicine the product label must identify the compound as an herbal preparation. Additionally, the label must include a statement that if the preparation fails to alleviate the condition being treated the user should seek veterinary advice.

The ACVM Group recognises that in certain situations a plant, or plant extract, may have toxic properties. Schedule 6 of the ACVM Regulations lists plants not to be included in oral and topical preparations if the preparation is to be exempt from registration. The list enables conditions to be placed on products containing plants that are known to be toxic, or produce a pharmacological effect, through the conditions of the product registration.

To have a plant included on this list an application expressing the general concern surrounding the safety of the plant must be made to the ACVM Group. (The consequence of including a plant in this schedule is that it may not be used in products without them first being registered.)

The Group will consider the application and prepare a public notice of intent, inviting public comment on the proposal (if it is agreed to continue to process the application). A similar mechanism will be used to remove plants from the list – an application to have a plant removed must be accompanied by data supporting the fact that a plant has a history of safe use. The final decision to include or remove a plant from the list will be made by the ACVM Group.

To ensure that all relevant parties are informed of proposed modifications to the list and are invited to comment, the ACVM Group would like to create a network of relevant parties who will be sent public discussion documents. If you are interested, or know of any party who may be interested, please contact Nicola Reeves, Assessor (Technical Standards – Toxicology) 
Phone: 04 463 2535 or 
Email: nicola.reeves@nzsfsa.govt.nz

Agents and consultants

The use of an 'agent' for products registered under the Pesticides Act or licensed under the Animal Remedies Act has a different meaning to the term 'New Zealand Agent' under the ACVM Act.

Under the ACVM Act anyone can register a product in New Zealand. Under s24 (b) they must also specify who their New Zealand Agent is. This means that if an overseas company is making an application, communication for the registration process is between the ACVM Group and that company.

The ACVM Group considers that the New Zealand Agent has some legal obligations. For instance, should any adverse event occur with the product in New Zealand, the New Zealand Agent is contacted and has responsibility for taking the appropriate actions. The New Zealand Agent is also entered on the public register (this detail is available on the website).

On the other hand, a 'consultant' is a person who assists the applicant in compiling and/or making the application. A consultant can act on behalf of the applicant throughout the process of registration. They are not necessarily the New Zealand agent and do not appear on the public register on the website unless they are the Agent as well.

We advise that:

• all applicants/registrants need to ensure that their New Zealand Agent for a product is clearly identified on the Registration and Product Data Sheet (PDS);
  and
• the New Zealand Agent details are listed on the public register.

Annual fees

Veterinary medicine annual fee invoices were sent out in September 2002. If payment of these fees is not received by 24 January 2003 registrants will be contacted and advised of the additional steps (likely to be suspension or revocation of existing registrations) that will be taken.

Plant compounds annual fee invoices have been delayed. These should be posted by the end of December 2002 and will be due for payment before March 2003. If you have any queries, please contact Sarah Smyth, Coordinator (Business Services) 
Phone: 04 463 2553 or 
Email: sarah.smyth@nzfsa.govt.nz