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FYI: Workshop questions

The most frequently asked questions during the recent registration workshops were the following.

Could we please have acknowledgement of when our application is formally accepted into the ACVM registration system?

We have updated our notification letter to inform applicants of formal acceptance. This will be operational immediately.

What applications must be publicly notified?

Sections 13 and 14 of the ACVM Act 1997 state:
13. Notification of application to Minister and departments
(1) The Director-General must, upon receipt of an application, notify the nature and proposed use of the trade name product or the proposed variation of conditions to –

(a) The Minister; and

(b) The Environmental Risk Management Authority; and

(c) Those Departments listed in Schedule 1 of the State Sector Act 1988 that have notified the Director-General that they have an interest in applications made under this Act.

(2) The Director-General must supply further information to any person notified under this section, if requested to do so by that person, unless that information is protected in accordance with sections 73, 109, or 121.

14 Notification of application
(1) The Director-General must, upon receipt of an application, publish a notice in the Gazette and give such further notice of the application as the Director-General thinks fit having regard to the nature of the application and the persons likely to have an interest in the application.

(2) The notice must include –

(a) A statement that an application has been made to register a trade name product or to vary a condition on a registered trade name product; and

(b) A brief summary of the relevant information on the trade name product; and

(c) Information on the proposed use of the trade name product or the variation proposed to a condition on a registered trade name product; and

(d) A statement that any person may make a written submission; and

(e) A closing date for receipt of the submissions by the Director-General, being no later than 30 working days after the date of public notification; and

(f) The place where the application and the accompanying information, other than information protected in accordance with sections 73, 109, or 121, may be viewed and the address for service of the Director-General and the applicant.

Will ERMA NZ give data protection for a new active ingredient if the toxicology package is not submitted with the application to the ACVM Group? What is ERMA's stance on this?

It is the ACVM Group's understanding that the data protection provisions of the HSNO Act are relevant only if an application for registration of a trade name product containing a new active ingredient is first lodged under the ACVM Act with the ACVM Group.

Why do we have to complete an application form for the change in packaging when there are no additional risks existing?

This is currently being discussed within the ACVM Group and the policy outcome will be notified in the next AgVetlink.

Advertising

Several companies are using advertising material with claims that have not been approved. These companies have been contacted individually to come into compliance with governing legislation.

Please refer to the following advertising sections:

• ACVM Act 1997 – section 102
• Pesticides Act 1979 – section 40
• Animal Remedies Act 1967 – section 41.

These documents are available from our website: www.maf.govt.nz/acvm/. The ACVM Group recommends that companies understand these sections of the relevant legislation and ensure they are compliant. Copies of the ACVM Act 1997 and ACVM Regulations 2001 are available from the ACVM Group website and also from Bennetts Government Bookshop, Bowen House, corner Bowen St & Lambton Quay, phone 04 499 3433.