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Certification under the Agricultural Compounds and Veterinary Medicines Legislation

November 2008

We only certify what we can verify.*

Purpose of certification

The purpose of certification is to verify and certify information as requested by the registrant/authorised New Zealand agent of a trade name product. Certificates are also issued to the proprietor of agricultural compounds exempt from registration if the relevant conditions in the ACVM Regulations 2001 are complied with (as evidenced by a current Class Determination).

Certificates listed below are issued by the ACVM Group on behalf of the Director General under section 35A of the ACVM Act. The current fee structure for certification is on the website.

Standard Certificate of Free Sale

Certifies the following information:

• Registrant/distributor

• Product trade name

• Registration number, if applicable

• The product:

- is registered for manufacture and/or use in New Zealand or exempt from registration as it meets the relevant conditions in the ACVM Regulations 2001

- can be lawfully and freely sold in New Zealand by the registrant/distributor in accordance with the conditions on the certificate of registration under the ACVM Act or is exempt from registration under the ACVM Act.

For veterinary medicines only

• Whether the New Zealand manufacturing premises are authorised

• The plant manufacturing the product is subject to adequate inspection intervals and follows the ACVM Standard and Guideline for Good Manufacturing Practice for the manufacture and quality control of pharmaceutical preparations destined for sale or distribution in New Zealand or export.

Certificate of Origin

Certifies the following information:

• Trade name and form

• Composition, if applicable

• Name and address of manufacturing plant, if applicable

• Premises authorisation number, if applicable

For veterinary medicines only

• The pharmaceutical veterinary antigen is a component of products manufactured in New Zealand, if applicable

• The New Zealand premises manufacturing the product is subject to adequate inspection intervals and follows the ACVM Standard and Guideline for Good Manufacturing Practice for the manufacture and quality control of pharmaceutical preparations destined for sale or distribution in New Zealand or export.

Certificate of Good Manufacturing Practice

Certifies the following information:

• Whether a New Zealand company is authorised to manufacture veterinary medicines in New Zealand

• That, from the knowledge gained during inspections of this manufacturer, it is considered that the company complies with the ACVM Standard and Guideline for Good Manufacturing Practice.

* Certification

The ACVM Group will certify only when it can verify the content of the certificate and only for products: • that are within the scope of the ACVM legislation, and • that are trade name products that are registered or exempt from registration as evidenced by a Class Determination, and • in accordance with NZFSA certification policies.

Further information:

If you require further information regarding certification, contact us.