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AgVetLink July 2003 - Special Issue for Registrants

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Registrant obligations for imported products

We would remind all registrants that the product imported must be exactly the same as the product registered or exempted from registration in New Zealand. This means that it must be fully compliant with labelling and pack sizes that have been approved. Recent activity has shown non-compliances in this area.

Manufacturing

If you are importing a registered product that requires overlabelling, you should be aware that this constitutes a manufacturing process step and that all manufacturing sites must be listed in the manufacturing specifications for a registered trade name product.

It is a breach of the ACVM Act to import registered or exempted products that are not correctly labelled. In the near future we expect to introduce a level of physical checking at the border to ensure compliance.

Manufacture, in relation to any agricultural compound, means to make up, prepare, produce, or process the agricultural compound; and includes the packing (and labelling) of an agricultural compound in a container for the purposes of sale. Therefore any site that carries out any of these activities (or any subdivision of these activities such as quality testing) must be listed in the manufacturing specification.

Any changes in manufacturers or manufacturing sites must be notified to the ACVM Group so the approved manufacturing specification can be updated. If you are concerned that a manufacturing site may not have been included in the manufacturing specifications that were provided with the application to register a product, you should notify the ACVM Group.

Modifying the manufacturing specification on the product file presumes that:

• its absence from the manufacturing specifications was an historical oversight; and
• the site is actually an approved manufacturing site.

If the site is a new site, then a registrant must lodge an application to vary a registration to get the new site properly approved. Failure to provide com-prehensive manufacturing speci-fications may jeopardise the continued registration of a product.

Pack sizes

Under the ACVM Group policy covering additional pack size approval, the ACVM Group will approve a range of pack sizes at initial registration, provided the appropriate data and information are supplied. From that point, all pack sizes with risk profiles that fall within the assessed range (such as the same packaging material) will be considered approved.

For existing products, a normal C3 application can be made to approve a range of pack sizes with referencing to data already on file, or via the provision of additional information. In either case, the ACVM Group will require notification of the actual pack sizes being marketed in the form of an official letter, which must be provided each time a new pack in the approved range is introduced to the market.

In addition, any subsequent application requiring a product data sheet to be submitted must state the marketed pack sizes as well as the approved range. Labels for additional packs will not require approval provided the content does not differ from that approved.

For new packs falling outside of the approved risk profiles, new data and a C3 application will be required.

Please advise us of any changes to your contact details.

 

Public information about applications and registered products

Applicants and registrants are reminded that ‘Part A’ of the product data sheet (PDS) is public information.

For applications that need gazetting this information is supplied in response to any queries. We are hoping in the near future to put the information that is gazetted and the additional public information on the website so that interested and affected people have easier access to it.

Where there are queries about already registered products, Part A of the PDS will be made available.