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AgVetLink December 2003 - Special Issue for Registrants

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Labelling requirements for ACVM updates

It appears that some registrants may not have applied to update their products to ACVM registrations yet mainly because of confusion over labelling requirements. From the workshops run recently with ERMA New Zealand and industry representatives, it appears that the need for submission of final printed ‘glossy’ labels in order to update a product may have been a cause for concern, especially to those registrants who do not yet know of any labelling requirements under the HSNO Act.

We would therefore like to remind registrants that we only approve label content as it relates to risks under the ACVM Act.

Final printed labels are no longer required by the ACVM Group to finalise an application (but they are still welcomed when available).

The documentation required to update a product to an ACVM registration is:

• a covering letter requesting the update and confirming that no other changes are being made;
• a Registration and Product Datasheet (the latest version should be downloaded from our website);
• three copies of the revised draft label including all labelling components (where there is more than one pack size, all can be listed on one copy of the label unless the text varies for each size).

No fee is required for a simple update; however, any changes we identify from the current approval will mean a variation application and will incur the normal fees.

Where a product has more than one pack size, they will all be updated simultaneously, though registrants need not update all sizes in the market place right away. If, however, there are changes to label content that are sufficiently important, we will require that all pack sizes in the market place be updated immediately. This will be worked through with applicants case by case.

We recommend that registrants note the labelling guide drafted by Agcarm that is currently available on their website (www.agcarm.co.nz). This guide translates both ACVM and HSNO requirements into useful label statements. We understand that it may be put to ERMA New Zealand and the ACVM Group for approval under the Acts at a future date. Further information is available in the November 2003 edition of the Agcarm newsletter.

 

ACVM updates: phase in requirements for stock-in-trade

The ACVM Group has been working with organisations (including ERMA New Zealand, Agcarm and ARPPA representatives, and other registrant companies) to minimise the cost to registrants and the time taken for updating registrations under the ACVM Act. Part of the process includes the consideration of stock-in-trade because under the ACVM Act a product cannot be imported, manufactured, sold or used if it does not comply with the conditions of its registration (or other approval).

It is recognised that:

• registrants may have significant quantities of labels for a range of pack sizes on hand, and
• ‘old’ stock will be held by retailers and/or users.

ERMA New Zealand and the ACVM Group have been working with industry to minimise the impact in the area of stock-in-trade. The ACVM Group has worked to the basic principle that, in most cases, the best way to deal with stocks of products with old labels is for it to be used as it was originally intended. The exception would be if the combination of old and new labels was contradictory to current legislation or cause for significant confusion.

Recognising this principle, both regulatory bodies are working towards a phase in period for getting updated labels on packs in the market place, rather than a ‘drop dead’ date for compliance. This takes into account the potential for long lead in times for relabelling (particularly where the labelling is done overseas) and the relatively high cost of changes. It is hoped that the phase in period should avoid most instances of having to relabel stock-in-trade. At this stage a period of two years (from 1 July 2004) is being suggested. 

Industry is providing advice to the ACVM Group and to ERMA New Zealand through Agcarm on what they consider an appropriate phrase in period. Rationale to support the period is also being collated. This advice will assist in setting ERMA requirements for a phrase in period. The ACVM Group intends, as much as possible, to use the same criteria. Hopefully this will fit in with the majority of industry needs. Registrants and/or retailers who fail to comply with this phase in period will be subject to ACVM Group compliance activity.

It is hoped to have guidelines in place for a phase in period by January 2004 at the latest. Information will be advised on the ACVM and ERMA websites.