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AgVetLink February 2005

Transfer update: veterinary medicines

(Article provided by ERMA)

The Transfer of Substances Group is currently working on the transfer of veterinary medicines (formerly licensed animal remedies) to HSNO. Consultation on the classifications and controls for most types of veterinary medicines has been completed.

To date, ERMA has approved the transfer of parasiticides (such as ivermectin drenches) and other large volume products (such as bloat remedies), and small-dose form, finished-product veterinary medicines (such as vaccines and antibiotics). The main types of veterinary products still requiring consultation are the dietary modifiers and electrolytes. We are on track to meet the scheduled transfer date of 1 July 2005.

Concerns

From the consultation undertaken on veterinary medicines over the past 12 months, it has become apparent that there is some confusion over certain HSNO controls. Concern has been expressed about the intent of some controls and what is required to be compliant with them.

Labelling

One of the concerns relates to labelling and problems that may arise for products imported from overseas. These matters can be worked through, and a number of options are available for meeting the requirements, including the use of product inserts.

Storage

The requirements that apply to the storage of large volume products on farms and in veterinary clinics are also an issue of concern. We are continuing to discuss these matters through meetings with interested parties, such as the New Zealand Veterinary Association, and at farm visits organised by Federated Farmers.

Transition period

As was the case when pesticides were transferred, there will be a period of transition before the controls are required to be implemented, providing more opportunity to discuss and communicate workable solutions to the issues raised.

Avoiding duplication

Other controls have been varied considerably to avoid regulatory duplication with the Agricultural Compounds and Veterinary Medicines (ACVM) requirements. For example, the approved handler and tracking controls for many products have been removed, particularly if the products have prescription animal remedy (PAR) status under ACVM.

Matters to be resolved

Two matters are yet to be resolved. Firstly, a final decision needs to be taken on whether an approved handler should be required when ecotoxic veterinary medicines are sprayed. This relates mostly to ectoparasiticides. ERMA New Zealand has made it clear that the final decision is yet to be reached.

Another matter that requires further work is the processing of veterinary medicines that were not notified under the Toxic Substances Act. Because the transitional provisions of HSNO did not include veterinary medicines, these substances were required to be notified.

A strict view would be that if a product was not notified, it cannot be transferred and we have advised all manufacturers with non-notified products of the situation. There are a number of options available to bring these products under the HSNO regime, and we are currently working with companies on this.

No fundamental problems

The concerns being raised now with veterinary medicines are not dissimilar to the concerns expressed in the lead-up to the transfer of pesticides that, nine months on, have not resulted in any fundamental problems. New Zealand’s agricultural sector continues to operate in much the same way that it has in the past. ERMA New Zealand is committed to ensuring that veterinary medicines are transferred with minimal disruption to manufacturers and end users.

Contact

If you have any queries, please do not hesitate to contact Jim Waters:

Phone: 04 918 4816

Email: jim.waters@ermanz.govt.nz