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NOTE: This is an archived issue. The current issue of AgVetLink can be found at http://www.nzfsa.govt.nz/acvm/publications/agvetlink/
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Transfer of trade name products to new legislation
On 2 July 2001 the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 and the hazardous substances provisions of the Hazardous Substances and New Organisms (HSNO) Act 1996 commenced.
Trade name products (TNPs) that are currently registered/licensed under the Pesticides Act 1979 and the Animal Remedies Act 1967 have up to three years to be transferred to registrations under the new legislation.
Some trade name products will be exempt from the requirement to be registered. However, this article is about those products that require registration.
Transfer processes
There are two separate processes required to transfer relevant registered/licensed TNPs to the new legislation, and these must be carried out within the specified transition period. If trade name products are not transferred within this period, they will become illegal. (The ACVM Group will advise proprietors who have not initiated the transfer of their products as the end of the transition period draws closer.)
These two processes are:
1. classification of TNP under the HSNO Act; and
2. transfer of TNP (animal remedies and pesticides) to the ACVM Act.
Classification under HSNO Act
Under the HSNO legislation ERMA New Zealand will classify substances as hazardous substances when they trigger any of the hazard thresholds set under the Act. Substances that are not hazardous will not be regulated under the HSNO Act. After classification, ERMA New Zealand will assign controls and transfer them to the main framework of the HSNO Act. In some cases the substance will be a single chemical entity, but in other cases the substance will be defined by the total formulation of a trade name product. It is up to the applicant to define the substance.
Transfer of TNP (animal remedies and pesticides) to the ACVM Act
The ACVM Group will transfer those currently registered/licensed TNPs that are agricultural compounds to the new legislation. Existing licences/ registrations will be adjusted to reflect the requirements under the ACVM Act, and new registrations will be issued.
These processes are separate but ERMA New Zealand staff will be working closely with ACVM staff to ensure the transfer to both Acts is co-ordinated. For those TNPs that are not hazardous substances, the ACVM Group will process the transfers but will notify ERMA New Zealand of its intention. If a TNP is a hazardous substance, the ACVM Group cannot transfer the licence or registration until the appropriate approvals have been issued by ERMA New Zealand.
Registration and Product Datasheet
The ACVM Group and ERMA New Zealand require similar information in order to transfer TNPs under their respective legislation. To avoid unnecessary duplication of information during the transfer process a Registration and Product Datasheet has been designed to summarise this information for both parties (see box at right).
It is proposed that this Registration and Product Datasheet be completed by holders of all currently registered/ licensed TNPs for each product and returned to the ACVM Group as soon as possible. This will allow:
- accurate details of each product to be agreed upon by the registrant/ licensee and the ACVM Group;
- information to be assembled for the public register;
- information to be collated to permit the hazard classification of that product under the HSNO Act; and
- non-hazardous products to be transferred without ERMA New Zealand approval.
Inappropriate contact personRecently an applicant companys regulatory affairs person knowingly contacted an ex-employee of the ACVM Group to request information on a product application. Needless to say, the ACVM Group considers this behaviour to be extremely inappropriate and treats such incidents very seriously. Any queries on applications for the registration of products must be directed through the designated Customer Services Officer (CSO) who will liaise with the ACVM staff concerned to get a response as soon as possible. It is important that direct contact with technical staff is kept to a minimum to ensure that the bulk of applications are processed as quickly and efficiently as possible. In addition, some ACVM staff members are not contracted full time to the Group and have obligations to other parts of MAF. If you are not satisfied with the response from the CSO, then your concern should be directed to Maree Zinzley (Customer Service & Approvals Manager), or escalated to Brian OSullivan (National Manager, ACVM Approvals) or Debbie Morris (Director, ACVM Group). |
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