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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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1. on request from the licensee or registrant, the existing licence or registration could be cancelled and a new registration issued; or
2. regulations will be made under section 88 of the ACVM Act to deem the existing licences or registrations to be registered under the ACVM Act.
Mechanism 1 can be used immediately for any trade name product that is not a hazardous substance. It can also be used for the transfer of a trade name product that is exactly the same as the existing licensed/registered products (i.e. no drift in specifications or change in public health or environmental risks) if the request is made by the licensee or registrant.
This is possible because the ACVM Group and ERMA NZ have an understanding that the existing licences or registrations are considered to fulfill the requirement of an ERMA NZ approval until the relevant substances are transferred into the main framework of the HSNO Act.
As for the use of the second mechanism (regulations under section 88) there is a proposal to make such regulations (see page 6).
Although the ACVM Group has encouraged licensees and registrants to request the transfer of licences or registrations sooner rather than later, it may be better to participate in the consultation process on the regulations and await the outcome. If the regulations are made as the ACVM Group proposes, the transfer process would be greatly simplified.
Cancellation of licences for products that are exempt from registration
Until the transfer regulations are made the ACVM Group will cancel an existing licence on request from the licensee. Maintaining an animal remedies licence is not necessary to ensure products stay legal under the transitional provisions of the HSNO Act. However, it is recommended that you obtain a class determination first to ensure that your product is actually exempt from registration.
If the transfer regulations are made as the ACVM Group proposes, then all animal remedy licences will be cancelled and a specific request will not be necessary. The ACVM Group will report regularly on progress in making the regulations.
Cancellation of pesticide registrations
Pesticide registrations are important in regard to the transitional provisions of the HSNO Act. Premature cancellation may make product illegal. The ACVM Group will discuss this matter with any registrant who requests a registration to be cancelled to ensure that the consequences are understood.
Fertiliser registration
All fertilisers and fertiliser additives are exempt from registration but they must comply with the standards prescribed in Schedule 5 of the ACVM Regulations 2001. Products that have been registered as fertilisers in the past but used for another purpose (e.g. hydrogen cyanamide or phosphorous acid) do not fit the definition of a fertiliser and must now be registered.
ACVM Act transfer separate from HSNO Act transfer
The ACVM Group would like to remind people that transferring animal remedy licences and pesticide registrations to registrations under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 is a statutory requirement.
The Group would also like to point out that it is completely separate from the transfer of substances to the main framework of the Hazardous Substances and New Organisms (HSNO) Act 1996.
The ACVM Act transfer focuses on trade name products as defined by their formulation and use specifications. Transfers can be made totally independent of ERMA NZ approvals. However, even though a trade name product licence or registration is transferred under the ACVM Act, it may still have to be transferred to the main framework of the HSNO Act at a later date, which must be before the end of the transition period (2 July 2004).
Transfer under the HSNO Act focuses on substances across the range of concentrations, formulations and uses. While a substance could be defined in the same manner as a particular trade name product, that is not necessarily the case. In fact it is unlikely that ERMA NZ approvals will be based on trade name product formulations.
It is anticipated that animal remedy licences and pesticide registration transfers will be completed in the near future (see article on transfer via regulations, page 6).
However, the ACVM Group has been advised by ERMA NZ that the transfer of all substances into the main framework of the HSNO Act may take up to the end of the transition period.
Parties are advised to contact ERMA NZ directly if they have any enquiries about the transfer of substances under the HSNO Act. Advice from the ACVM Group is specifically about transfer under the ACVM Act only.
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