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AgVetLink October 2003

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ACVM Group move to limited registration periods

Section 21(2) of the ACVM Act provides for registrations to be given a date of expiry. In the past the ACVM Group has not had expiry periods for the majority of full registrations but there was a requirement under the old legislation that certain information must be kept up to date.

Changes required

The ACVM Group has been dealing with a number of updates of products as we near the end of the transitional period, and we have noted that a high number are not ‘simple’ updates and actually require changes to be made. This means that the requirements of the previous legislation were not being met.

We also expect that, because of the complex nature of the interfaces that the ACVM Act has with other legislation, future changes in the ACVM Act and in related legislation will mean that ACVM risk management must be updated via changes in conditions on products. Changes to labels are likely to occur as a result.

Limited period

The ACVM Group is therefore proposing to introduce limited period registrations. For most products the period is likely to be three years, although where there are known changes likely to occur or other reasons prevailing it could be a shorter period. Wherever products are changed within the expiry period (as part of an application for such change), the expiry period would be for (up to) three years from the date of the approval of the change.

We are working to ensure that compliance costs will be minimised. The following are proposed as operational ‘rules’:

• Prior to the expiry date of the product, registrants will be reminded of the need to confirm product details.
• Registrants will be required to provide the Product Data Sheet (PDS) and to declare that there have been no changes to the registered product.
• Where there has been no change there will be no charge for the new registration certificate.
• Where there are label changes required the ACVM Group will work with the registrant to agree reasonable timeframe for implementation but this will be within a defined period.
• Where there are changes to the register required or where the change requires an application, normal charges will apply.

PAR Class II label wording

In the August 2003 issue of AgVetLink comments were requested on the proposal to change the mandatory label wording for veterinary medicines registered with a PAR Class II condition from:

"For use only in the presence of a veterinarian"

to:

"For use only by, in the presence of, or under the direct control of a veterinarian".

No comments were received on this proposal and the proposed statement.

Further review

However, the ACVM Group has further reviewed the wording requirements for products to line them up with the management of PAR products. The label wording for PAR Class II products will be:

"For use only by, in the presence of, or under the control of a veterinarian"

Conditions on registration

The conditions on registration will also be altered and will be:

1. For Sale:

"This product must not be sold by any person except an approved trader and to any person other than an approved trader, or under a veterinary prescription or authorisation."

2. For Use:

"This product must be used only by, in the presence of, or under the control of a registered veterinarian."

Discretionary use

In addition there is a proposed change to the wording of the ‘discretionary use’ registration condition on PAR Class II products (and other registered veterinary medicines) to:

"The product may be used at the discretion of a registered veterinarian, only when acting in accordance with the applicable ACVM standards unless that use is not permitted in the current registration."