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Update versus review

Over the next three years the ACVM Group will be transferring licences and registrations under the old legislation to registrations under the ACVM Act. Right from the start, the Group would like to clarify the difference between updating and reviewing licences/registrations.

Updating licences/registrations

Every animal remedy licence and pesticide registration must be updated as part of the transfer process. Updating involves using existing information about a trade name product and confirming that the transfer can be made safely. Licence and registration numbers will be converted and the condi-tions will be adjusted to reflect the requirements of the ACVM (see article on ACVM registration conditions, page 6). New informa-tion will not have to be provided by the licensee or registrant (see page 3). The data on the trade name product will not be re-viewed.

Reviewing licences/registrations

There will be a few trade name products that have over time posed new risks that were not addressed when they were origi-nally licensed. There may be significant uncertainty about the new risks posed by a trade name product or about the appropriate conditions that would be needed to manage those risks. In those few cases the data held on the product will be reviewed and the licensee/ registrant may even be asked to provide new information/data to facilitate the review.

Policy on review of information prior to transfer of licences or registrations

All present licences and registrations will be updated as they are trans-ferred to regulatory control under the ACVM Act. Wherever possible the ACVM Group will use information it already has to transfer the licences or registrations of trade name products. In most cases it will not request the applicant to provide any new data. However, there will be circum-stances in which the transfer of a licence or registration cannot be made without concerns that the risks may not be adequately managed. In such cases there will be a review carried out before the licence or registration is updated.

Where the information gaps are minor from a risk management perspec-tive, the transfer can still be completed without new information. Concerns will be considered minor if the lack of information does not prevent the making of a technically sound registration decision

Where a registration decision could be made but there is further informa-tion that would be needed to refine the conditions, either:

• a limited registration period may be imposed, to allow the registrant to adequately address the concerns before the termination of the new registration period; or
• more stringent/limiting conditions may be imposed to manage the risks in the face of uncertainty, and could include conditions on importation, manufacture, sale and especially use.

When more restrictive conditions are applied, registrants would have to apply for a change in the registration and provide the supporting informa-tion if they wish to have the conditions modified.

There will be a few occasions in which the level of uncertainty is too great to make either of the above options appropriate. On such occasions the ACVM Group may request new information. The new information will have to be reviewed before a registration decision is made.

The following are rules for when a review of new information may be carried out:

• if the information held by the ACVM Group is inadequate to set appropriate conditions (even more stringent ones than are presently imposed on the licence/registration); and
• there may be adverse consequences if the conditions that seem appropriate (given the information held by the ACVM Group) were applied.

The potential for adverse consequences will be judged on:

• a history of adverse events; or
• scientific or public expressions of concern about the specific trade name product or products similar to the one in question.

Registrants/licensees will be advised if new information is required. It is expected that new information will not be required in most cases.