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AgVetLink: Number 51, August 2005

Registrants must provide information

On a number of occasions recently it has been necessary to remind registrants of the condition on registrations providing for ongoing obligations which states:

The registrant must provide an annual summary of adverse events to the ACVM Group.  Adverse events that have serious implications for the continued use of the product must be notified immediately.

The registrant must also advise the ACVM Group of any new studies or data that contradict information previously supplied.

New information

New information includes research or trial results or even field observations that:

•         contradict the information provided during registration or

•         would prompt a reassessment from an altered perspective of the information provided during registration.

The intent of this condition is to ensure that registrations continue to be based on current relevant information. This includes not only information that supports the existing approval but also any information that apparently contradicts the information that was initially provided, whether or not it is believed the risks are still managed or there is opposing information.

Post-registration trials

A number of trials are carried out post- registration for ongoing stability, marketing, new claims and other regulatory requirements. These results must be supplied not only if they detract from the established efficacy, safety, residues and shelf life but also if they change the rationale on which the approval was based. The ACVM Group will consider the post registration information as new for the purposes of a reassessment under section 29, if necessary.

Application declaration

Applicants are also reminded that an application for registration must contain any information or studies that are contradictory in order for them to sign the declaration truthfully.