Help with the Safety and Expert Reports for a veterinary product regulatory submission

Client

A large European company developing insecticidal formulations for use as Veterinary or Biocidal Products.

Background

Veterinary products are regulated in Europe under a Community centralised authorisation procedure. Any product placed on the market must have a marketing authorisation and companies must provide a data dossier to support their application. In response to comments received by the regulator on a previously submitted dossier, the client company sought bibra’s expert help to upgrade their dossier and address a number of concerns made by the competent authority.

Project Goals

To review and improve the safety dossier submitted as part of an application for approval of a topical insecticidal veterinary treatment for dogs. Identify any additional key data on the active ingredient and format the endpoint information so that it is coherent and easy to follow. Provide expert comment on the endpoint summaries and risk assessment conclusions described in the safety dossier.

Approach

The safety and risk assessment parts of the dossier were provided by the client, together with critical comments received from the regulatory authority tasked with reviewing the earlier submission. The safety dossier was reviewed by bibra to ensure that key data were included and that the information was presented in a coherent and understandable way, following European Commission guidance on the presentation and content of dossiers for veterinary products. The user risk assessment was amended to address new exposure details, and expanded to include additional relevant information on substances of concern within the formulation. Bibra also provided expert comments on the presented endpoint summaries and the overall risk assessment conclusions.

Project Outcome

In a short time frame, bibra reviewed and upgraded the safety dossier to address regulator concerns and ensure compliance with relevant guidance. Expert comments on the endpoint summaries and overall risk assessment conclusions were provided, allowing timely re-submission for the authorization approval.

Project Leaders

Philip Copestake

 

Animal feed and vet products

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