Authorising a veterinary medicine

This branch covers veterinary medicine authorisation and subsequent safety reporting, divided by the parts of the regulatory work: the framework and procedures, the application dossier, residue and environmental assessments, and pharmacovigilance. It leaves veterinary science and evidence, other forms of veterinary writing and human medicine authorisation to neighbouring branches.

• The veterinary regulatory framework and its procedures — legislation, guidance, competent authorities, authorisation routes and recent authorisation recommendations
• The veterinary dossier — dossier structure, administrative information, quality, safety and efficacy, generic applications and reduced data requirements
• Residues, withdrawal periods and maximum residue limits — consumer safety, residue depletion, withdrawal periods and dietary exposure assessment
• Environmental risk assessment of veterinary medicines — exposure screening, higher-tier assessment, regulatory changes and gaps in environmental protection
• Reporting adverse events for veterinary medicines — post-authorisation reporting responsibilities and routes for veterinary professionals, animal owners, authorisation holders and authorities