Summary
The Veterinary Medicines Regulations 2013 establish a comprehensive regulatory framework for veterinary medicinal products in the UK, covering definitions, marketing authorisation requirements, manufacturing standards, wholesale distribution, advertising restrictions, classification and supply controls, record-keeping, pharmacovigilance, importation rules, and administration of products outside marketing authorisation terms (the 'cascade'). The regulations implement EU-derived requirements including Good Manufacturing Practice, Good Distribution Practice, and residue limits in food-producing animals.
Reason
This regulation represents EU-derived legislation retained post-Brexit without democratic review, imposing substantial compliance costs with questionable proportionality. The marketing authorisation system creates barriers to entry, limiting competition and availability of medicines particularly for minor species and rare diseases. The extensive advertising restrictions prevent accurate information flow between manufacturers and prescribers, distorting market competition. Record-keeping requirements across the supply chain impose disproportionate burdens on small veterinary practices and farmers. The cascade system, intended as an exception mechanism, is so complex it effectively restricts off-label use. While food safety and antimicrobial resistance concerns are legitimate, these objectives could be achieved through less restrictive means such as industry self-regulation, private certification schemes, or targeted liability rules rather than comprehensive product-level government control.