Labelling Regulations for Veterinary Biological Products Amended

The Department of Agriculture's Animal and Plant Health Inspection Service has amended effective 8 September the Virus-Serum-Toxin Act regulations to provide for the use of a single uniform labelling format designed to better communicate the performance of veterinary biological products to the user. APHIS is also requiring biologics licencees to provide a standardised summary, with confidential business information removed, of the efficacy and safety data submitted to the agency in support of the issuance of a full product licence or conditional licence.

APHIS grants licences or permits under the VSTA and regulations issued under the Act for biological products that are pure, safe, potent and efficacious when used according to label instructions. The regulations prescribe requirements for the packaging and labelling of veterinary biological products, including requirements applicable to final container labels, carton labels and enclosures. The main purpose of the packaging/labelling regulations is to regulate the packaging and labelling of veterinary biologics in a comprehensive manner, which includes ensuring that labelling provides adequate instructions for the proper use of the product including vaccination schedules, warnings and cautions. Complete labelling (either on the product or accompanying the product) must be reviewed and approved by APHIS prior to its use.

APHIS indicates that the amendments will simplify the evaluation of efficacy studies, thereby reducing the amount of time required by the agency to evaluate study data. A novel veterinary biological product can generate revenue in the neighbourhood of US$5 to US$10 million per year. Increased efficiencies in the generation and evaluation of efficacy data should result in fewer delays in bringing a product to market. In addition, a simpler label may benefit those manufacturers, both large and small, who export their products, as foreign manufacturers do not use a tiered approach to label claims. The changes are expected to affect all veterinary biologics licencees and permittees, including approximately 100 veterinary biological establishments that produce about 1,900 different products.

Products that are not yet licenced but are within six months of licensure at the time these regulations become effective will be expected to be fully compliant no later than one year after licensure. Products that are more than six months away from licensure at the time these regulations become effective will be expected to be fully compliant at the time of licensure. For products that are currently licenced, the standardised summary of efficacy and safety data and the revised labels will have to be submitted to APHIS within four years of the time these regulations become effective.