THE UK Government’s Veterinary Medicines Directorate (VMD) is to introduce a new veterinary medicines packaging surveillance scheme from February 2.
The move will change how the VMD assesses and monitors veterinary medicine packaging to ensure proportionate oversight whilst reducing regulatory burden on the animal health industry.
A group of products will be selected for packaging assessment by the VMD every three months. These products will be sourced from wholesalers, and all packaging components will be reviewed.
The assessment will verify that the packaging complies with the approved product information text (QRD) and the principles set out in the product literature standards. The VMD will then share the assessment findings with the market authorisation holder (MAH) for the product concerned within the three-month assessment period.
Where non-compliance is identified, the VMD will outline the necessary corrective actions to the MAH. These actions may range from requiring the MAH to update packaging at the next regulatory opportunity for low-severity issues, to requiring submission of a formal variation to correct mock-ups, and in the most severe cases, tracking the issue as a product defect. The timeframe for implementing these actions will depend on the severity of the specific issue(s) identified.
