Significant change:Change in the shelf-life or storage conditions of the finished product: - Extension of the shelf life of the finished product - After dilution or reconstitution (supported by real time data) -
Change in the specification parameters and/or limits of the finished product.
Change in the specification parameters and/or limits of the finished product: - Qualitative or quantitative changes in one or more excipients that may have a significant impact on the safety, quality, or efficacy of the veterinary medicinal product.