What action should be taken if a regulatory change affects previously approved products?

When a regulatory change impacts previously approved products, the most appropriate action is to assess the impact and update product documentation accordingly. This process is crucial because regulatory requirements can dictate how products are labeled, marketed, and even manufactured. By assessing the impact, organizations can understand the specific areas where their products may need adjustments to remain compliant with the new regulations.

Updating product documentation is essential not only for legal compliance but also for maintaining product safety and efficacy. Accurate documentation reflects adherence to current regulations, ensuring that the product meets necessary standards for quality and safety in the market. This systematic approach aids in mitigating risks associated with non-compliance, which could include penalties, recalls, or loss of market authorization.

Other options, such as ignoring the change, conducting an internal audit, or notifying consumers, do not directly address the need for immediate regulatory compliance and updating documentation. Ignoring changes poses significant risks, and compliance audits, while important, are typically secondary to the necessity of making immediate adjustments in documentation. Likewise, consumer notification is often not required solely based on regulatory changes unless those changes directly affect user safety or product quality. Therefore, moving to assess impact and update necessary documentation is fundamentally the correct course of action in these situations.