SUMMARY

A sunset clause refers to a regulatory provision that sets a predetermined expiration date or termination point for the marketing authorization of a product. This clause is often employed to ensure that authorized products undergo regular reassessment for safety, efficacy, and quality. When a sunset clause is triggered, the marketing authorization may expire unless the product undergoes a renewal process and demonstrates continued compliance with regulatory standards, as well as a three-year period without marketing of a medicinal product or in case of a complete marketing cessation of the product from the last date of release into the distribution chain of the medicinal product in some ML4 countries.
Marketing Authorization (MA) closing activity may occur due to various reasons, including product discontinuation, safety concerns, or the fulfillment of the product’s lifecycle. The MA closing activity typically involves notifying regulatory authorities, updating product information databases, and addressing any remaining regulatory obligations.
De-registration of the establishment involves formally notifying an National Regulatory Authority (NRA) when an establishment ceases operations or no longer manufactures regulated products, which involves removing the facility from its list of registered establishments. The Marketing Authorization Holder (MAH) is responsible for notifying an NRA if they wish to withdraw a product, and the product is no longer authorized for marketing. Typically, NRA require formal notification of the decision to withdraw a product from the market. This involves submitting necessary documentation and fulfilling any regulatory obligations, such as recalling existing stock or providing a transition plan for patients.