In 2023, the SFDA issued a new regulation for product recall from the market. The objective is to ensure that in the event of a necessary recall, the recall operations are effectively and efficiently carried out by the responsible supplier through their pharmacovigilance and other related departments such as the supply chain and higher management.
Recall action is the term used to describe an action taken to resolve a problem with a product currently in use or available for use because of deficiencies in its quality, safety, or efficacy.
The Responsible Supplier is the entity that initiates a recall process and has primary responsibility for the supply of products in Saudi Arabia. It includes manufacturers, marketing authorization holders, scientific offices, importers, agents, distributors, and retailers.
| Phase 1. Initiation | Notification and problem identification | The classification and level of recall action are determined initially by the responsible supplier based on the assessment of the health hazard presented by the product. However, SFDA will review the classification and level of recall action and adjust it where appropriate |
| Hazard/risk assessment, recall action assessment and agreement | After receiving a recall letter from SFDA, the responsible supplier should initiate recall action and contact the affected entities immediately. | |
| Phase 2. Implementation | Communication and distribution of recall letter | After receiving a recall letter from SFDA, the responsible supplier should initiate recall action and contact with affected entities immediately. |
| Communication timelines | Progress reports should be provided to SFDA during the recall. The progress reports should be submitted daily. Recall progress reports should normally specify: the number of recipients notified of the recall, the number of respondents, the number of non-respondents, the next expected follow-up date with non-responders, the method of communication, and the quantity of stock returned or corrected. | |
| Phase 3. Review / Close Out – | Progress report | Progress reports should be provided to SFDA during the recall. The progress reports should be submitted daily. Recall progress reports should normally specify: the number of recipients notified of the recall, the number of respondents, the number of non-respondents, the next expected follow-up date with non-responders, the method of communication, and the quantity of stock returned or corrected. |
| Final report | The recall strategy should define the method and content for all communications associated with the recall. The content of recall communication includes a description of the product, the reason for the recall, and the actions to be taken by the recipient, including instructions to stop further distribution or use immediately, instructions for how to recall the affected product, instructions to all entities involved in the distribution chain to notify their customers of the recall and to provide instructions on how to proceed to recall the affected product, the expected recall action termination date (the maximum period for recall action is 12 weeks from the receipt of the recall letter) |
