In 2023, the SFDA issued a new regulation on product recalls from the market. The objective is to ensure that in the event of a necessary recall, the responsible supplier effectively and efficiently carries out the recall operations through pharmacovigilance and other related departments, such as the supply chain, sales, and company management.
Table of contents
Scope
- Drugs intended for use in humans and animals.
- Human herbal product.
- Human health product.
Definitions
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 initiates a recall process and is primarily responsible for the supply of products in Saudi Arabia. It includes manufacturers, marketing authorization holders, scientific offices, importers, agents, distributors, and retailers.
Recall Action Classification
- Class 1: The defect presents a life-threatening or serious risk to health.
- Class 2: The defect may cause mistreatment or temporary harm to the patient, but the probability of life-threatening or serious risk is remote.
- Class 3: The defect is unlikely to cause harm to the patient, and the recall is carried out for other reasons.
Recall Action Level
- Wholesale level
- Retail and hospital level.
- Consumer or patient level
Recall Action Process
| Phase 1. Initiation | Notification and problem identification | After receiving a recall letter from SFDA, the responsible supplier should initiate recall action and contact the affected entities immediately. |
| 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 | Progress reports should be provided to SFDA during the recall and 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. |
| Communication timelines | Progress reports should be provided to SFDA during the recall and 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) |
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