Table of contents
The SFDA issued in 2023 a new regulation for products 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.
- Drug intended for use in human and animals.
- Human herbal product.
- Human health product.
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.
Responsible Supplier is the entity that initiate 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.
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 life-threatening or serious risk probability is remote.
- Class 3: The defect is unlikely to cause harm to the patient, and the recall 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||The responsible supplier should immediately notify SFDA when they become aware of a possible defect. The responsible supplier should submit the required information using their own recall reporting form or the product recall reporting form (SFDA form).|
|Hazard/risk assessment, recall action assessment and agreement||The classification and level of recall action 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|
|Phase 2. Implementation||Communication and distribution of recall letter||The recall strategy should define the method and content for all communications associated with the recall. The content of recall communication include: A description of the product,The reason for the recall.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 chain of distribution to notify their own customers of the recall and to provide instructions on how to proceed to recall the affected product.Expected recall action termination date (the maximum period for recall action is 12 weeks from the receipt of the recall letter)|
|Communication timelines||After receiving recall letter from SFDA, the responsible supplier should initiate recall action and contact with affected entities immediately.|
Review / Close Out –
|Progress report||Progress reports should be provided to SFDA during the course of the recall. The progress reports should be submitted daily. Recall progress reports should normally specify: number of recipients notified of the recall.number of respondents.number of non-respondents.next expected follow-up date with non-responders and method of communication.the quantity of stock returned or corrected.|
|Final report||When the recall is complete, responsible supplier should provide SFDA a final report (close-out) that should specify the following: An investigation report.In the case of a product recall, the intended destruction method of the product by a specialized medical waste company (the responsible supplier should notify the SFDA about the proposed date and the site for product destruction to be witness by SFDA representative).In the case of a recall for product correction, confirmation that the product correction has been applied to all units with customers.|