The new article is dedicated to the rapid alert system implemented by the authority in order to ensure the important safety-related information associated with healthcare products allowed for marketing and use in the country is communicated and shared without undue delay.
Table of content
The Egyptian Drug Authority (EDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to recalls for medical devices. The guidance provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature. Moreover, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Implementation of Recall
The scope of the guidance covers, inter alia, the aspects associated with the implementation of a recall to be conducted in order to ensure continuous safety of medical devices and other healthcare products allowed for marketing and use in the country.
Stepwise Recall Procedure
First of all, the authority states that when a product or batch is identified for recall, the owning company or product agent must be informed immediately. The authority will form a committee from competent departments to ensure all parties adhere to the recall process, follow the time plan based on the recall category, and identify any weaknesses.
This committee will communicate with the product-owning company, importing agent, distribution companies, and public and private pharmacies, and track each step of the recall process. A file will be opened by the committee, detailing all information related to the recall.
Notification and Record-Keeping
The guidance further outlines the following principles:
- Immediate Notification: The company owning the product or the agent must inform the Authority about the product distribution as soon as they are notified of the recall.
- Recall Record: The company must review the information about the defective product/batch, enter details in the “Recall Record” and assign a unique recall reference number representing the month and year of the recall initiation.
- 24-Hour Notification: Within 24 hours of the recall decision, the company or responsible head of quality must notify the distribution company or store to stop further distribution and reserve the available quantities, using the fastest communication methods (e.g., email, phone, fax, SMS).
Product Withdrawal
The actual product withdrawal includes the following steps:
- Product Withdrawal Notice: The product-owning company or agent must send a withdrawal notice to the distributor, explaining the defect severity and instructing them to reserve quantities and withdraw the product from the market.
- Distribution Check: The distributor must check their distribution history to identify affected customers and warehouses and send recall notices to them for necessary action.
- Stock Reconciliation: The head of the main store or sales sector must ensure that product circulation has stopped and keep the available stock. All branches must send Return Notes with merchandise (if any) to the main store, and all returned stocks must be sent to storage warehouses.
Reporting and Documentation
The guidance also highlights the key points related to reporting in the context of recalls associated with healthcare products.
- Periodic Reports: The head of the main store or sales sector must send periodic reports to the product owner or agent, detailing available stock and returns received from branches. These reports should also be sent to the competent department of the EDA.
- Final Reconciliation: The head of the main store or sales sector should reconcile the recalled stock against the total quantity received and complete the “Product Summary Report/Batch Recall”. Copies should be sent to the product owner or agent and the EDA for review and further action.
Review Phase
In addition to the above, the document also describes in detail the activities taking place during the review phase.
Follow-Up Procedures by the EDA
As explained in the guidance, follow-up procedures associated with recalls include:
- Inventory of Returned Products: EDA inspectors will inventory all quantities returned from distribution companies to the product-owning company and match them with the quantities in the company’s stores.
- Quarantine: Returned products must be placed under “quarantine” and stored securely until EDA inspectors decide on further action.
- Final Report: EDA will issue a final report detailing observations on the recall process, identifying strengths and weaknesses, and recommending any corrective measures.
Factors for Evaluating the Recall
As explained by the EDA, when evaluating the effectiveness of a recall, the following factors should be taken into consideration:
- Production and Distribution Details: Factors such as the batch production date, the time between production and recall publication, product consumption rate, and quantities distributed to pharmacies and held by the product owner or agent.
- Destruction of Recalled Products: All recalled quantities must be destroyed within three months of the recall letter or voluntary recall request unless an extension is justified and approved by the authority.
Follow-Up Procedures by the Product Owner
In accordance with the applicable legislation, certain follow-up procedures should be completed by the parties responsible for the products in question – product owners. The exact obligations would depend on the class of a recall under the applicable clarification system.
Class II Recalls
For Class II recalls, follow-up procedures to be completed by a product owner should include:
- Effectiveness Check: The effectiveness of the recall should be checked, and the cause investigated. Remedial actions must be taken to prevent recurrence.
- Monitoring: The Licensee/Representative/Head of Quality Assurance should monitor the recall process and place returned products under “quarantine” until further decisions are made.
- Physical Examination: A physical examination of the recalled products should be conducted, and samples collected for investigation to determine the defect’s root cause.
- Impact Assessment: An impact assessment should be conducted on other product runs and the traceability of defective raw materials determined to identify affected batches/products.
Class I Recalls
In the case of a Class I recall, the scope of responsibilities associated with a follow-up would include:
- Data Monitoring: Relevant data such as material, plant, and lot numbers should be monitored to determine raw material traceability in different formulations.
- Stock Overview: Monitor material movement to get a complete stock overview and verify physical stock against records.
- Random Sampling: A plan for random sampling should be made to verify product effectiveness and safety.
- Withdrawal Decision: A decision to withdraw any affected batches should be made after evaluating the product quality.
- Disposal Instructions: Based on investigation results, the Head of Quality Assurance or authorized representative should instruct the distributor/marketing company to dispose of the returned merchandise appropriately, following regulations.
Conclusion
In summary, the present EDA guidance describes in detail the most important phase of a recall – its actual implementation. The document also outlines the key points associated with the review stage including, inter alia, follow-up activities to be conducted by both the EDA and product owner.
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