The new article provides additional clarifications regarding specific aspects associated with recalls, such as appeals to relevant decisions or disposal for medical products.
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.
Appeals Process
The scope of the guidance covers the aspects related to various appeals the parties involved could submit, should they disagree with a decision taken.
In this respect, the document highlights the following:
- Submission: Licensees or manufacturers have the right to submit a technical appeal directly to the head of CA of operation within fourteen days of the recall issuance, including all technical justifications.
- Investigation: These appeals are directed to the relevant decision-making body to investigate the issue and prepare a detailed report, including all related documents, for review by the head of CA of operation for a final decision.
- Grievance Committee: If applicants are unsatisfied with the initial decision, they may resort to the Grievance Committee. Appeals must be submitted within sixty days from the recall issuance date. A ruling on the grievance will be made within sixty days of submission.
Disposal of Recalled Products
Another important aspect addressed in the document relates to the disposal of reclassified products. In particular, the authority explains the way recalled products should be disposed of in order to mitigate additional risks.
As set forth under the existing legal framework, recalled medical products should be destroyed within three months of the recall letter issuance unless an extension is requested by the product licensee and approved by the EDA. This ensures the products do not re-enter the supply chain.
The Market Control Administration oversees the recall follow-up and disposal of unwanted medical products. Procedures for safe disposal described in the guidance apply to batches with non-conformity reports, defected batches, batches ordered for disposal by EDA committees or judicial authorities, batches with international disposal warnings, pilot batches, clinical trial, and R&D batches.
In particular, high-temperature incineration with adequate flue gas cleanup is recommended for safe disposal. The document further describes specific steps to be taken by the parties involved in the course of safe disposal.
Request for Disposal
Entities such as licensees, warehouses, pharmacies, hospitals, or organizations with pharmaceutical programs must follow these steps to request disposal:
- Documentation: Submit a letter approved and stamped by the company, addressed to EDA, including a product list, disposal location, and method, along with an email for service requests.
- Product List: Include product names, batch numbers, expiration dates, quantities, and weights.
- Environmental Approval: Provide the Ministry of Environment’s recent approval for the disposal site.
- Company Representative: Notify the person in charge of handling the disposal process.
- Pledge: Ensure the products are not pending prosecution.
Decision and Approval
During the next step, the abovementioned request should be reviewed and approved.
- Document Review: EDA reviews the submitted documents within five working days.
- Approval: If documents meet EDA criteria, the requester is informed to decide the disposal date within 14 days. Missing documents must be submitted within five working days, or the request will be canceled.
- Inter-Administration Coordination: If additional reports are needed, relevant administrations will be contacted to provide reports within five working days.
- Refusal: Reasons for refusal will be detailed, and a new request can be submitted after corrective actions.
Planning and Execution
The main part of the process includes the actual execution of the requested disposal.
- Planning: Human resources, professional time, space, equipment, material, and disposal options must be planned before starting disposal.
- Work Teams: EDA identifies auditors to participate in the committee formed by the service requester to supervise destruction. Teams include quality assurance representatives, warehouse representatives, pharmacists, financial representatives, and security representatives.
- Sorting: Pharmaceuticals are sorted into categories requiring different disposal methods. EDA auditors supervise the sorting and sealing of inventory items.
- Disposal: EDA auditors supervise the disposal process to ensure safety and compliance with the notified method and location. Any discrepancies must be reported and justified within 24 hours.
Specific Disposal Procedures
According to the guidance, in certain cases, specific disposal procedures should be followed.
This includes:
- IMP and Surplus Human Samples: Notify the administration of protocols and studies follow-up with required documents. After destruction, send the destruction minutes to the Central Administration for Operations.
- Landfill: Use engineered or sanitary landfills; avoid open, uncontrolled dumps.
- Waste Immobilization: Encapsulation or inertization methods for immobilizing pharmaceuticals.
- Sewer: Small quantities of liquid pharmaceuticals can be diluted and flushed into sewers.
- Incineration: Prefer high-temperature incineration with proper emissions control.
Recommended Disposal Methods by Product Type
The document also provides additional recommendations to be considered by the parties involved based on the type of the product subject to disposal:
- Antineoplastic Drugs: High-temperature incineration or waste immobilization; never landfill or sewer.
- Anti-infective Drugs: High-temperature incineration or waste immobilization; liquid forms may be diluted and flushed.
- Disinfectants: Use for cleaning or dispose of in chemical waste facilities; avoid large quantities in sewers or watercourses.
- Pesticides: Ship out of the country.
- Solids, Semi-solids, and Powders: Incineration or encapsulation; landfill if no other method is available.
- Liquid Pharmaceuticals: Dilute and flush into sewers if no sewers, dilute with water, and pour into large watercourses.
- Ampoules: Crush and dispose of in landfills; avoid incineration due to explosion risk.
- Aerosol Canisters: Landfill disposal if not containing poisonous substances; avoid burning or incineration.
Conclusion
In summary, the present EDA guidance describes in detail not only the procedure of recalling medical devices from all potential users or distributors but also their safe disposal, taking into account environmental considerations.
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