Algeria: ANPP Publishes a New Guideline on Batch Recall and Withdrawal of Non-Compliant Pharmaceutical Products and Medical Devices
Publication date: 18 January 2026
The National Agency for Pharmaceutical Products (ANPP) of Algeria has published a new regulatory guideline entitled “Guideline on Batch Recall and Withdrawal of Non-Compliant Pharmaceutical Products and Medical Devices” (Code: Gd-DVIV01/V01).
This guideline establishes a structured regulatory framework governing the recall, withdrawal, and destruction of non-compliant pharmaceutical products and medical devices, with the primary objective of protecting public health and ensuring strict compliance with Algerian regulatory requirements.
Regulatory Context and Purpose of the Guideline
The new ANPP guideline aims to:
Eliminate non-compliant, defective, falsified, or potentially harmful products from the market;
Preserve the quality, integrity, and safety of pharmaceutical products and medical devices throughout their lifecycle;
Ensure consistent and documented implementation of recall, withdrawal, and destruction processes;
Strengthen regulatory oversight in accordance with Law No. 18-11 relating to health and related implementing texts.
This publication reflects the ANPP’s commitment to reinforcing market surveillance and post-market control mechanisms in Algeria.
Scope of Application
The guideline applies to all stakeholders involved in recall, withdrawal, and destruction activities, including:
The National Agency for Pharmaceutical Products (ANPP);
The Ministry of Pharmaceutical Industry (MIP);
The Ministry of Health (MS);
Pharmaceutical establishments (manufacturers, importers, distributors);
Healthcare institutions and community pharmacies.
Key Definitions and Concepts
The guideline clearly defines critical regulatory concepts, including:
Batch suspension (quarantine): temporary suspension of distribution and use pending investigation;
Batch recall: corrective action to retrieve distributed non-compliant batches from the market;
Product withdrawal: removal of a product due to confirmed quality defects, lack of efficacy, or health risk, potentially accompanied by suspension or withdrawal of its registration or homologation;
Destruction: irreversible elimination of non-compliant, defective, or expired products;
Falsified products: products deliberately misrepresented regarding identity, composition, source, or history.
Recall and Withdrawal Processes
Risk Assessment and Classification
The guideline introduces a structured risk-based approach, classifying recalls into three categories:
Class I: Serious or life-threatening risk requiring immediate action within 48 hours and potential public communication;
Class II: Temporary or reversible health risk requiring action within 72 hours;
Class III: Minor defects not likely to cause serious health consequences but requiring corrective action.
Recall Implementation
Pharmaceutical establishments must:
Ensure full batch traceability;
Conduct documented risk assessments;
Implement recall actions promptly, whether voluntary or authority-driven;
Submit detailed recall reports, including quantities distributed and recovered;
Store recalled products in clearly identified and segregated areas.
Withdrawal and Destruction of Products
The guideline details:
Conditions for temporary suspension, definitive withdrawal, or market reintroduction;
Mandatory secure storage of withdrawn products;
Strict requirements for safe and environmentally compliant destruction;
Documentation obligations, including destruction reports and official destruction records (Procès-Verbal) retained for at least five years.
Destruction activities remain under the responsibility of pharmaceutical establishments and must comply with environmental regulations and ministerial authorizations.
Roles, Responsibilities, and Communication
The guideline clearly assigns responsibilities to:
ANPP: issuing recall or withdrawal notices, oversight, inspections, public communication, and handling falsified products;
Pharmaceutical establishments: execution, traceability, reporting, and mandatory notifications;
Ministry of Pharmaceutical Industry: validation of destruction requests and adjustment of import/production programs;
Ministry of Health and healthcare facilities: execution of recall and withdrawal instructions;
Ministry of Environment: oversight of waste disposal and destruction processes.
Communication obligations include recall notes, detailed reports, and public information where public health risks are significant.
Inspections, Enforcement, and Appeals
The ANPP may initiate inspections in cases of major non-compliance or suspected regulatory breaches.
Pharmaceutical establishments retain the right to:
Request reconsideration within 10 working days;
Seek temporary suspension of regulatory decisions, except in Class I emergencies;
Receive a final binding decision within defined timelines.
Strengthening Post-Market Control in Algeria
This guideline represents a major step toward harmonized, transparent, and enforceable post-market control of pharmaceutical products and medical devices in Algeria. It strengthens the national system for managing quality defects, safety risks, and falsified products, in line with international best practices.
Conclusion and Regulatory Support Services
The publication of the ANPP Guideline on Batch Recall, Withdrawal, and Destruction of Non-Compliant Products has significant operational and compliance implications for pharmaceutical companies and medical device operators active in Algeria.
Early assessment and alignment of internal procedures are essential to ensure effective recall readiness, regulatory compliance, and inspection preparedness.
Simon MedTech Solutions supports pharmaceutical and medical device companies with:
Gap analysis against Algerian recall and withdrawal requirements;
Development and update of recall, withdrawal, and destruction SOPs;
Recall simulation exercises and inspection preparedness;
Regulatory support during recall or withdrawal actions;
Ongoing regulatory intelligence and compliance monitoring in Algeria and North Africa
Contact us to ensure your recall and withdrawal systems are fully compliant with the latest ANPP regulatory requirements.
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