Algeria Product Registration & Certification
Important Notes
- MoH & National Drug Agency Centralized Control: All pharmaceuticals, medical devices, food supplements, and cosmetics require marketing authorization from the ANDP, under strict import quotas and localization policies.
- Food Supplements as "Foods for Special Nutritional Uses": Such products are regulated under this category. The required dossier and process can be uncertain and require case-by-case consultation.
- Mandatory Localization/Technology Transfer Policy: This is the highest-priority rule. For high-volume products, market authorization is often contingent on a commitment to localize production or transfer technology within a short timeframe.
- Importer Monopoly & Protracted Customs Procedures: Drug imports are monopolized by state-owned companies. Other imports face complex documentation and potentially lengthy administrative and customs reviews.
- French Documentation & Rigorous Consular Legalization: All documents must be in French and undergo strict legalization by Algerian consulates abroad. Any discrepancy leads to rejection.
- Extreme Scrutiny of Origin & Free Sale Certificates: Beyond standard documents, authorities may demand detailed proof of raw material origin and have specific requirements for the issuing body of the Free Sale Certificate.
Algeria Specific Requirements
- Archetype of "Resources-for-Market" Policy: Strong purchasing power from hydrocarbon revenues is coupled with mandatory local investment, job creation, and technology transfer as conditions for market access.
- Closed Market Dominated by Public Healthcare: Over 95% of healthcare is state-provided. The Ministry of Health is virtually the sole buyer, making market access synonymous with securing government contracts.
- Strong Administrative & Protectionist Regulatory Stance: ANDP decisions are influenced not only by science but also by national economic policies, forex conservation, and support for local industry, reducing flexibility and predictability.
- High Potential Contrasted with Operational Complexity: A large, stable market is offset by stringent localization laws, bureaucracy, forex controls, and monopolized distribution, creating high barriers.
- Benchmark for the Unique Francophone North African Market: Its extreme localization model is representative of the Maghreb region. Success here demonstrates capability to navigate the area’s most complex environment.
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate (Certificat d'Enregistrement des Dispositifs Médicaux)
- Risk-based classification (Class I, IIa, IIb, III)
- Complete Arabic technical documentation
- Quality Management System Certificate (ISO 13485)
- Arabic and French labeling and instructions for use
- Compliance with Algerian Medical Device Regulation (Décret exécutif n° 13-03)
- Certificate of Free Sale (Certificat de Libre Vente)
- CE Certificate of Conformity
- Clinical Evaluation Report (if applicable)
- Biocompatibility test reports
Main Process
- Product classification determination
- Technical documentation preparation and translation
- Quality management system review
- ANPP registration application submission
- Local authorized representative appointment
- Technical documentation assessment
- Registration certificate acquisition
Registration Timeline
10-20 months
Official Fees
DZD 600,000 - 10,000,000 (including application, evaluation, and registration fees)
Service Fees
$18,000 - $55,000
Regulatory System Overview
ANPP
Algerian National Agency for Pharmaceutical Products (ANPP)
Specialized regulatory agency under Algerian Ministry of Public Health, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals and cosmetics
Ministry of Health
Algerian Ministry of Public Health
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising the operation and policy implementation of ANPP
Standardization Institute
Algerian Institute of Standardization and Industrial Property (IANOR)
Responsible for developing Algerian Standards (Normes Algériennes), conducting product quality certification and conformity assessment to ensure products meet Algerian technical standards
Medical Devices Registration Process
Product Classification
Determine risk classification according to Algerian medical device regulations (Class I, IIa, IIb, III)
Technical Documentation
Prepare complete Arabic technical documentation including specifications, test reports, clinical data
Quality System
Provide ISO 13485 certificate or evidence of compliance with Algerian quality system requirements
Local Representative
Appoint authorized representative (Représentant Autorisé) located in Algeria
ANPP Registration
Submit complete registration application to Algerian National Agency for Pharmaceutical Products
Cosmetics Registration
Regulatory Requirements
- Cosmetic Registration Certificate (Certificat d'Enregistrement des Produits Cosmétiques)
- Complete Product Information File (Dossier d'Information sur le Produit)
- Product Safety Assessment Report
- Compliance with Algerian Cosmetics Regulation (Décret exécutif n° 12-32)
- Arabic and French product labeling
- Good Manufacturing Practice certificate (BPF)
- Product stability test reports
- Microbiological testing reports
- Ingredient safety data
Main Process
- Ingredient compliance assessment
- Safety assessment report completion
- Product information file preparation
- Cosmetic registration application
- Label compliance review
- Market access completion
Registration Timeline
8-16 months
Official Fees
DZD 300,000 - 2,000,000 (including application and registration fees)
Service Fees
$12,000 - $30,000
Regulatory System Overview
ANPP
Algerian National Agency for Pharmaceutical Products (ANPP)
Specialized regulatory agency under Algerian Ministry of Public Health, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals and cosmetics
Ministry of Health
Algerian Ministry of Public Health
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising the operation and policy implementation of ANPP
Standardization Institute
Algerian Institute of Standardization and Industrial Property (IANOR)
Responsible for developing Algerian Standards (Normes Algériennes), conducting product quality certification and conformity assessment to ensure products meet Algerian technical standards
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Algerian permitted substances list and restrictions
Safety Assessment
Complete cosmetic safety assessment report by qualified safety assessor
Product Information File
Prepare complete Product Information File in Arabic
ANPP Registration
Submit cosmetic registration application to Algerian National Agency for Pharmaceutical Products
Label Compliance
Ensure labels meet Arabic and French bilingual labeling requirements
Pharmaceuticals Registration
Regulatory Requirements
- Marketing Authorization (Autorisation de Mise sur le Marché - AMM)
- Complete registration dossier (Dossier d'AMM)
- Comprehensive quality, safety, efficacy data
- Compliance with Algerian Pharmaceutical Regulation (Loi n° 18-11)
- Arabic and French labeling and instructions
- Good Manufacturing Practice certificate (BPF)
- Stability study data
- Bioequivalence studies (if applicable)
- Clinical trial data
- Pharmacological and toxicological data
Main Process
- Product classification determination
- Registration dossier preparation
- Technical documentation compilation
- Registration application submission
- Technical evaluation and assessment
- Marketing authorization acquisition
Registration Timeline
18-30 months
Official Fees
DZD 1,500,000 - 20,000,000 (including application, evaluation and registration fees)
Service Fees
$25,000 - $75,000
Regulatory System Overview
ANPP
Algerian National Agency for Pharmaceutical Products (ANPP)
Specialized regulatory agency under Algerian Ministry of Public Health, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals and cosmetics
Ministry of Health
Algerian Ministry of Public Health
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising the operation and policy implementation of ANPP
Standardization Institute
Algerian Institute of Standardization and Industrial Property (IANOR)
Responsible for developing Algerian Standards (Normes Algériennes), conducting product quality certification and conformity assessment to ensure products meet Algerian technical standards
Pharmaceuticals Registration Process
Product Classification
Determine pharmaceutical classification and registration pathway (innovative, generic, etc.)
Registration Dossier
Prepare complete registration dossier including quality, safety, efficacy modules
Technical Documentation
Compile all technical documents including manufacturing process, quality control, stability data
ANPP Application
Submit pharmaceutical registration application to Algerian National Agency for Pharmaceutical Products
Comprehensive Assessment
Pass comprehensive technical evaluation, quality review and expert assessment by ANPP