Morocco Product Registration & Certification
Important Notes
- MoH & ANSM Centralized Regulation: Pharmaceuticals, medical devices, cosmetics, and food supplements are regulated by the Ministry of Health and the National Agency for the Safety of Medicines and Health Products (ANSM), requiring Marketing Authorization or notification.
- Food Supplements as Independent Category: Vitamins, minerals, plant extracts, etc., are explicitly classified as "Food Supplements," requiring a complete notification dossier to ANSM. Claims are strictly limited to nutritional/physiological functions, with any therapeutic implication prohibited.
- Mandatory Local Marketing Authorization Holder: Foreign manufacturers must appoint a local legal entity in Morocco as the Marketing Authorization Holder, assuming full responsibility for registration, vigilance, quality, and commercialization.
- French Language Documentation & Labeling: All technical documents and labels must be in French. Labels must include MAH details, notification number (for supplements), and claims per specific Moroccan regulations.
- Separate Pricing & Reimbursement Systems: Drug prices require approval by the National Committee on Drug Prices. Medical devices and supplements have no government pricing but require participation in public hospital tenders.
- High Recognition of EU Standards: Regulations are highly aligned with the EU. ANSM accepts and expedites review of dossiers for products already approved by EU member states, EMA, or the French ANSM.
Morocco Specific Requirements
- Dual Regulatory & Commercial Hub for North Africa: Possesses the region’s most advanced healthcare infrastructure and regulatory system. ANSM approval serves as a strategic springboard into the Maghreb and carries high regional reputation.
- Coexistence of Public Procurement & Premium Private Market: Public hospitals rely on price-sensitive tenders, while premium private hospitals/pharmacies in Casablanca demand international brands and innovation, creating distinct market tiers.
- Rapidly Growing Preventive Health Consumer Market: Urbanization and a growing middle class drive demand for food supplements, cosmeceuticals, and OTC products, with high consumer preference for EU brands and science-backed claims.
- Concentrated & Professionalized Distribution Channels: Pharmaceutical distribution is dominated by a few large wholesalers; supplements and cosmetics are sold through pharmacy chains, supermarkets, and specialized health stores.
- Archetype of "Francophone" Regulatory Culture: Processes are formal, detail-oriented, and document-heavy. Official communication with authorities is in French, and deep understanding of local administrative culture is key to avoiding delays.
Medical Devices Registration
Regulatory Requirements
- Medical Device Marketing Authorization (Autorisation de Mise sur le Marché)
- Risk-based classification (Class I, IIa, IIb, III)
- Complete French technical documentation
- Quality Management System Certificate (ISO 13485)
- French and Arabic bilingual labeling and instructions for use
- Compliance with Moroccan Medical Device Regulation (Décret n° 2-10-281)
- Certificate of Free Sale (Certificat de Libre Vente)
- CE Certificate of Conformity
- Clinical Evaluation Report (if applicable)
- Performance verification data
- Test reports from accredited Moroccan laboratories
Main Process
- Product classification determination
- Technical documentation preparation and translation
- Quality management system review
- DMP registration application submission
- Local authorized representative appointment
- Technical documentation assessment
- Product sample testing
- Marketing authorization acquisition
Registration Timeline
9-18 months
Official Fees
MAD 40,000 - 800,000 (including application, evaluation, testing and registration fees)
Service Fees
$16,000 - $48,000
Regulatory System Overview
DMP
Moroccan Directorate of Medicines and Pharmacy (DMP)
Specialized regulatory agency under Moroccan Ministry of Health, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals and cosmetics
ONSSA
Moroccan National Office of Food Safety (ONSSA)
Under Moroccan Ministry of Agriculture, responsible for regulation, registration and market surveillance of food, food supplements and foods for special nutritional purposes
Ministry of Health
Moroccan Ministry of Health
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising the operation and policy implementation of DMP
Medical Devices Registration Process
Product Classification
Determine risk classification according to Moroccan medical device regulations (Class I, IIa, IIb, III)
Technical Documentation
Prepare complete French technical documentation including specifications, test reports, clinical data
Quality System
Provide ISO 13485 certificate or evidence of compliance with Moroccan quality system requirements
Local Authorized Representative
Appoint authorized representative (Représentant Autorisé) located in Morocco
DMP Registration
Submit complete medical device marketing authorization application to Moroccan Directorate of Medicines and Pharmacy
Cosmetics Registration
Regulatory Requirements
- Cosmetic Marketing Authorization (Autorisation de Mise sur le Marché)
- Complete Product Information File (Dossier d'Information sur le Produit)
- Product Safety Assessment Report (Rapport d'Évaluation de la Sécurité)
- Compliance with Moroccan Cosmetics Regulation (Arrêté du Ministre de la Santé)
- French and Arabic bilingual product labeling
- Good Manufacturing Practice certificate (BPF)
- Product stability test reports
- Microbiological testing reports
- Ingredient safety data
- Testing certificates from accredited Moroccan laboratories
Main Process
- Ingredient compliance assessment
- Safety assessment report completion
- Product information file preparation
- Cosmetic marketing authorization application
- Label compliance review
- Product sample testing
- Market access completion
Registration Timeline
7-14 months
Official Fees
MAD 20,000 - 300,000 (including application, testing and registration fees)
Service Fees
$10,000 - $26,000
Regulatory System Overview
DMP
Moroccan Directorate of Medicines and Pharmacy (DMP)
Specialized regulatory agency under Moroccan Ministry of Health, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals and cosmetics
ONSSA
Moroccan National Office of Food Safety (ONSSA)
Under Moroccan Ministry of Agriculture, responsible for regulation, registration and market surveillance of food, food supplements and foods for special nutritional purposes
Ministry of Health
Moroccan Ministry of Health
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising the operation and policy implementation of DMP
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Moroccan 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 French
DMP Registration
Submit cosmetic marketing authorization application to Moroccan Directorate of Medicines and Pharmacy
Product Testing
Complete necessary product testing in accredited Moroccan laboratories
Food Supplements Registration
Regulatory Requirements
- Food Supplement Marketing Authorization (Autorisation de Mise sur le Marché)
- Ingredient safety and quality evidence
- Compliance with Moroccan Food Supplement Regulation (Loi n° 28-07)
- French and Arabic bilingual labeling and instructions
- Good Manufacturing Practice certificate (BPF)
- Ingredient analysis reports
- Scientific justification for nutrition claims
- Stability study data
- Analysis reports from accredited Moroccan laboratories
Main Process
- Product classification determination
- Technical documentation preparation
- Safety evidence collection
- Marketing authorization application submission
- Label compliance review
- Product sample analysis
- Marketing authorization acquisition
Registration Timeline
8-16 months
Official Fees
MAD 25,000 - 400,000 (including application, analysis and registration fees)
Service Fees
$12,000 - $32,000
Regulatory System Overview
DMP
Moroccan Directorate of Medicines and Pharmacy (DMP)
Specialized regulatory agency under Moroccan Ministry of Health, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals and cosmetics
ONSSA
Moroccan National Office of Food Safety (ONSSA)
Under Moroccan Ministry of Agriculture, responsible for regulation, registration and market surveillance of food, food supplements and foods for special nutritional purposes
Ministry of Health
Moroccan Ministry of Health
Responsible for developing national health policies, pharmaceutical regulatory framework and public health strategies, supervising the operation and policy implementation of DMP
Food Supplements Registration Process
Product Classification
Determine product falls under food supplement category per Moroccan food regulations
Technical Documentation
Prepare ingredient analysis, safety evidence, nutrition claims in French
ONSSA Registration
Submit food supplement marketing authorization application to Moroccan National Office of Food Safety
Label Review
Ensure compliance with Moroccan food labeling regulations and bilingual requirements
Product Analysis
Complete ingredient analysis and safety assessment in accredited Moroccan laboratories