Medicinal Product 
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Medicinal Products Regulatory Support in Algeria – Overview

Algeria’s pharmaceutical market is one of the largest in Africa, driven by healthcare expansion and increasing domestic manufacturing under government initiatives. The ANPP ensures that all medicinal products meet quality, safety, and efficacy standards before marketing or importation. To obtain Marketing Authorization (AMM), companies must submit a dossier in CTD format, comply with Good Manufacturing Practices (GMP), and meet local labeling and pricing regulations.

Freyr supports pharmaceutical manufacturers and importers through every Regulatory step — ensuring dossier accuracy, compliance with ANPP guidelines, and timely product approvals.

Medicinal Product Classification in Algeria

Medicinal products in Algeria are classified under the Law No. 18-11 (2018) and ANPP guidelines as follows:

• Prescription Drugs (Rx): Require medical supervision and can only be dispensed with a valid prescription.
• Over the Counter (OTC) Drugs: Approved for self-medication with proven safety and efficacy.
• Biologicals and Biosimilars: Require extensive comparability data and additional ANPP evaluation.
• Controlled Substances: Governed under narcotics control regulations and subject to specific licensing.

All products must be registered and authorized by ANPP before marketing, import, or distribution. The sale of unregistered drugs is prohibited.

Medicinal Product Registration & Approval Process in Algeria

Regulatory Authority: National Agency for Pharmaceutical Products (ANPP)
 Legislation: Law No. 18-11 (2018); Executive Decrees on Pharmaceutical Regulation

Key Steps:

1. Licensing
   
   1. The company must hold a valid Manufacturing Authorization or Import Authorization.
   2. Manufacturing sites must comply with GMP standards recognized by ANPP.
2. Dossier Submission
   
   1. Submitted in CTD format (Modules 1–5).
   2. Includes product information, CPP, GMP certificates, stability, and labeling data.
3. Technical Evaluation
   
   1. ANPP reviews dossier completeness and technical adequacy.
   2. Assessment covers quality, safety, efficacy, and reference country approvals.
4. Pricing Approval
   
   1. Prices are evaluated and approved by the Pricing Committee under the Ministry of Pharmaceutical Industry.
5. Marketing Authorization (AMM) Grant
   
   1. Issuance of AMM certificate, typically valid for 5 years.
6. Post-Authorization Requirements
   
   1. Import authorization for each batch.
   2. Labeling in Arabic and French.
   3. Pharmacovigilance reporting as per national requirements.

Specific Requirements by Product Type 

• Generics: Require bioequivalence data or scientific justification.
• Biologics/Biosimilars: Must comply with WHO and ANPP comparability guidelines.
• Vaccines: Require lot release and control by the National Laboratory for Control of Pharmaceutical Products.
• OTC Products: Simplified submission pathway but subject to strict labeling and safety criteria.

Post-Approval & Pharmacovigilance 

Registered products are continuously monitored by ANPP:

• Renewal: Every 5 years, with updated stability, GMP, and safety documentation.
• Variations: Any post-approval changes in formulation, labeling, or site must be pre-approved.
• Pharmacovigilance: MAHs must appoint a local Qualified Person for Pharmacovigilance (QPPV) and report Adverse Drug Reactions (ADRs).
• Market Surveillance: ANPP conducts sampling, inspections, and product recalls to ensure continued compliance.

Freyr supports full lifecycle management to maintain Regulatory compliance and product integrity in Algeria.