Medicinal Product Support in Morocco
End-to-End Medicinal Product Regulatory Support in Morocco

Medicinal Product Regulatory Support in Morocco – Overview

Morocco’s pharma sector is overseen by the national Regulatory authority under the government’s health ministry, driving Regulatory affairs in Morocco. The Regulatory framework covers the drug approval process in Morocco, quality controls, pharmacovigilance, pricing and reimbursement, and post-market surveillance.

The country is increasingly seen as a strategic hub for companies aiming to reach both the local market and broader African regions, supported by growing manufacturing capacity, GMP compliance in Morocco, Regulatory reforms, and a stable environment.

Medicinal Product Classification in Morocco

Below is the official classification of pharmaceutical products in Morocco as established by the Ministry of Health and relevant published regulations:

Main Categories

1. By Prescription Status
   • Prescription-Only Medicines (including substances with special restrictions such as narcotics and psychotropics)
   • Non-Prescription Medicines (Over the counter, or OTC)
2. By Product Origin/Status
   • Locally Manufactured Products
   • Imported Finished Products
   • Imported Intermediate Products
   • Imported Bulk (to be processed or packaged locally)
   • Subcontracting: With processes performed in Morocco or abroad
3. By Therapeutic Class
   • According to the SmPC: (Summary of Product Characteristics)
     • Classified by active ingredient(s), dosage, pharmaceutical form, and intended therapeutic use (e.g., antibiotics, antihypertensives, antidiabetics, etc.)
4. Other Categories
   • Herbal (Plant-Based) Medicinal Products
   • Homeopathic Medicines
   • Biologicals (e.g., vaccines, blood products)
   • Veterinary Medicinal Products (with specific sub-classifications for animal health)
   • Medicated Foods (for veterinary use)
5. Special Controlled Substances
   • Products containing narcotic or psychotropic substances, or drugs prone to misuse/abuse, have specialized controls and sub-categories.

Summary

• Morocco officially classifies pharmaceuticals by prescription status (prescription-only/OTC), origin/status (local/imported/bulk/subcontracted), therapeutic class, and special content (narcotics, psychotropics, herbal, homeopathic, biologicals).
• Veterinary medicines and medicated foods are classified under related but distinct rules.
• Product packaging, labeling, and marketing authorization require disclosure of classification details for all products.

Medicinal Product Drug Registration & Approval

The drug approval process in Morocco is regulated by the Ministry of Health’s Directorate of Medicines and Pharmacy (DMP). Below is a summary of key steps for medicinal product registration in Morocco and Regulatory requirements:

1. Submission of Marketing Authorisation (MA) Application

• Marketing authorisation (Autorisation de Mise sur le Marché, AMM) is required for all products as part of marketing authorisation in Morocco.
• The application dossier must comply with the CTD dossier submission in Morocco format and include:
  
  • Quality, safety, and efficacy data
  • Product samples
  • Summary of Product Characteristics (SmPC)
  • Labeling and packaging (in Arabic and French)
  • Evidence of compliance with ICH Q3D for elemental impurities (when applicable)

2. Validation and Stability Batches

• For locally manufactured drugs: Validation and stability studies must be provided for 3 production batches (at least one industrial scale).
• For imported drugs: Validation and stability data for 3 industrial batches are required, unless justified otherwise.

3. Scientific Assessment

• The DMP evaluates the dossier for:
  • Pharmaceutical quality and GMP compliance (on-site inspections possible)
  • Non-clinical and clinical data
  • Benefit-risk assessment

4. Approval and Issuance of MA

• If the drug meets Moroccan Regulatory requirements, a Marketing Authorisation is issued.
• The applicant receives an MA number, permitting import, manufacture, and sale in Morocco.

5. Post-Marketing Surveillance (Pharmacovigilance)

• Ongoing safety monitoring is required after approval.
• The MA holder must submit periodic safety updates (PSURs) and report adverse reactions as per Good Pharmacovigilance Practices (GVP) for Arab Countries.

6. Variations and Modifications

• Any modification of the authorised product (e.g., changes in formulation, indications, labeling) must be declared and may require new data or Ministry approval, depending on the modification type (Type IA/IB/II).

7. Special Pathways

• Morocco may participate in collaborative or reliance pathways under African Medicines Regulatory Harmonization (AMRH) for faster approvals, especially with evidence from recognized Regulatory agencies.

8. Veterinary Medicines

• A similar process applies, governed by Joint Circulars and specific national decrees