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. The Regulatory framework covers drug registration, 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, thanks to growing local manufacturing capacity, Regulatory reforms, and a stable Regulatory 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 registration and approval process for pharmaceutical drugs in Morocco is regulated by the Ministry of Health’s Directorate of Medicines and Pharmacy (DMP). Below is a summary of the key steps and Regulatory requirements:

1. Submission of Marketing Authorisation (MA) Application

• Marketing authorisation (Autorisation de Mise sur le Marché, AMM) is required for all human or veterinary pharmaceutical products.
• The application dossier must comply with the Common Technical Document (CTD) 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