Medicinal Product 
End-to-end support from experienced Regulatory experts.

Medicinal Products Regulatory Support in Qatar - Overview

Qatar’s pharmaceutical market is a key part of the rapidly expanding GCC healthcare landscape, governed by robust Regulatory frameworks aligned with GCC-DR, ICH, and WHO guidelines. The Pharmacy & Drug Control Department (PDCD) under MoPH ensures that all medicinal products meet established standards of quality, safety, and efficacy prior to approval.

To obtain Marketing Authorization in Qatar, companies must submit GCC-compliant CTD dossiers, provide valid GMP certification, secure pricing approvals, and ensure Arabic labeling compliance.

We support pharmaceutical manufacturers and importers across the entire Regulatory pathway—ensuring dossier accuracy, alignment with MoPH/PDCD requirements, and timely approvals for market entry in Qatar.

Medicinal Product Classification in Qatar

Under Qatar MoPH and GCC-DR regulations, medicinal products are classified as:

• Prescription Medicines (Rx): Require physician prescription and PDCD approval.
• OTC Medicines: Must demonstrate established safety profiles and comply with defined approval requirements.
• Biologicals & Biosimilars: Subject to detailed comparability, nonclinical, and clinical evaluation.
• Controlled Medicines: Regulated under narcotic and psychotropic control laws; special licenses are required.
• Herbal & Natural Products: Assessed based on composition, claims, and safety; full registration may apply.

All medicinal products must be registered with MoPH/PDCD before marketing, importation, or distribution in Qatar. Sale of unregistered products is strictly prohibited.

Medicinal Product Registration & Approval Process in Qatar

Regulatory Authority: Ministry of Public Health (MoPH) – Pharmacy & Drug Control Department (PDCD)
Legislation: GCC-DR Guidelines, Qatar MoPH Circulars, Pharmacovigilance Regulations

Key Steps 

1. Licensing

• Foreign manufacturers must appoint a local Marketing Authorization Holder (MAH) licensed in Qatar.
• Manufacturing facilities must hold GMP certification acceptable to GCC authorities.

2. Dossier Submission

• Submission in CTD format (Modules 1–5) aligned with GCC requirements.
• Includes CPP, GMP certificates, quality documentation, stability data, product samples, and Arabic labeling.

3. Scientific Evaluation

• PDCD conducts in-depth assessment of quality, safety, and efficacy.
• GCC or reliance-based evaluations may apply depending on product category.

4. Pricing Approval

• Drug pricing is regulated by MoPH pricing committees.
• Pricing approval is mandatory prior to commercialization.

5. Marketing Authorization Grant

• Marketing Authorization is issued upon successful evaluation, in line with Qatar MoPH regulations.

Post-Authorization Requirements 

• Mandatory Arabic labeling compliance.
• Import permits and batch release approvals for each shipment.
• Local pharmacovigilance system with a designated Qualified Person (QPPV).

Specific Requirements by Product Type 

• Generics: Bioequivalence studies required; GCC guidance applies.
• Biologics/Biosimilars: Must comply with WHO/ICH/GCC comparability frameworks.
• Vaccines: Subject to additional testing and batch release oversight.
• OTC Products: Simplified pathway with strict safety, labeling, and advertising controls.

Post-Approval & Pharmacovigilance 

Approved medicinal products in Qatar are subject to continuous MoPH oversight:

• Renewals: Periodic submission of updated quality and safety data.
• Variations: Prior approval required for changes in formulation, manufacturing, packaging, or labeling.

Pharmacovigilance Obligations:

• Local QPPV appointment
• ADR reporting per Qatar PV guidelines
• Market surveillance, inspections, recalls, and safety communications

We provide comprehensive lifecycle support to maintain compliance and ensure uninterrupted market presence in Qatar.