QATAR

QATAR

All medicinal products and medical devices must be registered/authorised by the Ministry of Public Health (MoPH) before import, sale or distribution in Qatar. Applications are submitted through MoPH electronic services (PDCD/Registration portals) and reviewed by the Pharmacy & Drug Control Department.

1. Small-Molecule Drugs (Innovator & Generics)

Covers: Oral solids, injections, topical drugs, and generics.

Key Regulatory Requirements

• Marketing Authorization (MA) via local authorised agent/MAH
• CTD dossier (Modules 1–5) with GMP certificate, batch release & stability data
• Legalized GMP certificate from country of origin
• Power of Attorney, local agent commercial licence, FSC/CPP

Typical Timeline: 2–12 months (faster for well-documented generics)

Post-Approval: Batch release (if required), pharmacovigilance (PSUR/PBRER & ADR reporting), compliant labelling

2. Biologics, Vaccines & Biosimilars

Covers: Recombinant proteins, mAbs, vaccines, plasma-derived products, biosimilars.

Major Requirements

• Full quality, non-clinical & clinical data + comparability studies (for biosimilars)
• MoPH “Guidelines for Registration of Biological Products” applied in practice
• Validated GMP + established pharmacovigilance system
• Biosimilars: rigorous comparability package aligned with WHO/ICH

Typical Timeline: 6–18+ months (multiple review rounds common)

Post-Approval: Active surveillance, rapid serious signal reporting, mandatory PSUR/PBRER

3. Controlled, Herbal & Nutraceutical Products

• Controlled/narcotics: special permits & strict import/storage controls
• Herbal/nutraceutical/medicated cosmetics: composition, COA, FSC, safety data
• Timeline varies: simple OTCs faster; high-risk categories need extra approvals

4. Medical Devices & IVDs

Classification: Follows CE/FDA risk-based model (Class I → III)

• Mandatory local authorised representative
• Technical file: classification, clinical evidence (if required), ISO 13485, CE/FDA certs
• Device listing + per-shipment import permit

Typical Timelines:
• Class I: few weeks to months
• Class II/III & IVDs: 3–9+ months

Post-Market: Device vigilance, incident reporting, possible corrective actions

Common Practical Steps (All Products)

1. Appoint a local authorised agent/MAH (mandatory)
2. Prepare CTD or device technical file with legalized GMP, FSC/CPP, labels
3. Submit via MoPH e-services / PDCD portal
4. Respond quickly to queries — fastest approvals with complete first submission
5. Establish PV & post-market obligations (ADR, PSUR, vigilance)