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

 

Medicinal Products Regulatory Support in UAE – Overview

The UAE’s pharmaceutical market is booming, valued at USD 4.7B in 2025 and projected to reach USD 8B by 2033. High demand for innovative therapies, biologics, oncology drugs, and chronic disease treatments, combined with advanced healthcare infrastructure and streamlined regulatory pathways, makes the UAE a strategic hub for market entry. EDE (EMIRATES DRUG ESTABLISHMENT), DHA, and DOH oversee approvals, requiring local MAH representation, Products registration, eCTD dossiers, GMP compliance, and price clearance.

Freyr Solutions guides companies through every stage of the regulatory journey, from strategy and dossier preparation to submissions and authority interactions, ensuring efficient, compliant market access.

Medicinal Product Classification in UAE

The EDE (EMIRATES DRUG ESTABLISHMENT) and GCC Drug Regulatory Guidelines classify medicinal products in the UAE primarily based on their intended use, risk level, and potential for misuse or abuse.

This classification determines how products are registered, prescribed, dispensed, and controlled under Federal Law No. (4) of 1983 (Pharmacy Law) and its updates.

Primary Categories (Legally Recognized by EDE & UAE Federal Law)

1. Over the Counter (OTC) Medicines
Medicines safe for self-medication; available without a prescription.
Example: Paracetamol, mild topical creams.
2. Pharmacist-Only Medicines (PHOM)
Dispensed only by a licensed pharmacist; no prescription required, but pharmacist consultation is mandatory.
Example: Certain cough syrups, antihistamines.
3. Prescription-Only Medicines (POM)
Require a valid prescription from a licensed medical practitioner.
Example: Antibiotics, antihypertensives, insulin.
4. Semi-Controlled Drugs (SCD)
Medicines that are not narcotics or psychotropics but still require special monitoring due to possible misuse or dependence.
Example: Certain sleep aids or pain medications.
5. Controlled Drugs (CD)
Contain substances under strict regulatory control due to their abuse potential, governed by Federal Law No. 14 of 1995 and Ministerial Decree No. 888 of 2016.
Includes: Psychotropic substances and narcotics under Schedule IV and V.
6. Narcotic Drugs
Highest level of control — narcotics and psychotropics that require special import/export permits, storage, and dispensing records.
Example: Morphine, Fentanyl.

Additional Product Categories (Per GCC & EDE Guidelines)

  • Biological / Biotechnological Products – Vaccines, blood products, monoclonal antibodies, biosimilars.
  • Herbal Medicinal Products – Contain active ingredients derived solely from plants.
  • Traditional / Complementary Medicines – Includes Ayurveda, Homeopathy, Unani, and other non-conventional systems.
  • Combination Products – Combine two or more regulated components (e.g., drug–device combinations, vaccine–adjuvant combos).
  • Veterinary Medicines – Formulated exclusively for animal use.
  • Health Products / Supplements – Include vitamins, minerals, and nutraceuticals that promote health but are not classified as medicines.

 

Medicinal Product Drug Registration & Approval

The EDE (EMIRATES DRUG ESTABLISHMENT) governs the registration, pricing, and marketing authorization of all medicinal and pharmaceutical products in the UAE. Its objective is to ensure that only safe, effective, and high-quality medicines reach the market whether locally manufactured or imported.

Key Steps in the Process

1. Classification / Pre-assessment
Before submitting a full registration, companies often need a product classification letter from EDE (EMIRATES DRUG ESTABLISHMENT) . This determines whether the product is a full “medicine”, or a “general sale / limited medicinal use” product (OTC, supplements, medical cosmetics, etc.) and identifies the regulatory pathway.
2. MAH & Local Agent / Warehouse Licensing
The Marketing Authorization Holder (MAH), whether local or foreign via a UAE agent, must be registered/licensed with EDE (EMIRATES DRUG ESTABLISHMENT) . Also, the importing / distribution must be via EDE (EMIRATES DRUG ESTABLISHMENT) -licensed medical warehouse.
3. Submission of Dossier
The applicant submits a dossier (in many cases in eCTD format) which includes modules covering quality, safety, and efficacy. Required documents typically include: GMP certificate of manufacturer, certificate of free sale or Certificate of Pharmaceutical Product (CPP), full formulation detail, manufacturing site details, labelling and leaflet artwork, and often Halal certificate for relevant products.
4. Technical Review & Committee Deliberation
EDE (EMIRATES DRUG ESTABLISHMENT) assigns a technical committee to review the dossier. If acceptable, the dossier is forwarded to a ministerial / higher committee for final approval. Additional lab analysis, sample testing, or clarifications may be requested.
5. Issuance of Registration Certificate
Once approved, EDE (EMIRATES DRUG ESTABLISHMENT) issues a registration certificate. For general sale products (limited medicinal use) the certificate is valid for five years. Locally manufactured product certificates (pharmaceutical/manufacturer) often have a one-year validity for certain certificates like pharmaceutical site licensing (manufacturing site registration certificate validity is 5 years).
6. Renewal & Amendments
Registrations must be renewed (every 5 years for general sale / product registration). Any minor or major changes (formulation, manufacturing site, labelling, etc.) need submission of amendments or variations for approval.
7. Post-Approval / Obligations
After registration, EDE (EMIRATES DRUG ESTABLISHMENT) requires compliance with quality (GMP), batch release, labelling standards, pharmacovigilance (safety reporting), possibly periodic re-inspection, and ensuring that any changes are pre-approved.

Specific Requirements & Timelines (examples)

  • For general sale / OTC / Medical device, the process is around 45 working days for registration. Application fee around AED 100, registration fee AED 5,000.
  • Renewal of such registrations also has defined timelines (15 working days for renewal of general sale product) and fees is AED 2500
  • Manufacturer site registration or renewal takes 2-4 weeks; fees are higher (e.g. AED 10,000 for manufacturer registration renewal) in some cases.
  • For Professional medical devices we provide the classification service, the timeline is 10 working days, and the Government fee is AED 500
  • Health technology registration for the Software medical devices with DOH (Department of Health)

 

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Freyr Expertise – UAE Regulatory & Strategic Support  

Freyr provides comprehensive Regulatory services tailored to the UAE:

Regulatory Consulting & Strategy

  • Regulatory strategy aligned with EDE (EMIRATES DRUG ESTABLISHMENT) , GCC, and ICH guidelines.
  • Gap analysis and remediation planning for generics and new drug applications.
  • Regulatory intelligence and market access pathway advisory.

Dossier & Submission Management

  • Dossier compilation and publishing (eCTD/non-eCTD) as per EDE (EMIRATES DRUG ESTABLISHMENT) requirements.
  • Submission planning, review, and finalization with stakeholder alignment.
  • Health authority query management and follow-up until approval.

Local Representation & HA Liaison

  • Authorized local agent services for foreign manufacturers.
  • Regulatory communication and coordination with EDE (EMIRATES DRUG ESTABLISHMENT) for classification, registration, and pricing.
  • Support for special imports and continuous submission tracking.

Registration, Compliance & Maintenance

  • Product registration, renewals, and variations management.
  • Labelling, artwork, and Ad-Promo compliance review.
  • CMC, clinical, and non-clinical documentation support.
  • Pharmacovigilance, audits, and regulatory data management.

GMP & Site Support

  • Assistance with GMP documentation, site registration, and inspections.
  • Local audit readiness and compliance support.

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