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Regulatory Journey
The Path to Market Approval
A structured, step-by-step approach to regulatory compliance and successful UAE market entry.
On the record- File
- No. 61109Licensed UAE establishment
- Stages
- 6Structured Process
Overview
Structured Regulatory Process
Our six-stage regulatory journey provides clarity, transparency, and professional guidance at every step, from initial documentation review through to market approval.
Initial assessment and proposal, within one working day. After receiving your enquiry and available product information, we conduct an initial assessment to identify the likely regulatory route, outline the required documents and send a proposal covering the scope of services, fees and estimated timelines within one working day. The detailed registration process begins after acceptance of the proposal and receipt of the required documents.
- 01Documentation Review
- 02Compliance Assessment
- 03Regulatory Preparation
- 04Authority Submission
- 05Authority Review & Follow-Up
- 06Approval & Next Steps
Six Stages
The stage in viewDocumentation Review
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Our review and preparation, typically 3 to 5 working days
01Documentation Review
Review the supplied product information, artwork and supporting certificates to confirm completeness and identify missing documents.
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02
Compliance Assessment
Assess intended use, ingredients or technical specifications, claims and labelling against applicable requirements. Identify compliance gaps and determine whether authority classification is required.
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03
Regulatory Preparation
Compile the application and coordinate with the client or manufacturer to address identified gaps and finalise the submission documents.
Detailed review and preparation typically take 3 to 5 working days after complete documentation is received. Complex EDE applications or larger product portfolios may require additional time, which we confirm following the initial assessment.
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04
Authority Submission: within one working day
Once the application is finalised, required client confirmations are received and applicable fees are paid, we submit it to the relevant authority within one working day and confirm the application reference.
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05
Authority Review & Follow-Up
Application monitoring, progress updates and coordination of responses to authority comments or additional requirements.
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06
Approval & Next Steps
Following authority approval, receipt of registration documentation and guidance on applicable import, shipment clearance and ongoing compliance requirements.
Expected Duration
Expected Timelines by Route
- Dubai Municipality (Montaji)
- Approximately 4 to 8 weeksCosmetic and personal-care registration, following submission of a complete application. Indicative estimate, subject to product eligibility and authority review.
- Emirates Drug Establishment (EDE)
- 10 working daysProduct classification, where required
- Manufacturer registration
- Approximately 4 to 6 weeksEDE manufacturer registration, where required
- Marketing authorisation
- 45 working daysEDE marketing authorization for a medical device, drug or biopharmaceutical product
Authority processing is separate from our assessment, preparation and submission periods. Timelines relate to individual service stages and may be extended by additional documentation, testing or authority queries. Applicable prerequisites, including manufacturer and Marketing Authorization Holder registration, must be completed before product registration where required. Existing valid registrations may reduce the steps needed. These durations do not represent a guaranteed overall completion date.
Ready to Begin Your Regulatory Journey?
Share your product details to receive an initial assessment and proposal within one working day.
- Address
- Abdulla Jaber Building, Warsan Fourth, Dubai, UAE
- hello@savoydrugstore.ae
- Office Hours
- Monday–Friday9:00 AM–5:00 PM