Registration with MOHAP and the Emirates Drug Establishment (EDE) is the foundational regulatory gateway to the UAE market. Without it, no medicine can be legally imported, distributed, dispensed, or marketed.
Pharmaceutical product registration with MOHAP and the EDE is our core service, and every other workstream we offer is built around it. It is the step that turns a medicine into a product that can legally reach patients in the UAE.
We run the registration end to end: pre-submission gap analysis, dossier preparation, classification, technical committee submissions, and the variations and renewals that keep the registration current after approval.
A single team across gap analysis, dossier, submissions, and lifecycle.
Pre-submission gap analysis and dossier review to confirm readiness before anything is filed.
Common Technical Document (CTD) and electronic CTD (eCTD) dossier preparation in the required structure.
MOHAP and EDE technical committee submissions, with direct liaison until certificate issuance.
Product classification and the supporting submission prepared as part of the registration file.
Manufacturer site registration, sample and stability data review, and embassy attestation of foreign documents.
Re-registration, variation, and renewal submissions, plus product withdrawal and deregistration when required.
Five stages, run in parallel where they can be, sequential where the regulator requires it.
Review the product, the dossier, and the classification to set the registration route.
Compile the CTD or eCTD dossier, samples, stability data, and attested documents.
File with the MOHAP and EDE technical committees, including manufacturer site registration where required.
Respond to technical committee questions and clarifications through to certificate issuance.
Keep the registration current with variations, renewals, and re-registration over its lifecycle.
Send us the manufacturer details and product specification. We will map the MOHAP and EDE registration pathway, the dossier requirements, and the classification route, and run it end to end through to certificate issuance.
Talk to our regulatory team