If your company registers medicines, medical devices, biopharmaceutical products or healthcare products in the UAE, the ground shifted under you on 2 January 2025. That is when the Ministry of Health and Prevention (MOHAP) began transferring these registration functions to the Emirates Drug Establishment (EDE), a federal authority created under Federal Decree-Law No. 28 of 2023 and given its expanded mandate under Federal Decree-Law No. 38 of 2024. The handover completed at the end of December 2025, when the EDE assumed 44 core services from MOHAP. Here is what actually changed, and what to do about it.
What the EDE now controls
The EDE is now the authority for marketing authorisation of medicines and biopharmaceutical products, covering new applications, renewals and amendments. It also handles medical device registration and classification, batch release certificates for vaccines, blood factors, plasma derivatives, antivenoms and tissue or organ products, GMP compliance certificates and manufacturer registration, import and export permits including controlled medicines and chemical precursors, and pharmacovigilance oversight and post-market surveillance.
MOHAP has not disappeared. It retains jurisdiction over community and compounding pharmacies and a set of narcotic drug controls, and the Department of Health in Abu Dhabi still maintains its own formulary system for the emirate. So this is not a single clean handover. It is a redistribution, and knowing which authority governs which part of your product lifecycle is now part of the job.
The practical changes companies are running into
A new portal
Applications now run through the EDE portal rather than the previous MOHAP system. Companies with existing MOHAP registrations have had to re-orient to new screens, new document upload requirements and, in some cases, new reference numbers. Maintaining portal access matters for renewals, vigilance reporting and import permits alike, not just for first-time filings.
Timelines that do not match the published estimate
The EDE publishes a 45-working-day technical review target. In practice, first-time medical device registrations, particularly in the higher risk classes, commonly run two to eight months once deficiency letters and resubmission cycles are accounted for. Pharmaceutical registration runs longer still: roughly nine to eighteen months for generics and eighteen to thirty months for innovator products with novel dossiers. Companies that plan around the published figure consistently miss their own launch dates.
Multi-agent representation is now structural
Under Article 22 of the current law, the marketing authorisation holder must appoint at least two importers and one or more distributors, and nominate one designated pharmaceutical establishment as the main entity responsible for regulatory affairs, pharmacovigilance and quality management across the product lifecycle. This is a meaningful shift away from the single exclusive agent model. Changing representatives after the fact is administratively heavy, so it is worth treating as a strategic decision rather than paperwork.
Arabic documentation, front and centre
Labelling and instructions for use must carry Arabic alongside English. This has always been a requirement in some form, but it is now among the most common reasons applications stall, because companies leave translation until late in the process. Preparing Arabic in parallel with English from the start removes an entire category of delay.
Real exposure for non-compliance
Marketing authorisation holders that do not maintain the required quality assurance, traceability and pharmacovigilance systems face administrative penalties, suspension or revocation of the marketing authorisation, product bans and cancellation of facility licences. The EDE also conducts audits and GMP inspections at manufacturing sites. This is not a filing exercise that ends when the certificate arrives.
Separately, no medical product can legally move without being linked to the Tatmeen track-and-trace platform, with GS1 serialisation on secondary packaging. Approval alone does not permit you to trade.
If you are already MOHAP-registered
Existing registrations do not simply disappear, but they are being migrated and in many cases require active renewal or re-filing under current EDE rules, particularly around representation structure and documentation. The safest approach is a status review: confirm what the EDE actually holds on file for your product today, rather than assuming an old MOHAP registration carries forward unchanged.
If you are entering the UAE market for the first time
Start earlier than you think you need to. Given realistic review timelines, begin the process around twelve months before intended market entry rather than six. Prepare Arabic documentation in parallel with English from day one. Treat representative selection as a distribution decision with regulatory consequences, not an afterthought. And check early whether your product qualifies for the verification pathway: products already approved by recognised reference authorities such as the EMA, FDA, MHRA, PMDA or Health Canada can see review compressed substantially, because the assessment focuses on country-specific elements rather than re-evaluating the full global package.
Where CorpBridge fits in
We run the same regulatory playbook for EDE registration that we have used for SFDA and MOIAT product registration for years: gap analysis against your current status, full dossier preparation including Arabic labelling and legalisation of foreign documents, portal submission and liaison through the technical review, and ongoing renewal and post-market compliance management. Pharmaceutical files are handled with UAE-licensed pharmaceutical partners, so the applicant and marketing authorisation holder requirements are met properly.
If you are unsure whether your current registration is still valid under the EDE, or you are planning a UAE launch and want a realistic timeline rather than the published one, talk to our regulatory team.