Updated for the MOHAP → EDE transition

Pharmaceutical & Medicine Registration in the UAE (EDE)

Marketing authorisation for medicines, biologics and pharmaceutical-pathway products — filed through the Emirates Drug Establishment, with a licensed local applicant route and Arabic labelling handled in-house.

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MOHAP is no longer the drug registration authority

The Emirates Drug Establishment was established under Federal Decree-Law No. 28 of 2023, and Federal Decree-Law No. 38 of 2024 — which came into force on 2 January 2025 and replaced Federal Law No. 8 of 2019 — now governs medical products, the pharmacy profession and pharmaceutical establishments. Effective 29 December 2025, the EDE assumed 44 core services previously held by the Ministry of Health and Prevention — including all marketing authorisations, import and export permits, GMP certification, pharmaceutical facility licensing and pharmacovigilance oversight. No medical product may be circulated, manufactured or sold in the UAE without prior marketing approval from the EDE.

MOHAP has not disappeared. It retains oversight of narcotic-drug services, community and compounding pharmacies, healthcare facility licensing, professional registration and public health, and a further group of services is jointly managed with the EDE, including health advertising approvals. If your last registration went through MOHAP, your next one will not.

Who can actually file: the barrier most manufacturers hit

A foreign manufacturer cannot register a medicine in the UAE directly. The applicant must be a locally licensed pharmaceutical establishment — typically a licensed medical warehouse — and the Marketing Authorization Holder must be registered with the authority before any product file can be opened. A notarised power of attorney from the manufacturer to the local agent, legalised through the UAE consulate in the country of origin, is part of the core submission.

Under Article 22 of the current law, the Marketing Authorization 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's lifecycle in the UAE. Structuring that correctly at the outset avoids re-filing later. This is where most international companies stall. We provide that route through UAE-licensed pharmaceutical partners and qualified pharmacists who hold the necessary licence, while we run the regulatory work — strategy, dossier, labelling and authority correspondence. One point of contact, and a correctly licensed filing entity.

The dossier

EDE dossier requirements follow the ICH-CTD structure. Modules 2 to 5 are largely interchangeable with EU and US submissions for products built to those standards — but Module 1 is country-specific, and it is the single most common source of administrative deficiencies. That is the module that delays files.

Module 1 country-specific administrative documentation
Certificate of Pharmaceutical Product (CPP) in WHO format
Notarised and consulate-legalised power of attorney to the local agent
Valid GMP certification for the manufacturing site
Full quality, safety and efficacy documentation (Modules 2–5)
Bioequivalence data for generics, from a PIC/S-accredited bioanalytical site
Bilingual Arabic–English labelling, artwork and package insert

If your product is already approved elsewhere, do not file from scratch

The EDE operates a verification pathway for products that already hold marketing authorisation in recognised reference jurisdictions — including the EMA, US FDA, MHRA, PMDA and Health Canada. Where the reference approval and dossier are accepted, the review is streamlined to country-specific elements such as labelling, local agent designation and Arabic translation, rather than a full re-evaluation of the global quality, safety and efficacy package. In practice this can compress time to marketing authorisation by roughly 30 to 50 per cent.

A comparable streamlined route exists for generics where the reference product is approved by a recognised authority and bioequivalence data comes from a PIC/S-accredited bioanalytical site. The EDE also runs an accelerated review track for products addressing unmet medical needs and public health priorities — which must be applied for at the pre-submission stage, not after filing.

Choosing the wrong track, or missing the pre-submission window, costs months. We determine the optimal pathway before anything is submitted.

Realistic timelines

Pharmaceutical registration is not a quick process, and any consultant promising otherwise is worth questioning. Generic products typically run 9 to 18 months from submission to marketing authorisation. Innovator products with novel dossiers can run 18 to 30 months. Products qualifying for the verification pathway sit meaningfully below those ranges. We give you a pathway-specific estimate at the outset and tell you which factors in your file are likely to move it.

Tatmeen: approval alone does not let you trade

Under Ministerial Decree No. 73 of 2021, it is prohibited to import or trade any medicinal product in the UAE unless it is linked to the Tatmeen track-and-trace platform, which went live in December 2022. Secondary packaging must carry a GS1 DataMatrix encoding the GTIN, a randomised serial number, batch or lot number and expiry date, and every supply chain participant needs a Global Location Number from GS1 UAE. Marketing Authorization Holders are responsible for commissioning messages to the platform; licensed agents must obtain the import permit and include it.

A registered product that is not correctly serialised and onboarded still cannot legally move. We build this into the launch plan rather than leaving you to discover it at the border.

After approval

Marketing authorisation is the start of an ongoing obligation, not the end of the project. Any change to formulation, source, packaging or safety data requires fresh EDE approval. The authority conducts audits and GMP compliance inspections at manufacturing sites, and non-compliance can lead to fines, product bans, suspension or revocation of the marketing authorisation, or cancellation of a facility licence. Pharmacovigilance reporting runs continuously. We manage variations, renewals and the reporting calendar so nothing lapses.

What we handle

Regulatory strategy and pathway selection before submission
Local applicant and Marketing Authorization Holder route via licensed partners
Module 1 preparation and full CTD dossier compilation
Gap assessment of an existing EU or US dossier against EDE requirements
Legalisation and attestation coordination for POA and CPP
Bilingual Arabic–English labelling, artwork and package inserts
Submission and management of authority queries through to authorisation
Tatmeen serialisation and GS1 onboarding support
Variations, renewals and pharmacovigilance reporting

Beyond product registration

The EDE administers a wider set of approvals than marketing authorisation alone. We handle these as part of the same engagement, so a single team covers your product from first filing through ongoing supply.

Batch release certificates — vaccines, blood factors and plasma derivatives, antivenoms, and tissue or organ products, including OMCL certificates and donor and end-user documentation
Controlled medicine import and export permits — aligned to current narcotics and psychotropic control requirements
Chemical precursor registration — new registration and renewal, plus the monthly consumption reporting that keeps a licence in good standing
Exhibition import permits — bringing medicines or devices in for trade shows and congresses, with invoices, manufacturer documentation and shipment handling
Veterinary pharmaceutical registration — veterinary medical products and veterinary pharmaceutical establishments
Conditional and emergency-use pathways — where a product qualifies outside the standard route

Coverage

Federal EDE registration for the UAE market, with the emirate-level authorities handled where a product classifies outside the pharmaceutical pathway. Taking the same product to Saudi Arabia? That runs under SFDA, and we prepare both gateways from one file rather than starting twice.

How it works

Send your product details, existing approvals and current dossier

We confirm classification and select the optimal pathway, including verification or accelerated eligibility

We arrange the licensed local applicant and MAH route

We compile the CTD dossier, Module 1 and bilingual labelling

We submit, manage authority queries, and support Tatmeen onboarding through to market

Not sure your product is a medicine?

Supplements and vitamins

Without therapeutic claims, most supplements register with Dubai Municipality through Montaji — a shorter, cheaper route than the pharmaceutical pathway.

Supplement Registration →

Cosmetics and personal care

Cosmetics register at emirate level rather than federally. We handle Montaji and the other municipal authorities.

Montaji Registration →

Frequently asked questions

Is MOHAP still the authority for registering medicines in the UAE?

No. The Emirates Drug Establishment took over marketing authorisations, import and export permits, GMP certification and pharmaceutical facility licensing from MOHAP effective 29 December 2025. MOHAP retains narcotic-drug services, pharmacies, and healthcare facility and professional licensing.

Can a foreign manufacturer register a medicine directly?

No. The applicant must be a locally licensed pharmaceutical establishment, and the Marketing Authorization Holder must be registered with the authority. We provide that route through UAE-licensed pharmaceutical partners while handling the regulatory work.

My product is approved by the FDA or EMA. Does that help?

Considerably. Products approved by recognised reference authorities including the EMA, FDA, MHRA, PMDA and Health Canada often qualify for the verification pathway, where review focuses on country-specific elements rather than re-evaluating the full global package — typically compressing timelines by around 30 to 50 per cent.

How long does registration take?

Generics typically run 9 to 18 months and innovator products 18 to 30 months, with verification-pathway products meaningfully faster. We give a pathway-specific estimate once we have seen your file.

What is Tatmeen, and do I need it?

Tatmeen is the UAE national track-and-trace platform. Importing or trading a medicinal product without linking it to Tatmeen is prohibited, and secondary packaging must carry a GS1 DataMatrix with GTIN, serial number, batch and expiry. Registration approval alone is not enough to trade.

Can you register the same product in Saudi Arabia?

Yes. KSA runs under SFDA. We prepare both gateways from a single file rather than duplicating the work.

Bring your product to the UAE market properly

Pathway selected, licensed applicant arranged, dossier built, authorisation managed through to launch.

WhatsApp us about your product Email sales@thecorpbridge.com