Emirati law recognises marketing approvals from "reference countries" and uses them in pricing. It does not say which countries those are, and no list appears on any UAE government site we could reach. Whether the MHRA counts here is the one question about this market we cannot answer from public sources — so we say so.
The Emirates Drug Establishment was created in September 2023 and succeeded the Ministry of Health in all rights and obligations for medical products. The governing decree-law came into force on 2 January 2025 and makes the position absolute: nothing may be imported, distributed, possessed, sold, displayed, re-marketed, used or manufactured in the State without a marketing approval from EDE.
The applicant must be an Emirati-licensed establishment — a medical warehouse, a local manufacturer, or a marketing office — pre-registered with EDE as the marketing authorisation holder. A foreign company cannot file for itself.
The obligation that made the Emirati device page notorious applies here too: the holder of the marketing right must appoint at least two licensed importers for the same product, plus one or more distributors, and must notify EDE which one is the main establishment carrying the licensing work, the pharmacovigilance and the lifecycle. One application is filed regardless of how many establishments are appointed, and all appointed establishments are required to actually import during the calendar year.
If you have been offered an exclusive Emirati distribution agreement for a pharmaceutical product, that last clause is the one to read twice.
Services moved from the Ministry to EDE in tranches rather than overnight — marketing authorisations, import and export approvals, factory and warehouse licensing, good-practice certificates, registration, pricing, renewal and pharmacovigilance are now EDE's. Community and compounding pharmacies stayed with the Ministry.
This is the only page on this site where we cannot answer that question, and the reason is worth stating precisely.
The decree-law's first article defines reference countries as those whose marketing approvals for the medical product have been recognised. Article 6 uses them twice — the assessment may consider a product's compliance with the marketing approvals issued for it by the reference countries, and a good manufacturing practice certificate may come from EDE, from the authority in the state of origin, or from any of the reference bodies accredited by EDE.
So both a reference-country list and an accredited-body list exist as operative legal concepts. Neither is published. We searched the federal legislation portal, EDE's own legislations page and the Ministry's site. The executive regulations that the decree-law contemplates have not appeared. EDE's pricing rules repeatedly invoke "the list of countries with registration and pricing reference status" without setting it out.
What is documented, and what we would do about it. Registration status in the country of origin is a mandatory dossier field where the product does not belong to the marketing authorisation holder in the UAE, with the authority, the holder, the approval date and the marketing date. A certificate of pharmaceutical product is required, original and legalised at the UAE embassy — Gulf-origin documents are exempt from that legalisation. Beyond that, the honest course is a written enquiry to EDE before you plan around an answer. We have seen the MHRA asserted as an Emirati reference authority on a law firm's page; the page we retrieved was internally inconsistent and attributed the same decision to a different country, and we will not repeat it.
One thing does stand in your favour and is properly sourced: the MHRA became a full WHO Listed Authority for medicines and vaccines in June 2025. Where a regulator's criteria are unpublished, that is the strongest credential a UK applicant can put on the table.
The marketing authorisation holder must be registered before any service can be used. Everything runs through EDE's portal with national digital identity authentication and mandatory electronic payment.
Us, with the partnerA legalised current GMP certificate from the competent authority in the country of origin, a manufacturing licence legalised and attested at the UAE embassy, a site master file, the product list and a company profile. Approval follows the conditions of the Higher Committee for Registration of Human Medicines. Valid five years; renewable when six months or less remain.
You, assembled by usElectronic common technical document format, through the portal. The application types offered are conventional product, biological, general sales list, natural-source medicine and device — with no separate generic, biosimilar, fast-track or priority category published.
Holder, managed by usMarketing a product that holds an approval still requires a price fixed under rules set by EDE's board. The submission carries reference prices per pack size — ex-factory, wholesale and public, with the source publication named — and Gulf and European comparisons.
Us, with youStatute requires at least two, and requires them all to import during the year. Each shipment needs a permit charged at one per cent of the invoice value.
Shared — we run the calendarWatch the applicant-side clocks. An application is treated as rejected if you do not return a corrected file within sixty days. A laboratory analysis result is accepted automatically if you do not act within sixty working days. A re-pricing decision you neither accept nor appeal within sixty days rejects the application. None of these is the regulator being difficult; all of them are silent deadlines that a distributor managing your file may not tell you about.
Unlike the fee position in Egypt or Nigeria, this one is clean: a Cabinet resolution of April 2025 sets the figures and EDE mirrors them on every service page.
| Item | Fee, AED | Published period |
|---|---|---|
| Marketing authorisation — conventional or biological medicine | 7,000 | 45 working days |
| Marketing authorisation — general sales list or natural source | 5,000 | — |
| Renewal — conventional or biological | 3,500 | 5 working days |
| Renewal — general sales list or natural source | 2,500 | — |
| Variation | 1,000 | 22 working days |
| Laboratory analysis | 3,000 | — |
| Pharmacovigilance plan evaluation | 1,000 | — |
| Pricing certificate, single product | 500 | 90 working days |
| Re-pricing, single product | 1,000 + 500 | 90 working days |
| Manufacturing site registration or renewal | 10,000 | 2–4 weeks |
| EDE good manufacturing practice certificate | 2,000 per line, per year | 3–5 working days |
| Import permit | 1% of invoice value minimum 200, per invoice | 3 working days |
Every service also carries a AED 100 application fee. From the Cabinet resolution on EDE service fees, in force 29 April 2025, mirrored on EDE's service pages. A marketing authorisation runs five years; for a product registered through the Gulf centralised procedure the five years run from the Gulf certificate date. Renewal is filed when the pack has expired or expires within three months.
Pricing is a separate application with its own ninety working day period, and marketing is not permitted until a price exists. Site registration, where your factory is not already on EDE's books, is another two to four weeks and must precede the product. Add the embassy legalisation queue for the certificate of pharmaceutical product and the manufacturing licence, which is the step most often underestimated. A UK company that budgets forty-five working days and tells its board that is the timeline will be explaining a slip within the quarter.
The decree-law says the price is determined under general rules issued by a decision of EDE's board. That board decision is not on EDE's legislations page, which currently carries the federal instruments, a pharmacovigilance guideline and the national essential medicines list, and nothing on pricing methodology or reference countries.
What the service pages do document is the submission: a pricing certificate from the country of origin, attested and legalised at the UAE embassy; a justification statement; reference prices from Gulf and European countries for comparison; and, per pack size, the price type, country, ex-factory, wholesale and public prices, the currency for each, and the reference publication they came from.
The United Kingdom does appear in the Emirati pricing materials — but as a price source, one of the reference publications a submission may cite, alongside the other standard price books. That is not the same thing as being in the benchmark basket, and we are not going to present it as if it were.
For contrast. Saudi Arabia publishes its basket, all sixteen countries including the United Kingdom, and publishes the exact reductions that follow a generic or biosimilar entry. Two Gulf markets, the same product, and in one of them you can model the price and in the other you cannot. That asymmetry belongs in your sequencing decision.
Defined in statute, used in pricing, published nowhere. Whether the United Kingdom is on it cannot be established from public sources. This is the single most important open question about this market.
The decree-law permits a certificate from a body EDE accredits. That list is unpublished too, so whether an MHRA or EU certificate removes the need for anything further is unresolved.
The decree-law delegates the conditions for marketing approval to executive regulations. No Cabinet decision issuing them has appeared. The executive regulations of the repealed 2019 law are still flagged active on the legislation portal, which suggests they continue to apply, but no Emirati source says so.
The board decision containing the general pricing rules is not published. We found no rule mandating periodic re-pricing, and we could not rule one out.
No EDE page says it does. None says an EU or MHRA certificate is accepted in lieu. Both silences matter to a launch budget.
The final articles of the decree-law were truncated in every retrieval we attempted, so the grace period for registrations issued by the Ministry before January 2025 is unverified.
The legislation portal states that its English texts are informative and that the Arabic originals govern. Everything above is from the English renderings; the Arabic is checked before it enters a client document.
The Emirati device page covers the same regulator's rules for medical devices — where the document list names EC, 510(k) and PMA, does not name UKCA, and the review period is forty-five working days for a device rather than a medicine. The two-importer rule is common to both, and it is the one structural fact a company selling both products must design around once rather than twice.
The medical devices page for the UAE → · Saudi Arabia, for medicines →
Saudi Arabia publishes its pathways, its basket and its price reductions. The UAE publishes its fees and its clocks and withholds its lists. Send us the product and we will tell you which to do first, and what to ask EDE in writing before you commit.
Or reach us directly — mail@bcabusiness.co.uk · +44 7342 901002 · WhatsApp
Re-checked quarterly, and immediately if EDE publishes its reference-country list, its accredited bodies or the executive regulations. Any of the three would change this page substantially, and the first would change the answer to the question most UK companies ask first.