United Arab Emirates Pharmaceutical Licensing

This record covers only entry-point compliance for retail pharmacy, wholesale medical warehouses, and manufacturing of human medical products in the UAE. General pharmacies are licensed by MOHAP or the local health authority with jurisdiction; warehouses/stores, factories, and contract manufacturing establishments are licensed by EDE. A general trading or industrial commercial licence is only one component and cannot replace a medicinal product facility licence.

Federal Law No. 38 of 2024 leaves arrangements for foreign/national capital to the local company authority in the relevant emirate, in conjunction with EDE. It may prescribe a national capital percentage or allow full foreign ownership. Free zones are also subject to statutory exceptions. Accordingly, follow the current written position of the authority responsible for the intended emirate, business activity, and commercial licence; a uniform ownership percentage, company form, or capital amount cannot be promised.

— Retail: the general pharmacy facility licence is separate from the responsible pharmacist's individual licence.

— Wholesale: EDE medical warehouse licence, good storage and distribution practices, and authorised activity scope.

EDE is central to facility licensing, good-practice certificates, product marketing authorisations, and import/export/re-export approvals for warehouses, stores, factories, and contract manufacturing establishments. MOHAP's notice expressly states that licensing, renewal, amendment, and cancellation services for medicinal product facilities, including factories and warehouses/stores, have transferred to EDE, while community and compounding pharmacies remain within the MOHAP system.

However, the UAE does not have a single federal front end covering all retail matters. The Federal Law states that general and compounding pharmacies are handled by MOHAP or the local health authority with jurisdiction; local health authorities may impose additional technical and health conditions within their jurisdictions. Local procedures in Dubai, Abu Dhabi, and other emirates should be verified for the specific location; one emirate's example must not be treated as representative of the whole country.

— EDE: warehouses, factories, product marketing authorisations, GMP/GSDP, and cross-border licences.

— MOHAP/local health authority with jurisdiction: general and compounding pharmacies, and related pharmaceutical professional practice matters.

A general pharmacy is a medicinal product facility that stores, prepares, dispenses, displays, or sells medical products directly to the public. Before opening, it must obtain a licence from MOHAP or the local health authority with jurisdiction, and its technical management must be undertaken by a licensed, responsible, full-time pharmacist. A compounding pharmacy is not an automatic extension of an ordinary pharmacy: the Federal Law requires it to have a separate valid EDE good compounding practices certificate, a full-time responsible compounding pharmacist, and technical/health conditions.

MOHAP's current service page for establishing a community or compounding pharmacy lists documents in stages: owner identification and site plans/photos; municipal-certified land-use documents, lease, and trade-name reservation; and commercial licence, responsible pharmacist's licence, Civil Defence compliance certificate, and list of partners. Applicability must be confirmed with the authority for the intended location; the service page cannot replace local requests for additional documents.

— First determine whether the proposed business is a general pharmacy, compounding pharmacy, hospital-affiliated pharmacy, or another project; this record does not treat them as the same licence type.

— Obtain approval from MOHAP or the local health authority with jurisdiction before relocating a general pharmacy, changing plans, or transferring ownership to a third party.

The primary facility licensing route for pharmaceutical wholesale is the EDE medical warehouse licence. The law defines a medical warehouse as a medicinal product facility licensed to store and hold medical products, medicinal raw materials, and supplies; it may conduct import, distribution, re-export, or other activities as authorised under the implementing regulations and for the relevant location. A warehouse must not undertake unauthorised import, export, storage, distribution, or sale by relying on a general commercial licence or its status as a mere storage facility.

EDE's warehouse service distinguishes import/distribution warehouses from re-export warehouses and uses the following steps: electronic owner approval, initial inspection, initial approval, documents from related authorities, pharmacist licence, final inspection, and final approval. Completing an application does not authorise all products or all cross-border flows; the scope of import/export and the procedures for each shipment must still be handled according to the product and licence scope.

— Medical warehouse: EDE licence category for import or distribution.

— Re-export warehouse: separate category intended for re-export of medical products and medicinal products.

A medicinal product factory or contract manufacturing establishment must obtain an EDE licence and a valid GMP certificate before commencing operations. If it also engages in import, export, marketing, or distribution within the country, the law requires it to obtain the corresponding EDE licences separately. Locally manufactured products intended for circulation within the UAE must also obtain EDE product marketing authorisation; the factory licence does not replace product-level approval.

EDE's new establishment service uses four stages: initial approval, engineering and construction/installation, GMP inspection, and final approval. The engineering stage involves engineering drawings approved by the EDE technical committee, documents relating to industry/utilities/municipality/environment, and production-line and quality-control laboratory equipment information. The final stage requires licence and appointment documents for the production, quality assurance, and quality control managers, a staff duty list, and a Civil Defence certificate.

— The manufacturing scope, production lines, dosage forms/devices, site, equipment, and quality-control arrangements should match the application and final certificate.

— Without EDE approval, a manufacturing licence must not be interpreted as blanket authorisation for product registration, import, export, marketing, or distribution.

Enterprise facility licensing and individual professional licensing must be handled separately. The Federal Law provides that MOHAP is responsible for licensing pharmaceutical professionals practising in EDE-licensed medicinal product facilities and biobanks; MOHAP or the local health authority with jurisdiction handles applications and renewals for pharmaceutical professional practice within its respective jurisdiction. A responsible, licensed, full-time pharmacist is central to the technical management of both general and compounding pharmacies.

Warehouses/stores generally must be managed by a responsible, licensed, full-time pharmacist; a statutory exception for engineers/health professionals applies only to medical-device activities. EDE's new manufacturing establishment and renewal services require valid licences, appointment documents, and duty materials for the production manager, quality assurance manager, and quality control manager. The education, experience, assessment, police clearance, employment offer, and labour documents listed in MOHAP's individual pharmacist service are requirements for an individual licence, not the enterprise licence itself.

— General pharmacy: responsible, full-time, licensed pharmacist.

— Manufacturing: evidence of licences, appointments, and duties for key production, quality assurance, and quality control positions.

Pharmacy premises must meet the Federal implementing regulations and any additional technical/health requirements of the local health authority. MOHAP's establishment service lists architectural plans approved by an engineering consultant, site photographs, municipal-certified documents, lease, commercial licence, and Civil Defence documents as application materials, but does not specify uniform floor-area or distance-from-other-pharmacies figures that can safely be applied across all emirates.

A pharmaceutical warehouse must first obtain an EDE Good Storage and Distribution Practice certificate. Inspections are supported by a site layout plan, lease, Civil Defence certificate, commercial licence and details of the responsible pharmacist. Factory engineering drawings must be approved by the EDE Technical Committee and cover production, packaging, sterilisation and quality-control equipment, together with supporting environmental, industrial, municipal and Civil Defence documents.

— Retail: Confirm the plans, fire-safety, health and local supplementary requirements for the Emirate in which the premises are to be located.

— Manufacturing: Engineering, logistics, personnel flow, equipment and laboratory arrangements should first be aligned with GMP and the approved scope.

A retail pharmacy should first determine whether the MOHAP or relevant local health authority route applies in the Emirate where it is to be located. The staged information on MOHAP’s community/compounding pharmacy service page shows that owner details and initial inspection, preliminary approval of the address/lease/trade name, and final inspection and approval involving the commercial licence/responsible pharmacist/Civil Defence are separate stages. Local authorities may require additional technical documents.

The EDE warehouse route consists of an application through UAE PASS, electronic owner approval, initial inspection, preliminary approval, procedures with the relevant authorities, pharmacist licensing, final inspection and final approval. For manufacturing, after preliminary approval the process proceeds to engineering drawing approval, construction and fit-out, GMP inspection and qualification of key personnel, followed by submission for the final licence. Product marketing, import/export and controlled-drug applications should be listed separately in the project documentation checklist.

— First determine the facility category, product category, scope of activities, address and receiving Emirate.

— After submission, complete inspections, provide supplementary documents and remedy deficiencies as required by the competent authority; do not commence operations until the requirements have been met.

The official service pages reviewed support some specific fees, but those fees should be applied only to the service category, application stage and complete-documentation conditions stated. The MOHAP community/compounding pharmacy page lists AED 1,000 for the initial inspection, AED 1,000 for preliminary approval, AED 1,000 for the final inspection and AED 7,500 for the final licence, and indicates 3 working days. The EDE warehouse page lists an AED 100 application fee, AED 1,000 for each initial/final inspection, AED 7,500 for a pharmaceutical warehouse final licence and AED 10,000 for a re-export warehouse licence; it also states 3 working days for each stage of a complete application.

The new manufacturing facility service lists an AED 100 application fee, AED 3,000 for each final inspection, AED 2,000 for engineering drawing approval, AED 2,000 for a GMP compliance certificate and AED 50,000 for the final licence. The service time for each step starts upon receipt of the application, inspection report or final requirement, as applicable. The manufacturing renewal page lists an AED 100 application fee and an AED 25,000 final renewal fee, and indicates 3 working days. Federal law provides that the relevant facility licence is valid for at least 1 year and may be renewed; the manufacturing renewal service specifically states that renewal is annual.

— Budget separately for government fees, inspections, engineering, GMP/GSDP, commercial costs and costs charged by other local authorities.

— Fees, processing times and licence validity should be confirmed against the service page, decision and specific jurisdictional requirements in force on the date of submission.

A general pharmacy must continuously have a responsible, licensed, full-time pharmacist; the absence of such personnel may trigger a risk of temporary closure. MOHAP’s pharmacy licence renewal service page lists a valid pharmacist licence, commercial licence, Civil Defence fire-safety certificate, and Tatmeen and Riayati registrations. It also requires the facility to be open and active and the responsible pharmacist to be present. The fees and document requirements on that page apply only to the service it covers; confirm requirements separately for other jurisdictions.

Warehouses/stores must maintain a valid EDE GSDP certificate, responsible personnel, an approved scope of activities and specific records of product receipt, dispatch, destination and controlled substances. Factories must continuously comply with EDE quality-management and GMP requirements. Before manufacturing renewal, corrective actions arising from inspection findings should be completed, and industrial licences, key personnel licences, GMP, environmental and Civil Defence documents must be maintained.

— Retail: The responsible pharmacist is present, the facility is active, and licences and safety documents are valid.

— Manufacturing: GMP, key personnel, environmental/Civil Defence/industrial documents, inspection CAPA and annual renewal.

Federal law does not support the claim that a licence automatically transfers with a company’s shares or assets. Relocation of a general or compounding pharmacy, alteration of approved plans, or transfer of ownership to a third party requires approval from MOHAP or the relevant local health authority; that authority may also impose additional transfer conditions within its jurisdiction. Transfer of ownership of a pharmaceutical warehouse/store requires EDE approval, and relocation or alteration of plans must not be implemented in advance.

Factories and contract manufacturing organisations must obtain EDE approval before relocating or changing approved plans; transfer of ownership to a third party also requires EDE approval. An unauthorised transfer or relocation of a warehouse or factory, absence of responsible personnel or loss of a Good Practice certificate may lead to suspension, closure or cancellation of the licence. Changes or transfers of ownership relating to product marketing approvals and import/export licences are separate procedures.

— Before signing, identify the companies, facilities, product marketing approvals, import/export licences and controlled-drug permits involved.

— Confirm individually whether changes to directors, shareholders, address, plans, responsible personnel, scope of activities, products and supply chain require approval.

In principle, medical products imported, distributed, possessed, sold, displayed, remarketed, used or manufactured for circulation in the UAE must first obtain EDE marketing approval, subject to statutory exceptions. Marketing approval is a product-level decision; it is generally valid for 5 years under the law and may be renewed. It is distinct from a pharmacy, warehouse or factory facility licence.

Import, export and re-export of medical products, raw materials or pharmaceutical ingredients cannot be carried out solely on the basis of a facility licence; the applicable EDE approval or permit route must be followed. EDE’s import service requires the relevant product to have marketing approval and the application to be made by the local agent named in that approval. It sets requirements for each shipment, including preliminary approval, release, electronic customs approval, port inspection, invoices, batch and transport documents. Controlled, semi-controlled and narcotic drugs, as well as chemical precursors, are subject to separate permits/approvals and tracking requirements.

— Products: EDE marketing approval, product information, quality/batch, labelling and post-marketing obligations.

— Controlled substances: Obtain additional approvals from EDE and the applicable competent authorities; ensure the responsible person signs and retains tracking/inventory records.