Import of Medical Products in the UAE: A Legal Overview to the Medical Products Law No. (38) of 2024
Transport & Insurance Focus
The importation of medical products into the United Arab Emirates (UAE) is governed by the Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (the “Medical Products Law of 2024”).
Law Update: Issue 376 – Transport & Insurance
Sakher AlaqailehSenior Counsel, Transport & Insurance
Bassam Al-AzzehSenior Associate, Transport & Insurance
The importation of medical products into the United Arab Emirates (UAE) is governed by the Federal Decree-Law No. (38) of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments (the “Medical Products Law of 2024”). This law outlines the framework for governing medical products, the pharmacy profession, and pharmaceutical establishments, among other provisions. This legislation establishes the key legal framework of medical products imported into the UAE market. This article provides an overview of the main import requirements under the Medical Products Law of 2024.
The Medical Products Law of 2024 builds upon Federal Law No. (8) of 2019, which introduced the basic requirements for the import and export of medical products, including raw materials, as well as regulations on marketing approval, pharmacist licensing, and pharmaceutical facility operations.
Effective from January 2, 2025, the enforcement of the Medical Products Law of 2024 awaits the issuance of its executive regulation.
Before any medical product can be imported, it must receive marketing approval from the EDE.
These regulations will specifically outline the terms and conditions for the supply of pharmaceutical products and medical supplies essential to meeting the community’s needs.
The Medical Products Law of 2024 expanded the regulatory scope, which effected the importation of a number of products such as:
Medical Products: Includes pharmaceutical products, medical devices, healthcare products, biological products, dietary supplements, and cosmetics.
Pharmaceutical Products: products containing active substances used for diagnosis, treatment, cure, mitigation, or prevention of diseases.
The Medical Products Law of 2024 confirms that the Emirates Drug Establishment (EDE), established on September 29, 2023, is the sole central authority responsible for overseeing approvals, including marketing authorizations and import permits related to medical products, pharmacovigilance, medical devices, blood derivative products, genetically modified organisms, stem cells, medicated cosmetics, veterinary medications, and agricultural products.
Before any medical product can be imported, it must receive marketing approval from the EDE, ensuring compliance with safety, efficacy, and quality standards. However, exceptions to this requirement require a decision from the Council of Ministers (Cabinet).
An import permit is mandatory for bringing medical products into the UAE. The permit is issued by the EDE and is conditional upon the following requirements:
Marketing Authorization: The medical product must have a valid marketing approval or emergency use approval from the EDE.
Licensed Entity: The importer must be a licensed biobank, pharmaceutical laboratory, non-clinical and clinical research entity, bioequivalence center, medical warehouse, medical products factory, or contracting company for manufacturing medical products.
Compliance with Technical and Operational Conditions: The importer must fulfill all technical and operational conditions specified by the coming executive regulations of the Medical Products Law of 2024, and until its issuance, the old regulations remain valid.
The EDE shall issue a decision to revoke the approval or permit previously granted for the import, export, or re-export of a medical product, raw materials, or pharmaceutical raw materials if the competent authorities in the country of origin withdraw or suspend the marketing approval granted for the medical product in that jurisdiction.
The importation of controlled and semi-controlled substances, including narcotics, opioids, and anti-anxiety medications, requires special approval from the EDE. These substances are subject to strict regulations to prevent misuse and safeguard public health.
Pharmaceutical consulting offices are prohibited from importing, exporting, storing, distributing or selling any medical products. Similarly, pharmaceutical laboratories are prohibited from importing or storing medical products for the purpose of selling, advertising or introducing them.
Ports in the UAE have dedicated teams from the Ministry of Health and Community Protection, along with other local competent health authorities, responsible for monitoring compliance of shipments of medical and pharmaceutical products with the Medical Products Law. Their duties include inspecting shipments, collecting samples, and requesting necessary information and documentation.
Illegal import and export of medical or pharmaceutical product may result in sever punishments including:
Life Imprisonment
Imprisonment
Financial Penalties
Closure of Facilities:
Confiscation and Destruction of Smuggled Products:
Pursuant to article (164) of the Medical Products Law of 2024, any individual who imports chemical precursors with the intent to utilize them in the manufacture or production of narcotic or psychotropic substances shall be subject to life imprisonment.
Pursuant to articles (164-167) of the Medical Products Law of 2024, any person who imports or exports medical products, raw materials, or pharmaceutical raw materials used in their manufacture without obtaining the requisite license shall be liable to imprisonment for a term ranging from six months to five years.
In addition to imprisonment, the offender may be subject to a monetary penalty ranging between 200,000 and 1,000,000 dirhams for engaging in such illegal importation activities or without proper import authorization.
The court may impose a temporary closure of up to three months or a permanent closure of the pharmaceutical facility or biobank, including the revocation of its license.
All materials associated with the import violation shall be confiscated, with the violator bearing the costs of their destruction.
In summary, the Medical Products Law of 2024 enforces strict regulations on the importation of medical products in the UAE to ensure public safety and compliance with international standards. Importers are required to obtain marketing approval and import permits from the Emirates Drug Establishment (EDE), meeting all technical and operational requirements. Unauthorized importation, particularly of controlled substances, is strictly prohibited. Violations of these regulations can result in severe penalties, including imprisonment ranging from six months to life for offenses such as importing raw materials without authorization or dealing in prohibited substances. Financial penalties of up to 1,000,000 AED, facility closures, and confiscation or destruction of smuggled products further underscore the UAE’s stringent stance on regulatory compliance. As stakeholders await the executive regulation of the Medical Products Law of 2024, strict adherence to existing legal frameworks remains essential to avoiding legal consequences.
For further information,please contact Sakher Alaqaileh and Bassam Alazzeh.
Published in April 2025
