Legislation Details
- Full Title: Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment
- Law Type: Cabinet Resolution
- Law Number: No. (40) of 2025
- Issued Date: 16 Apr 2025
- Effective Date: 29 Apr 2025
- Official Gazette: No. 798
- Sector: Finance and Banking
- Status: Active
- Number of Articles: 16
- Chapters/Parts: 0
- Amendments: 0
Summary
This Cabinet Resolution regulates the service fees charged by the Emirates Drug Establishment (EDE), the government body responsible for overseeing the pharmaceutical sector in the UAE. The resolution sets out the specific fees for various services provided by the EDE, such as licensing, import permits, and other administrative procedures. It aims to standardize and streamline the fee structure for businesses and individuals operating in the pharmaceutical industry. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025) The resolution is important for pharmaceutical companies, importers, and healthcare providers in the UAE, as it outlines the mandatory fees they must pay to the EDE for various regulatory and administrative services. Compliance with the fee structure is crucial for businesses to operate legally and avoid penalties. The resolution also provides exemptions and exceptions for certain types of imports, such as free medical samples and research materials, which can help reduce the financial burden on the industry. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025)
What is the scope and purpose of this law?
The scope of this Cabinet Resolution is to regulate the service fees charged by the Emirates Drug Establishment (EDE) for various services it provides to the pharmaceutical sector in the UAE. The purpose is to standardize and streamline the fee structure, ensuring transparency and consistency in the fees paid by businesses and individuals operating in the pharmaceutical industry. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Art. 2)
What are the key definitions under this law?
The definitions provided in the Federal Decree-Law No. (38) of 2024 Regarding Medical Products, the Pharmacy Profession, and Pharmaceutical Establishments shall apply to this Resolution. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Art. 1)
What are the main obligations and requirements?
The main obligations and requirements under this Resolution include:
- Fees shall be collected for the services provided by the Emirates Drug Establishment as detailed in Schedules (1) and (2) attached to this Resolution, at the rates specified alongside each service. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Art. 2)
- The preliminary approval granted to an Establishment subject to licensing by the EDE shall not be deemed a license, and the Establishment may only engage in its activity after it obtains a final license from the EDE. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Art. 3(1))
- The assignment of a valid license issued by the EDE in favor of any pharmaceutical establishment shall be deemed revocation of such a license, which requires the assignee natural or legal person to apply for a new license, regardless of the remaining validity period of the assigned license. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Art. 3(2))
What licensing, registration, or approval requirements exist?
The Resolution does not specify any new licensing, registration, or approval requirements. However, it states that the preliminary approval granted to an Establishment subject to licensing by the EDE shall not be deemed a license, and the Establishment may only engage in its activity after it obtains a final license from the EDE. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Art. 3(1))
What rights and protections does this law provide?
The Resolution does not explicitly provide any specific rights or protections. It focuses on regulating the service fees charged by the EDE and does not address individual or business rights. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025)
Which authorities or bodies are responsible for enforcement?
The Resolution states that the Chairman of the Emirates Drug Establishment shall issue the regulations required to implement the provisions of this Resolution. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Art. 6)
What are the penalties for non-compliance?
The Resolution does not specify any penalties for non-compliance. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025)
What fees, charges, or financial provisions are specified?
The Resolution outlines the following key financial provisions:
- Fees shall be collected for the services provided by the Emirates Drug Establishment as detailed in Schedules (1) and (2) attached to this Resolution, at the rates specified alongside each service. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Art. 2)
- A fee of 1% of the total invoice value shall be collected for every import permit in respect of any medical products, raw materials, chemicals and precursors that are not subject to the prescribed tariff. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Art. 3(3))
- Either 1% of the value of the invoice calculated on a CIF (Cost, Insurance, and Freight) price approved by the EDE, for each import permit for any medical product, raw material, chemical, or precursor that is subject to the prescribed tariff, or 1% of the total invoice value shall be collected; whichever is higher. In all cases, the fee amount shall not be less than AED 200 per invoice. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Art. 3(4))
What exemptions or exceptions apply?
The Resolution provides the following exemptions from the import fee:
- Free medical samples
- Samples imported for scientific research and development purposes by the accredited research and educational centers in the State
- Samples provided for tenders
- Samples imported for registration and pharmaceutical analysis
- Medical products brought by passengers for personal use
- Chemical products, materials, and precursors imported as a replacement for materials for which the import permit fees have been collected but were damaged while being shipped to the State
These exemptions are subject to the quantities and conditions determined by the EDE. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Art. 3(6))
How does this law interact with other UAE legislation?
This Cabinet Resolution is related to the following UAE legislation:
- Federal Decree-Law No. (26) of 2019 Regarding Public Finance, as amended
- Federal Decree-Law No. (28) of 2023 Regarding the Establishment of the Emirates Drug Establishment
- Federal Decree-Law No. (38) of 2024 Regarding Medical Products, the Pharmacy Profession, and Pharmaceutical Establishments
- Cabinet Resolution No. (7) of 2007 Regarding the Health Advertisements Regulations, as amended
- Cabinet Resolution No. (44) of 2016 Regarding the Fees for Certain Services Provided by the Ministry of Health and Prevention, as amended
- Cabinet Resolution No. (30) of 2021 Regarding the Fees for Services Provided by the Ministry of Climate Change and Environment
- Cabinet Resolution No. (77) of 2023 Regarding the Fees for Using the Electronic Platform for Monitoring and Tracking Pharmaceutical Products (which is repealed by this Resolution)
(Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Preamble and Art. 7)
When did this law come into effect?
This Cabinet Resolution shall be published in the Official Gazette and shall enter into force as of its publication date, which is 29 Apr 2025. (Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment, 2025, Art. 8)
Source Documents
This article analyses Cabinet Resolution Regarding the Service Fees Provided by the Emirates Drug Establishment for legal research and educational purposes. For the purpose of interpretation and application, reference must be made to the original Arabic text. In case of conflict, the Arabic text prevails. This does not constitute legal advice.