The definitions provided in the Federal Decree by Law No. (38) of 2024 Regarding Medical Products, the Pharmacy Profession, and Pharmaceutical Establishments shall apply to this Resolution.

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.

1. The preliminary approval granted to an Establishment subject to licensing by the Emirates Drug Establishment (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.
2. 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. The prescribed fee in this respect shall be collected.
3. 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.
4. 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.
5. The provisions of Paragraphs (3 and 4) of this Article shall not apply to the services listed in Schedule (2) attached to this Resolution.
6. The medical products, raw materials, chemicals, or precursors imported into the State in the following cases shall be exempt from the import fee stipulated in this Resolution, subject to the quantities and conditions determined by the EDE:
    a. Free medical samples;
    b. Samples imported for scientific research and development purposes by the accredited research and educational centers in the State;
    c. Samples provided for tenders;
    d. Samples imported for registration and pharmaceutical analysis;
    e. Medical products brought by passengers for personal use; and
    f. The 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.
 

The Cabinet shall have the authority to make any amendments to the fees set out in this Resolution, by way of addition, removal or modification.

The fees set out in this Resolution shall be collected by means determined by the Ministry of Finance.

The Chairman shall issue the regulations required to implement the provisions of this Resolution.

The Cabinet Resolution No. (77) of 2023 Regarding the Fees for Using the Electronic Platform for Monitoring and Tracking Pharmaceutical Products shall be repealed. Likewise, any other provision related to any fees set out in other resolutions, the collection of which falls within the scope of authority of the EDE under this Resolution, shall be repealed.

This Resolution shall be published in the Official Gazette, and shall enter into force as of its publication date.