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Cabinet-77-2023 · Federal

Cabinet Resolution No. (77) of 2023 — Fees Using the Electronic Platform for Monitoring and Tracking Pharmaceutical Products

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Concerning the Fees for Using the Electronic Platform for Monitoring and Tracking Pharmaceutical Products

The Cabinet:

- Having reviewed the Constitution; and

- Federal Law No. (1) of 1972, Concerning the Competences of Ministries and the Capacities of Ministers, and its amendments thereof; and

- Federal Law No. (4) of 2015, Concerning Private Health Facilities, and its amendments thereof; and

- Federal Law No. (2) of 2019, Concerning the Use of Information and Communication Technology in the Health Field; and

- Federal Law No. (8) of 2019, Concerning Medical Products, the Pharmacy Profession and Pharmaceutical Establishments; and

- Federal Decree-Law No. (26) of 2019, Concerning Public Finance, and its amendments thereof; and

- Cabinet Resolution No. (59) of 2020 Concerning Tracking and Monitoring Medicines; and

- Based upon the proposal submitted by the Minister of Finance and the Cabinet’s approval, Has resolved as follows:

  1. Definitions In application of the provisions herein, the following words and expressions shall have the meanings ascribed thereto, unless the context requires otherwise: State : United Arab Emirates.

    Ministry : Ministry of Health and Prevention.

    Minister : Minister of Health and Prevention.

    Electronic Platform : The Ministry's central electronic system that aims to track and/or monitor medicines established under Cabinet Resolution No. (59) of 2020.

    Pharmacological : Any product that contains an active substance or group of

    Products

    Product active substances that achieves the intended purpose of use thereof in or on the human or animal body through a biological effect, and which is manufactured, sold, or offered for use in the following cases:

    - Diagnosis, treatment, cure, relief, or prevention of a disease.

    - Restoring, renewing, modifying, or correcting the physiological functions.

  2. Service Fees

    1. The importer of pharmaceutical products from outside the State is obligated to pay a fee for using the electronic platform for tracking and monitoring medicines at a rate of 0.5% of the value of the medicine units in the port invoice price.

    2. The local manufacturer of pharmaceutical products is obligated to pay a fee for using the electronic platform for tracking and monitoring medicines at a rate of 0.5% of the value of the medicine units in the plant invoice price.

  3. Fee Collection The Ministry shall collect the fines stated in this Resolution in accordance with the collection mechanism after coordination with the Minister of Finance in this regard.

  4. Fee Amendment The Cabinet shall have the competence to make any amendments to the fees mentioned in this Resolution, whether by addition, deletion or amendment.

  5. Final Provisions

    1. The collected fines shall be deposited in the account of the unified State treasury, and they shall be monitored in accordance with the criteria set by the Ministry of Finance for this

    Products

    purpose.

    2. A portion of the revenues resulting from the fee stipulated in the Resolution shall be allocated to cover the financial costs of the company implementing the electronic platform, as an exception to the provisions of Article (62) of Federal Law by Decree No.

    (26) of 2019 Concerning the Public Finance.

    3. The Ministry shall pay the fees of the company implementing the electronic platform at a rate of (20) fils per box of medicine, with a maximum of (47) million AED only per annum.

  6. Executive Resolutions The Minister shall issue the resolutions necessary to implement the provisions of this Resolution in coordination with the Ministry of Finance.

  7. Publication and Entry into Force This Resolution shall be published in the Official Gazette and shall be enforced after (30) thirty days as of the date of its publication.

    Mohammed Bin Rashid Al Maktoum Prime Minister

    Issued by Us: On: 22 Dhul Hijja 1444 A.H Corresponding to: 10 July 2023 AD