- Article (1) Definitions
- Article (2) The Prohibited Activities
- Article (3) Oversight and Enforcement Authorities
- Article (4) Administrative Penalties
- Article (5) Determination of Administrative Violations and Penalties
- Article (6) Collection of Fines
- Article (7) Grievance Against Administrative Penalties
- Article (8) Implementation
- Article (9) Publication and Entry into Force
The Cabinet:
− Having reviewed the Constitution;
− Federal Law No. (1) of 1972, Regarding the Competences of Ministries and the Powers of Ministers, as amended;
− Federal Decree by Law No. (2) of 2011 Regarding the Establishment of the National Emergency, Crisis and Disasters Management Authority (NCEMA), as amended;
− Federal Law No. (14) of 2014 Regarding the Control of Communicable Diseases;
− Federal Law No. (14) of 2016, Regarding the Administrative Violations and Penalties in the Federal Government;
− Federal Law No. (8) of 2019 Regarding Medical Products, Pharmacy Profession, and Pharmaceutical Establishments; and
− Upon the approval of the Cabinet;
Hereby resolves as follows:
Article (1) Definitions
For the purposes of implementing the provisions of this Resolution, the following terms and expressions shall have the meanings assigned to each of them, unless the context requires otherwise:
The State: United Arab Emirates (UAE).
Attorney General: Attorney General of the Federation.
Competent Prosecution: Emergency, Crisis and Disasters Prosecution.
Competent Authorities: Federal and local government entities concerned with health, economy, and emergency, crisis and disasters management, each within the limits of its competence.
COVID-19 Vaccines: Vaccines for the SARS-CoV-2 virus, that aims to provide immunity against COVID-19 and to stimulate the immune system to fight the virus without causing infection and licensed for emergency use.
Article (2) The Prohibited Activities
1. It is prohibited for any natural or legal person to engage in any of the following activities or actions without obtaining the requisite license or approval from the Competent Authorities, or in violation of the applicable rules and procedures:
a. Import, export, re-export, sale, offer for sale, trade, marketing, storage, distribution, transshipment, or transportation of COVID-19 vaccines into the State for transit purposes;
b. Participate in any manner or performed any action that facilitates the conclusion of contracts or transactions related to the activities set out in the preceding Paragraph; and
c. Manufacture or purchase raw materials for the purpose of producing COVID-19 vaccines, as well as production processes including preparation, formulation, derivation, packaging, or repackaging.
2. The Competent Authorities may disclose and publish information regarding the entities, companies, or others licensed to deal with COVID-19 vaccines in any of the manners referred to in the preceding Paragraph.
Article (3) Oversight and Enforcement Authorities
1. The Competent Authorities within the State, within their respective areas of competence, shall monitor compliance with the provisions of this Resolution. Their personnel, holding the status of judicial enforcement officers shall, within their respective competence, be authorized to detect violations and prepare reports documenting any incidents that contravene the provisions of this Resolution. Such reports shall include the violator’s details, nature of the violation, date of occurrence, shall be accompanied by all relevant supporting documents, and shall be submitted to the Competent Prosecution.
2. The Competent Authorities may also take any temporary or precautionary measures as they deem necessary or appropriate to ensure the implementation of this Resolution, particularly:
a. Inspect and destroy seized items if proven to be unfit.
b. Imposing administrative seizure on the seized items subject to the administrative violation, provided that the duration of seizure shall not exceed six (6) months and may be renewed only once. The violator shall bear the costs of storage.
c. Requiring the violator to remove the seized items from the State at their own expense.
3. In all cases, the Competent Prosecution shall be notified of the measures taken.
Article (4) Administrative Penalties
1. An administrative fine of not less than one hundred thousand dirhams (AED 100,000) and not exceeding one million dirhams (AED 1,000,000) shall be imposed on whoever commits a violation of the provisions of Article (2) of this Resolution. In case of recidivism, the administrative fine shall be doubled, provided that its value shall not exceed two million dirhams (AED 2,000,000).
2. In all cases, the following measures may be taken:
1) The violator may be required to rectify the causes of the violation and to remedy the resulting damage. If the violator fails to comply, the Competent Authority shall take the necessary remedial actions and hold the violator liable for the cost of such measures, in addition to twenty-five percent (25%) of the total costs as administrative and supervisory fees. The cost estimate issued by the Competent Authority shall be deemed final.
2) The violating establishment may be closed for a period not exceeding six (6) months, subject to extension.
3. Without prejudice to the powers conferred upon the Oversight and Enforcement Authorities under Article (3) of this Resolution, the Attorney General, or whomever they delegate, shall have the competence to conduct investigation and impose the administrative penalties prescribed for the violations set forth in Article (2) hereof. The Attorney General may issue an order to seize the items in question until the investigation is completed, or the criminal action is adjudicated. The Attorney General may also order the sale of such items by public auction if necessitated by the investigation. The proceeds of such a sale shall cover the payment of fines and expenses.
Article (5) Determination of Administrative Violations and Penalties
1. The Attorney General shall issue a decision specifying the violations falling within the purview of this Resolution, together with the corresponding administrative fines and penalties applicable thereto. Such fines and penalties shall not exceed the limits prescribed under Article (4) hereof. The decision shall further prescribe the period of closure to be imposed upon any violating establishment, as well as the actions necessary for rectifying the cause of the violation.
2. The imposition of the administrative penalties prescribed under this Resolution shall not prejudice any criminal or civil liability, or any other administrative penalties stipulated under the legislation in force in the State.
Article (6) Collection of Fines
The Federal Public Prosecution shall be responsible for collecting the fines imposed on violators. It may coordinate with the relevant government entities and seek their assistance in collecting such fines in cases where the violator fails to pay.
Article (7) Grievance Against Administrative Penalties
A violator may submit a grievance against the administrative penalty imposed upon them within fifteen (15) days from the date of notification of the violation. The grievance shall be submitted with justification to the Attorney General. The Competent Prosecution shall review such grievance and issue a justified decision thereon involving any of the following actions:
1. Dismissal of the grievance;
2. Reduction of the challenged administrative penalty; or
3. Revocation of the challenged administrative penalty.
Article (8) Implementation
All federal and local entities shall, within their respective competence, implement the provisions of this Resolution.
Article (9) Publication and Entry into Force
This Resolution shall be published in the Official Gazette and shall enter into force on the day following the date of its publication.
Translated in cooperation with