أسئلة قانونية إماراتية عامةقرار مجلس الوزراء رقم (83) لسنة 2020 بشأن النظام الإماراتي لمنتجات الحماية الصحية الشخصية

Article (1) Definitions In application of the provisions of this Resolution, the following words and expressions shall have the meanings assigned thereto, unless the context otherwise requires: State : United Arab Emirates. Ministry : Ministry of Industry and Advanced Technology. Competent Body : The Federal or Local Body concerned with the application of the provisions of this Resolution. Standard Specification : A document that specifies the characteristics of the commodity, material, product, service, or whatever subject to measurement, as well as its description, characteristics, quality level, dimensions, standards, or safety and security requirements therein. Standard Specification als…

Article (2) Scope of Application The provisions of this Resolution shall apply to the Products whose Standard Specifications are indicated in the Annex attached to this Resolution, whether they are launched in the UAE markets, including free zones or for export outside UAE.

Article (3) Supplier Liabilities The Supplier, at any stage of the supply chain, shall comply with the following: 1. Carrying out his activity through a company or an individual establishment registered and licensed in accordance with the relevant Legislation; 2. Obtaining a Conformity Certificate for the Product before its launch in the market, in accordance with ECAS; 3. Ensuring that the product meets the technical requirements contained in the Approved Standard Specifications, indicated in the Annex attached to this Resolution; 4. Cooperating with the Ministry employees and the Competent Bodies and providing the required documents, including technical documents, certificates, data, infor…

Article (4) Technical Requirements The Product prepared for the purpose of launch or trade in the UAE market or for export shall meet the following requirements: 1. The Labels shall meet the requirements of the Standard Specification specified in the Annex attached to this Resolution; 2. The pictures and expressions used on the Product package shall not violate the public order, public morals and Islamic values prevailing in UAE; and 3. All information, pictures and indications used in the labels shall be correct and scientifically

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Cabinet Resolution of 2020 Regarding the UAE System for Personal Health Protection Products 5 and clinically proven.

Article (5) Conformity Verification 1. The Supplier in UAE shall not launch the Product in the local markets or carry out promotional campaigns for the Product unless the Product is registered in accordance with ECAS. 2. The Ministry or the Competent Body, as the case may be, before granting the Product a Conformity Certificate, shall verify its conformity with the Approved Standard Specifications specified in this Resolution, including the verification of the following: a. The Supplier shall meet all procedures required to obtain the Conformity Certificate according to ECAS before launching the Product inside UAE or exporting it; b. The Product shall meet all the requirements of this Resolu…

Article (6) Requirements of the Conformity Assessment Body The Conformity Assessment Body that assesses the Product Conformity shall meet the conditions and requirements specified by the Cabinet Resolution Concerning the UAE Law for the Control of Conformity Assessment Bodies.

Article (7) Liabilities of the Competent Body The Ministry or the Competent Body, as the case may be, shall implement the provisions of this Resolution, and for this purpose it may assume the following: 1. Verifying that the Product meets the requirements of conformity to the Standard Specifications indicated in the Annex attached to this Resolution, and that the technical documents required to be attached to the batch subject to examination are completed; 2. Taking all administrative procedures necessary to pull back or recall the Product that do not comply with this Resolution requirements;

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Cabinet Resolution of 2020 Regarding the UAE System for Personal Health Protection P…

Article (8) Market Survey and Control 1. When the Product is launched in the market, it shall be subject to the control. Therefore, the Ministry or the Competent Body, as the case may be, shall take the necessary measures to control the Product to ensure that it conforms to the Conformity Certificate in all stages of the supply chain. For such purpose, the Ministry or the Competent Body may take any of the following measures: a. Ensuring that all Product launch outlets in UAE are complied with prohibiting importing or launching it in the local markets, except after obtaining the Conformity Certificate; b. Pulling back samples of the Product, from the market or from the Suppliers warehouses,…

Article (9) General Provisions 1. The Approved Standard Specifications indicated in the Annex attached to this Resolution shall be deemed mandatory for application in UAE. This Annex also shall be deemed an integral part thereof. 2. The Ministry shall be responsible for receiving and studying requests concerning registering the Product and granting it the Conformity Certificate in accordance with the provisions of this Resolution. Also, the Ministry may delegate any of the Competent Bodies or appoint an acceptable Conformity Assessment Body to assess the Product conformity, in accordance with the Cabinet Resolution concerning the UAE Law for the Control of Conformity Assessment Bodies. 3. Th…

Article (10) Violations and Sanctions 1. Without prejudice to any penalty or procedure stipulated in any Legislation in force in UAE, should any of the provisions of Articles (3), (4), (5) and (8) of this Resolution is violated, the Ministry or the Competent Body, as the case may be, may impose one or more of the following administrative sanctions:

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Cabinet Resolution of 2020 Regarding the UAE System for Personal Health Protection Products 8 a. Coordinating with the Licensing Authority to cancel the commercial license of the Violating Supplier; and b. Charging the Violator with the expenses and costs of removing and addressing the damages resulting from the violation in the ev…

Article (11) Grievance Procedures 1. Grievances may be filed against Resolutions issued pursuant to the provisions of Article (10) of this Resolution, provided that: a. The grievance is submitted to the Minister or the Competent Body Head or whoever they delegate in accordance with the procedures specified by the Ministry or the Competent Body, as the case may be, within a period not exceeding (14) working days as of the date on which the Violator is notified of the Resolution he wishes to submit a grievance thereon; and b. The necessary documents explaining the grievance reason are attached. 2. The Minister or the Competent Body Head or whoever they delegate shall issue the Resolution he de…

Article (12) Repeals Any provision that violates or contradicts the provisions of this Resolution shall be repealed.

Article (13) Transitional Provisions The Supplier who launch a Product in the market before this Resolution is published and shall be

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Cabinet Resolution of 2020 Regarding the UAE System for Personal Health Protection Products 9 granted a period not exceeding one calendar year as of the date of publishing this Resolution in the Official Gazette to regularize such Product in accordance with the provisions of this Resolution.

Article (14) Publication and Enforcement of Resolution This Resolution shall be published in the Official Gazette and shall be enforced as of the day following the date of its publication. Mohamed bin Rashid Al Maktoum Prime Minister On: 02 Jumada al-Awwal 1442 A.H. Corresponding to: December 17, 2020, A.D

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Cabinet Resolution of 2020 Regarding the UAE System for Personal Health Protection Products 10 Annex Attached to Cabinet Resolution No. (83) of 2020 Regarding the UAE System for Personal Health Protection Products No. Product Technical Requirements Approved Standard Specification 1 أقنعة الوجه الطبية Medical Face Masks – Bacterial filtration efficiency (BFE) – Breathability…