قانون الرعاية الصحية / الأدوية في الإماراتقرار مجلس الوزراء بشأن رسوم الخدمات التي تقدمها مؤسسة الإمارات للدواء

Article (3) General Provisions 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;

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 3 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.

Article (8) Publication and Entry into Force This Resolution shall be published in the Official Gazette, and shall enter into force as of its publication date. Mohammed Bin Rashid Al Maktoum Prime Minister Issued by Us: Dated: Shawwal 18, 1446 A.H. Corresponding to: April 16, 2025 A.D.

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 5 Schedule No. (1) Attached to Cabinet Resolution No. (40) of 2025 Regarding the Fees for Services Provided by the Emirates Drug Establishment Service Fee in AED Remark SN Service Description Application Issuance Renewal Pharmaceutical Establishments 1 Initial or final inspection for the establishment of any Pharmaceutical Establishment. ____ 1,000 ____ Each time 2 Initial or final inspection of Medical Products Factory and Contract Manufacturing Companies. ____ 3,000 ____ Each time 3 Approval of an engineering design for a pharmaceutical factory or a Medical Products Factory, and Contract Manufacturing Companies. ____ 2,000 ____ Once 4 Licensing of Medical Product Factories and Contract Manufacturing Companies. 100 50,000 25,000 Per year

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 6 Service Fee in AED Remark SN Service Description Application Issuance Renewal 5 Inspection to verify that the Medical Products Factory and Contract Manufacturing Companies comply with Good Manufacturing Practices (GMP). 2,000 ____ ____ Per request 6 Issuance of a certificate of compliance with Good Manufacturing Practices (GMP). ____ 2,000 ____ Per production line, and per year. 7 Licensing of a Medical warehouse. 100 7,500 7,500 Per year 8 Licensing of a medical warehouse for the purpose of re-export. 100 10,000 10,000 Per year 9 Request an inspection to ensure that the Pharmaceutical Establishment complies with any of the Good Manufacturing Practices. 1,000 ____ ____ Per standard, once

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 7 Service Fee in AED Remark SN Service Description Application Issuance Renewal 10 Certificate of Pharmaceutical Establishment’s compliance with Good Manufacturing Practices. ____ 2,000 ____ Per certificate 11 Licensing of marketing office. 100 10,000 5,000 Per year 12 Revocation of the license of any Pharmaceutical Establishment during the license validity period. 100 ____ ____ Per application 13 Relocation of any Pharmaceutical Establishment or change of its name. 100 1,000 ____ Per application Registration of Companies and Assessment of Medical Products 14 Registration of a company for trading in precursors and chemical substances. 100 10,000 5,000 Per year 15 Registration of a medical products manufacturing company. 100 10,000 10,000 Per (5) five years

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 8 Service Fee in AED Remark SN Service Description Application Issuance Renewal 16 Assessment of medical products for the purposes of pharmaceutical research and clinical drug trials. ____ 5,000 ____ Once 17 Accreditation certificate for clinical trial or bioequivalence center. ____ 2,000 ____ Once 18 Analysis or re-analysis of a medical product for Pharmaceutical Establishments and their subsidiaries. 3,000 ____ ____ Per time 19 Marketing authorization for a pharmaceutical or biological product. 100 7,000 3,500 Per (5) five years 20 Marketing authorization for a medical device. 100 5,000 2,500 Per (5) five years 21 Marketing authorization for healthcare products. 100 5,000 2,500 Per (5) five years 22 Classification of a medical product. 500 ____ ____ Per application 23 Repricing of a single medical product. 1,000 ____ ____ Per application 24 Issuance of a medical product quality analysis certificate. ____ 500 ____ Each time

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 9 Service Fee in AED Remark SN Service Description Application Issuance Renewal 25 Issuance of a pharmaceutical product certificate for export purposes. ____ 1,000 ____ Per certificate 26 Issuance of a free sale certificate for a medical product for export purposes. ____ 1,000 ____ Per certificate 27 Issuance of a certificate modifying any of the registration data of a medical company or factory holding a marketing right. ____ 2,000 ____ Per certificate 28 Issuance of a certificate modifying any of the marketing authorization data for a medical product. ____ 1,000 ____ Each time 29 Issuance of a single medical product pricing certificate. ____ 500 ____ Per time 30 Issuance of a batch release certificate for certain bioproducts. ____ 500 ____ Per consignment

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 10 Service Fee in AED Remark SN Service Description Application Issuance Renewal 31 Issuance of a composition statement certificate of a medical product issued by the Drug Quality Control Laboratory. ____ 500 ____ Each time 32 Approval of the safe destruction or disposal of medical products. 100 100 ____ Per time Medical Products Import and Export Permit 33 Entry permit for the purpose of participating in a medical exhibition or conference for any medical products. 100 1,000 ____ Per permit 34 Import permit for any medical products, raw materials, or chemical substances and precursors. 100 (1%) of the invoice value. ____ Per import permit, a minimum of AED 200 per invoice. 35 Export permit for any medical products, raw materials, or chemical substances and precursors. 100 500 ____ Per export permit Narcotic Drugs, Controlled Drugs or Semi-controlled Drugs

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 11 Service Fee in AED Remark SN Service Description Application Issuance Renewal 36 Controlled or semi- controlled drug custody register. ____ 300 ____ Per register 37 Narcotic drug custody register. ____ 300 ____ Per register Medical Product Vigilance 38 Evaluation of the pharmacovigilance plan of the Pharmaceutical Establishment and its subsidiaries. ____ 1,000 ____ Per time Price List of Medicines and Pharmaceutical Products and Names of Licensed Pharmaceutical Establishments 39 Issuance of medical products price list. ____ 500 ____ Per time 40 Issuance of a name list of licensed Pharmaceutical Establishments in the State (excluding pharmacies). ____ 300 ____ Per time Approval of Advertisements for a Medical Product of Company or Establishment not Subject to the Medical and Pharmaceutical Licensing Conditions

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 12 Service Fee in AED Remark SN Service Description Application Issuance Renewal 41 Approval of a printed advertisement by a medical product of a company or establishment not subject to medical and pharmaceutical licensing conditions for (1) one month. 100 600 600 Per language and product 42 Approval of a printed advertisement by a medical product of a company or establishment not subject to medical and pharmaceutical licensing conditions for (1) one year. 100 6,000 ____ Per language and product 43 Approval of an audio advertisement by a medical product of a company or establishment not subject to medical and pharmaceutical licensing conditions for (1) one month. 100 800 800 Per language and product

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 13 Service Fee in AED Remark SN Service Description Application Issuance Renewal 44 Approval of an audio advertisement by a medical product of a company or establishment not subject to medical and pharmaceutical licensing conditions for (1) one year. 100 8,000 ____ Per language and product 45 Approval of an audio- visual advertisement by a medical product of a company or establishment not subject to medical and pharmaceutical licensing conditions for (1) one month. 100 900 900 Per language and product 46 Approval of an audio- visual advertisement for a medical product by a company or establishment not subject to medical and pharmaceutical licensing conditions for (1) one year. 100 9,000 ____ Per language and product

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 14 Service Fee in AED Remark SN Service Description Application Issuance Renewal Approval of Advertisement for a Medical Product for Pharmacy, Public Clinic, or Rehabilitation Center 47 Approval of a printed advertisement by a medical product of a pharmacy, public clinic, or rehabilitation center for (1) one month. 100 800 800 Per language and product 48 Approval of a printed advertisement by a medical product of a pharmacy, public clinic, or rehabilitation center for (1) one year. 100 8,000 ____ Per language and product 49 Approval of an audio advertisement by a medical product of a pharmacy, public clinic, or rehabilitation center for (1) one month. 100 900 900 Per language and product 50 Approval of an audio advertisement for a medical product by a pharmacy, public clinic, or rehabilitation center for (1) one year. 100 9,000 ____ Per language and product

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 15 Service Fee in AED Remark SN Service Description Application Issuance Renewal 51 Approval of an audio- visual advertisement for a medical product by a pharmacy, public clinic, or rehabilitation center for (1) one month. 100 1,000 1,000 Per language and product 52 Approval of an audio- visual advertisement for a medical product by a pharmacy, public clinic, or rehabilitation center for (1) one year. 100 10,000 ____ Per language and product Approval of Advertisement for a Medical Product by Medical Warehouse, Marketing Office, Multidisciplinary Health Center, Diagnostic Center, or Specialized Clinic or Unit 53 Approval of a printed advertisement for a medical product by a medical warehouse, marketing office, multidisciplinary health center, diagnostic center, or specialized clinic or unit for (1) one month. 100 1,000 1,000 Per language and product

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 16 Service Fee in AED Remark SN Service Description Application Issuance Renewal 54 Approval of a printed advertisement for a medical product by a medical warehouse, marketing office, multidisciplinary health center, diagnostic center, or specialized clinic or unit for (1) one year. 100 10,000 ____ Per language and product 55 Approval of an audio advertisement for a medical product by a medical warehouse, marketing office, multidisciplinary health center, diagnostic center, or specialized clinic or unit for (1) one month. 100 1,100 1,100 Per language and product

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 17 Service Fee in AED Remark SN Service Description Application Issuance Renewal 56 Approval of an audio advertisement for a medical product by a medical warehouse, marketing office, multidisciplinary health center, diagnostic center, or specialized clinic or unit for (1) one year. 100 11,000 ____ Per language and product 57 Approval of an audio- visual advertisement for a medical product by a medical warehouse, marketing office, multidisciplinary health center, diagnostic center, or specialized clinic or unit for (1) one month. 100 1,100 1,100 Per language and product

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 18 Service Fee in AED Remark SN Service Description Application Issuance Renewal 58 Approval of an audio- visual advertisement for a medical product by a medical warehouse, marketing office, multidisciplinary health center, diagnostic center, or specialized clinic or unit for (1) one year. 100 11,000 ____ Per language and product Approval of Advertisement for a Medical Product by Pharmaceutical Factory or Company, Medical Supplies Company, Hospital or Convalescent Home 59 Approval of a printed advertisement for a medical product by a pharmaceutical factory or company, medical supplies company, hospital or convalescent home for (1) one month. 100 1,100 1,100 Per language and product 60 Approval of a printed advertisement for a medical product by a pharmaceutical factory or company, medical supplies company, hospital or convalescent home for (1) one year. 100 12,000 ____ Per language and product

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 19 Service Fee in AED Remark SN Service Description Application Issuance Renewal 61 Approval of an audio advertisement for a medical product by a pharmaceutical factory or company, medical supplies company, hospital or convalescent home for (1) one month. 100 1,200 1,200 Per language and product 62 Approval of an audio advertisement for a medical product by a pharmaceutical factory or company, medical supplies company, hospital or convalescent home for (1) one year. 100 12,000 ____ Per language and product 63 Approval of an audio- visual advertisement for a medical product by a pharmaceutical factory or company, medical supplies company, hospital or convalescent home for (1) one month. 100 1,200 1,200 Per language and product

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 20 Service Fee in AED Remark SN Service Description Application Issuance Renewal 64 Approval of an audio- visual advertisement for a medical product by a pharmaceutical factory or company, medical supplies company, hospital or convalescent home for (1) one year. 100 12,000 ____ Per language and product Approval of Advertisement for a Medical Product in Medical or Commercial Directory 65 Approval of a printed or electronic advertisement for a medical product by any pharmaceutical or healthcare establishment in a medical or commercial directory for (1) one year. 100 1,000 ____ Per language and product Approval of Advertisement for a Medical Product through Health Related Audio or Audio-Visual Media Programs

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 21 Service Fee in AED Remark SN Service Description Application Issuance Renewal 66 Approval of an advertisement for a medical product by a pharmaceutical or healthcare establishment through health-related audio media programs for (1) one month. 100 1,200 1,200 Per month 67 Approval of an advertisement for a medical product by a pharmaceutical or healthcare establishment through health-related audio media programs for (1) one year. 100 12,000 ____ Per year 68 Approval of an advertisement of a medical product by a pharmaceutical or healthcare establishment through health-related audio- visual media programs for (1) one month. 100 1,200 1,200 Per month

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Cabinet Resolution of 2025 Regarding the Service Fees Provided by the Emirates Drug Establishment 22 Service Fee in AED Remark SN Service Description Application Issuance Renewal 69 Approval of an advertisement of a medical product by a pharmaceutical or healthcare establishment through health-related audio- visual media programs for (1) one year. 100 12,000 ____ Per year Approval of Participation in Health Related Audio or Audio-Visual Program for Medical Product 70 Approval of participation of a medical product by a pharmaceutical or healthcare establishment in a health-related audio program for (1) one month. 100 800 800 Per month 71 Approval of participation of a medical product by a pharmaceutical or healthcare establishment in a health-related audio program for (1) one year. 100 8,000 ___