قانون الرعاية الصحية / الأدوية في الإماراتقرار مجلس الوزراء بشأن اللائحة التنفيذية للقانون الاتحادي في شأن المنتجات الطبية ومهنة الصيدلة والمنشآت الصيدلانية

Article (1) Definitions The definitions mentioned in Federal Law No. (8) of 2019, referred to in the present Resolution, shall apply. Otherwise, the following words and expressions shall have the meanings assigned thereto respectively, unless the context otherwise requires: Health Authority : Any federal or local government entity concerned with health affairs in the State. Product Suspension : Suspension of the circulation or use of the product. Healthcare Profession : A health profession licensed to be practiced in the State, as determined in Cabinet Resolution No. (20) of 2017, referred to above. Narcotic Drug : A medical product that contains any of the active ingredients listed in Sched…

Article (1) The provisions of Articles (2 through 7) of this annex shall apply to those coming to or departing from the State in case of holding any of the controlled substances: 1. N-Narcotic drugs 2. Psychotropic substances

Article (2) Price of Medical Products 1. Discounts from the prices set by the Ministry may not be granted, but special prices may be set in the course of applying the drugs dispensing system by the Health Authority, as the case may be, or through the government health insurance schemes. 2. Special prices may be set in the course of applying the drugs purchase system by the health bodies. In such case, drugs shall be dispensed, depending on the purchase price applicable for the health facility. 3. Without prejudice to the provision of Clause (1) of this Article, pharmacies may be granted a quantity of medical products for free and the granted quantity shall not exceed the percentage of the ov…

Article (2) The controlled substances (N-Narcotic drugs and psychotropic substances) shall include the medical products containing any active ingredients listed in the following schedules: 1. INCB Schedules Nos. (I, II, III or IV) annexed to the 1961 Convention on Narcotic Drugs, amended by the 1972 Protocol, as amended. 2. INCB Schedules Nos. (I, II, III or IV) annexed to the Convention on Psychotropic Substances of 1971, as amended. 3. Schedules Nos. (1, 2, 3, 4, 5,6,7 or 8) attached to Federal Law No. (14) of 1995 referred to hereinabove.

Article (2) of this Annex, the applicable steps shall be observed depending on the classification of the active ingredient.

Article (3) Suspension of the Medical Product The Body Concerned may suspend the medical product's circulation at public and private health facilities falling within their respective areas of competence, and shall report the same to the Ministry within twenty-four hours from the date of issuance of the suspension decision, on the

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments 4 form designated thereby for such purpose. Accordingly, the Ministry shall take the necessary decision in this regard.

Article (3) Those coming from abroad shall comply with the following requirements when bringing the controlled substances: 1. Obtain prior approval of the ministry for bringing substances via its website, and they shall disclose the same the official ports of the State. It is required to submit the following documents in Arabic or English for the purpose of obtaining the permission:

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments 28 a. Medical report to be issued by the health facility, at which the patient is treated, authenticated by the health body of…

Article (4) Controls for Bringing the Medical Product The medical product shall be brought, possessed or held by any person upon entering the State for personal use in accordance with the conditions and rules set out in Annex No. (1) attached to the present Resolution.

Article (4) The terms and controls provided for in this annex shall apply to the diplomatic missions, official government entities, delegations involved in sports activities and others when they are in possession of controlled substances at the time of coming to or departing from the State. In all cases, it is required to coordinate with the ministry in order to complete the necessary actions in this regard.

Article (5) Obligations of Non-Pharmaceutical Establishments Non-pharmaceutical establishments that are determined under a resolution of the Minister and that are permitted to sell, display, store and circulate Over-the-counter (OTC) medical products shall: 1. Purchase the medical product from the warehouse licensed by the Ministry; 2. Adhere to the types of OTC medical products, according to the classification approved by the Ministry; 3. Obtain the approval of the entity licensing the establishment; 4. Comply with the approved storage conditions as for each product; and 5. Adhere to the price set by the Ministry, if any.

Article (5) 1. The patient, who leaves the State and needs to take possession of psychedelic drugs, shall obtain the approval of the ministry based on both a valid medical prescription and a report of the treating physician, within the limits of quantity appropriate to the duration of treatment. 2. If the patient, who leaves the State, is in need to be injected with psychedelic drugs during the duration of travel, he shall be accompanied by a healthcare practitioner. The patient shall be allowed to hold drugs at an appropriate quantity under the approval of the ministry based on a valid medical prescription and report of the treating physician. 3. If the patient, who leaves the State, is in…

Article (6) Requirements for Practicing the Pharmacy Profession No person may engage in any activity in the field of pharmacy profession or work as a pharmacy technician, unless such a person is duly licensed by the Health Authority, in accordance with the

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments 5 conditions and controls set out in Cabinet Resolution No. (20) of 2017, referred to hereinabove, as amended.

Article (6) 1. In case a transit traveler is holding controlled substances, he shall be allowed to hold the quantity sufficient for the period of his stay in the State. The excess quantity shall be seized and retained, and shall be returned to the transit traveler upon leaving the State. 2. In case a traveler coming to the State is holding controlled substances, quantities in excess of the allowed threshold or in excess of the quantity proportional to his treatment period as

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments 30 mentioned in the medical pres…

Article (7) Record of Practitioners 1. Those who are entered in the national record created in the Ministry and the special record created in the Body Concerned shall be pharmacy and pharmacy technician practitioners and shall be licensed to practice the profession in the State. 2. The national and special records shall contain a section for pharmacists and another section for pharmacy technicians. 3. The following data shall be listed in the national and special records: a. Personal data of the practitioner; b. Data of the license granted to the practitioner; c. Current status of the practitioner, i.e. licensed and on the job, his license is expired, etc.); and d. Any other data determined…

Article (7) The following controlled drugs may not be brought by anybody coming to the State: 1. Drugs that do not display details of the active ingredient in Arabic or English. 2. Expired drugs for personal use. 3. Drugs that are of unknown components or having no label showing their components. 4. Drugs whose circulation in the State is prohibited according to the lists specified under a resolution of the Minister or his designee, and those described as prohibited on the Ministry’s website.

Article (8) License and Renewal of the License to Practice the Profession The Health Authority shall, as the case may be, consider and decide on the applications submitted for licensing or renewing the licenses of persons to practice pharmacy profession and pharmacy technician profession in accordance with the controls and conditions set out in Cabinet Resolution No (20) of 2017, referred to hereinabove, as amended.

Article (8) The provisions of Article (9) et seq. shall apply to the persons coming to or departing from the State in case they bring any of the following drugs or medical supplies for human use: 1. Semi-controlled drugs; 2. Non-controlled drugs that are dispensed under a prescription-only medicines (POM) for human use (not including controlled drugs);

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments 31 N3. on-controlled drugs that are not dispensed under a prescription-only medicines (POM) for human use; 4. Preventive medicine’s drugs; 5. Biological drug…

Article (9) Requirements for Licensing Visiting Pharmacists The following requirements and controls shall be met to issue a temporary license for a visiting pharmacist to practice the profession: First: The requirements and controls for visiting pharmacists inside the State: 1. He shall be licensed to practice the pharmacy profession in his original employer in the State under a valid license.

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments 7 2. He shall submit a copy of the certificate of good conduct issued by the Health Authority, proving his good cond…

Article (9) Semi-controlled drugs, non-controlled drugs and medical supplies brought by the traveler coming to the State shall be subject to the following provisions: 1. For POMs: The traveler coming to the State may bring, for his / her personal use, non-controlled drugs that are dispensed only based on a POM for personal use, within the limit of a quantity that is proportional to the period of his / her stay in the State, provided that the quantity of such drugs may not exceed the traveler’s personal use for a maximum period of six (6) months. In addition the traveler shall have in place a medical report or copy of a prescription indicating the patient’s data. 2. For Over-the-counter (OTC)…

Article (10) Adherence to the Scope of Work and Area of Activity The pharmacist who is licensed to practice the pharmacy profession shall abide by the scope of work and area of activity as defined in the license granted to him to practice the profession in the State. He shall also perform his job duties accurately and honestly as required by his profession, according to the acknowledged scientific and technical principles, and the responsibilities and principles contained in the Approved Code of Ethics and Professional Conduct for Health Professionals.

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy…

Article (10) The terms and controls provided for in this annex shall apply to the diplomatic missions, official government entities, delegations involved in sports activities and others when they are in possession of drugs or medical supplies at the time of coming to or departing from the State. In all cases, it is required to coordinate with the ministry in order to complete the necessary actions in this regard.

Article (11) Providing First Aid A pharmacist may provide first aid, provided that he holds a training certificate regarding such aid issued by an accredited body in this field.

Article (11) Possession of preventive medicine’s drugs shall be subject to the following provisions: 1. Travelers coming to the State shall provide a medical report or document indicating the type of disease and treatment required or a copy of a medical prescription indicating the patient’s details. 2. Travelers coming to the State may be in possession of preventive medicine’s drugs within the limit of the quantity required for their personal use, in proportion to the length of their stay in the State but not exceeding the quantity required for their personal use for not more than six (6) months. In addition, the excess quantity shall be delivered to the preventive medicine center located at…

Article (12) Requirements for Dispensing Medical Prescriptions In addition to the requirements set forth in Article (49) of the Law, a medical prescription shall: 1. Be written in a non-erasable, unchangeable material if the prescription is written. 2. Contain electronic signature and electronic code if the prescription is electronically printed out. 3. Contain the administration method of the drug or preparation dispensed therein. 4. It has not been issued for more than sixty days, unless it contains controlled substances or products. 5. Contain the patient’s gender. 6. Contain the treatment duration and determine the repetition times, if necessary, even if it exceeds the duration mentioned…

Article (12) The traveler departing from the State may be in possession of semi-controlled or non-controlled drugs or medical supplies for personal use, by virtue of a permission or license from the Ministry whenever requested.

Article (13) Validity Period of Prescriptions of Controlled Substances and Products Controlled substances and products may not be dispensed if more than three years that may be extended by a further period have passed since the issuance of the medical prescription, subject to the approval of the Health Authority, as the case may be.

Article (13) The drugs governed by the provisions of this Resolution and referred to in this Annex shall satisfy the following requirements: 1. They shall be placed in their original packages that are tightly closed, or in packages having a label issued by health or pharmaceutical establishment indicating the drug composition, the patient’ name and the storage temperature that ensures the patient safety. 2. Controlled drugs shall be included in the Ministry’s lists posted on the Ministry’s website or are permitted by the Ministry to be imported. 3. The technical requirements on transporting the drugs that require cooling shall be observed. 4. The drug quantities exceeding the quantity permit…

Article (14) Conditions for Replacement of Medical Products 1. A pharmacist may replace a pharmaceutical product with an equivalent pharmaceutical product after giving advice and counseling to the patient in this regard so as to provide an opportunity to the patient to choose the pharmaceutical product he prefers. The pharmacist shall explain to the patient that the equivalent pharmaceutical product contains the same formula of the pharmaceutical product prescribed or previously dispensed. 2. The pharmacist shall, upon replacing a pharmaceutical product with an equivalent pharmaceutical product, take into account the following: a. The patient’s consent of the replacement of the product with…

Article (14) First: The following drugs shall be prohibited from being brought into the State with the coming persons: 1. Drugs without the leaflet of the active ingredient in Arabic or English; 2. Radioactive drugs; 3. Expired drugs for personal use; 4. Drugs of unknown ingredients or without a leaflet indicating the ingredients; 5. Drugs of alternative medicine and medical herbs that contain unknown ingredients; 6. Drugs whose circulation is prohibited within the State in accordance with the lists specified by a resolution of the Minister or his designee, provided that they are listed on the Ministry’s website. Second: The Ministry’s inspectors shall provide technical support to the employ…

Article (15) Controls for the Custody of Controlled and Semi-Controlled Substances and Products 1. The pharmacist in charge of the custody of controlled and semi-controlled substances and products shall enter the dispensed medical prescriptions of such substances in the records determined by the Minister, in accordance with the following controls and requirements: a. All controlled and semi-controlled substances and products shall be entered in a special record for all of such products, provided that the dispensing of each item is recorded in separate pages, taking into account that a sufficient number of pages is dedicated to each item as for paper records and the product is not recorded in…

Article (16) Term of the License of the Pharmaceutical Establishment The license for starting up a pharmaceutical establishment shall be valid for at least one year, renewal for a similar term, upon a request to be submitted for such purpose.

Article (17) Assignment of Ownership of the Pharmaceutical Establishment Subject to the approval of the Health Authority, as the case may be, ownership of the pharmaceutical establishment may be assigned to third parties, in accordance with the following conditions: 1. Verifying the conditions related to the transfer of ownership; 2. Submitting the duly certified assignment documents; and 3. Submitting proof of settlement of any financial claims on the pharmaceutical establishment to the licensing authority or the insurers.

Article (18) Serious Violations which Require the Closure of the Pharmacy The following violations shall be deemed serious violations. The Health Authority may, as the case may be, issue a decision on the temporary closure of the pharmacy for a period not exceeding one month in case of performing any of the following actions: 1. Failure to comply with the recall and suspension decisions of some medical products issued by the Health Authority, as the case may be;

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments 12 2. Circulation of medical products purchas…

Article (19) Serious Violations which Require the Revocation of the Pharmacy’s License The following violations shall be deemed serious violations. The Health Authority may, as the case may be, issue a decision on the revocation of the pharmacy’s license in case of performing any of the following actions: 1. Manipulation in the records of controlled or semi-controlled drugs and circulation of the same in a manner contrary to the legislation in force in the State; 2. Repetition of manipulation of the expiry date of the medical products with the precedent of temporary closure if the establishment because of that; 3. Continuation of the practice of the activity after the expiry of the time limi…

Article (20) Absenteeism of the Pharmacist in-charge In case of absenteeism of the pharmacist who is in charge of the management of the pharmacy, the pharmacy owner shall assign its management and supervision over it to another pharmacist licensed to practice the pharmacy profession to act as another pharmacist existing in the same pharmacy or another licensed pharmacy within the same emirate. The owner may also assign the same to a visiting pharmacist, provided that a pharmacy technician exists in the pharmacy. In all cases, the period of absenteeism shall not exceed three months, whether consecutive or non- consecutive, over the year.

Article (21) Pharmacy Chain A license may be issued for starting up more than one Pharmacy in accordance with the pharmacy chain system, provided that the following requirements are satisfied: 1. The number of pharmacies within the chain shall be within the limits permitted by the Health Authority, as the case may be. 2. The pharmacies within the chain shall be owned by one natural or legal person. 3. All pharmacies within the chain shall obtain a separate license for the establishment and shall satisfy the health and technical requirements and the required controls. 4. In case of adding one or more pharmacy owned by another person(s) to the pharmacy chain, the necessary actions shall be tak…

Article (22) Area of Activity of the Pharmacy 1. Without prejudice to the provision of Article (10) of this Resolution, a pharmacy may not be used as a medical clinic or for any other purpose and its work shall be restricted to the following activities: a. Storage, display, dispensing and sale of medical products, including food and milk for infants and young children; and b. Composition or preparation of medical products in accordance with the legislation in force in this regard. 2. In addition to the activities set forth in Clause (1) of this Article, the pharmacy may perform the following sub-activities: a. Storage, display, dispensing and sale of medical supplies for personal use; b. Mea…

Article (23) Conditions for Licensing Certain Pharmacies The Health Authority may, as the case may be, may issue a license for starting up private pharmacies affiliated to a governmental non-healthcare body, a public establishment or

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments 15 associations or organizations of public welfare, or the private hospitals and medical centers, provided that the following requirements are satisfied: 1. A license application shall be submitted to the Health Authority, as the case may be. 2. The pharmacy shall be managed by…

Article (24) Technical and Health Requirements for Medical Warehouses The medical warehouse shall satisfy the technical and health requirements set out in Annex No. (2) attached to the present Resolution.

Article (25) Serious Violations Which Require Closure of Medical Warehouse The following violations shall be deemed serious violations. The Licensing Authority may, within its scope of competence, issue a resolution either to close the Medical Warehouse on precautionary grounds or to suspend its license temporarily in case of performing any of the following actions: 1. Practice of the activity before obtaining the license; 2. Circulation of counterfeit, falsified or defective products;

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments 16 3. Failure to comp…

Article (26) Serious Violations Which Require Revocation of the License of the Medical Warehouse The following violations shall be deemed serious violations. The Licensing Authority may, within its scope of competence, issue a resolution to revoke the license of the Medical Warehouse in case of performing any of the following actions: 1. Manipulation in the records of controlled and semi-controlled drugs and precursor chemicals; 2. Repetition of manipulation of the expiry date of the medical products with the precedent of previous notice and temporary closure for the same reason;

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerni…

Article (27) Competences of Pharmaceutical Consulting Firms Pharmaceutical consulting firms shall be competent to: 1. Provide strategic guidance to pharmaceutical establishments; 2. Provide good management advice in the pharmaceutical field; 3. Provide professional training and development in the pharmaceutical field; 4. Provide consultations in the development of medical products; 5. Provide consultations in the field of studies, researches and management of pharmaceutical projects; 6. Provide consultations related to pharmacovigilance and the safety of pharmaceutical products; 7. Provide consultations related to the quality of the services of the pharmaceutical establishments and pharmaceu…

Article (28) Conditions for the Person in Charge of Pharmaceutical Laboratory or Research Center The person in charge of the pharmaceutical laboratory or research center shall be qualified, available on a full-time basis for technical supervision and licensed in accordance with the following conditions: 1. He shall hold an academic qualification from one of the universities or centers recognized in the State in any of the following specializations: pharmacy, one of the specializations of chemistry, microbiology or other relevant disciplines. 2. He shall have at least five years of experience in the area of specialization.

Article (29) Serious Violations Which Require Closure of the Factory The following violations shall be deemed serious violations. The Ministry may, on its own and in coordination with the Competent Bodies or based on the recommendation of the Competent Bodies, issue a resolution either to close the factory on precautionary grounds or to suspend its license temporarily in case of performing any of the following actions: 1. Establishment of repetition of the factory’s failure to apply the basis of Good Manufacturing Practice in a manner that affects the quality and safety of the medical product and the public health although a notice is served thereupon; 2. Establishment of non-safety of the p…

Article (30) Possession of Controlled Substances and Products The licensed physician (anesthesiologist or surgeon) may possess controlled substances and products to be used for the purposes of his/her professional duties within the following quantities: First: Health Facilities with no internal pharmacy: 1. For Narcotic Substances: Based on the standard quota approved by the Health Authority in accordance with number of patients receiving treatment and dosages recognized, provided that the quantity shall not exceed the threshold needed to cover the needs of use for a maximum period of two months. 2. The standard stock of narcotic drugs may be replenished more than once within a single month…

Article (31) Import Controls for Certain Products The following requirements shall apply as a prerequisite for completing the customs clearance procedures for any import shipment containing controlled substances and products or raw materials involved in the manufacturing of controlled substances and products: 1. An import license and import permission shall be issued by the Ministry for private facilities. For government entities, however, only an import license issued the ministry shall be sufficient. 2. A document shall be submitted to prove that the substances imported are conforming to the documents of shipment and labels placed thereon. 3. The approval of the Ministry’s inspector at the…

Article (32) Termination of Possession and Custody of Controlled Substances and Products In case the holder of a license for possession of controlled substances and products ceases to operate or where the person in charge of its custody gives up the same for whatever reason, the license holder shall take appropriate actions for conducting an inventory count on such controlled substances and products and initiating the handover procedures of the same as follows: 1. In case the holder of a license for possession of controlled substances and products ceases to operate, the license issuer shall be duly notified. In case such controlled substances and products are narcotic substances, the Ministr…

Article (33) Making Medical Products Available 1. The Ministry shall, in coordination with the relevant Health Authority, create and periodically update a list of products of strategic medical stock, in order to ensure that the necessary medical products are made available to meet the society’s needs on a permanent basis. 2. Pharmaceutical establishments shall make the products included in the strategic medical stock list available, in order to ensure permanent availability of basic or necessary drugs at medical warehouses and pharmacies of public and private hospitals in quantities that are proportional to the patients’ needs. The Health Authority shall monitor the balances of products incl…

Article (34) Donation of Medical Products The donation of medical products shall be subject to the following controls and conditions: 1. Donation shall take place for the benefit of charities, government entities, public institutions or public welfare organizations or directly to persons whose medical condition requires such

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments 24 products and who have a valid medical prescription yet are falling short of the funds needed to acquire them. 2. A relevant permit shall be obtained from the Health Authority. 3. The…

Article (35) Pharmacy Maintenance Conditions and Controls In the course of carrying out maintenance for a pharmacy, the following conditions and controls shall be observed to ensure quality and validity of the medical products: 1. The medical products may not be vulnerable to any factors that might adversely affect their quality and safe use. Failing which, the medical products available at the pharmacy shall be relocated to any other place that satisfies the requirements of ensuring their quality and validity, provided that the Health Authority shall, as the case may be, approve the relocation mechanism and storage location before the relocation actions start. Should the pharmacy contain co…

Article (36) Amendment of Resolution’s Annexes Under a resolution of the Minister and subject to coordination with the remaining health authorities, the provisions of Annex No. (1) and Annex No. (2) attached to this Resolution may be amended.

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments 26

Article (37) Adjustment of Affairs All bodies governed by the provisions of this Resolution shall adjust their respective affairs in conformity with the provisions hereof, not later than six (6) months of its issuance date.

Article (38) Executive Resolutions The Minister shall issue any other resolutions deemed necessary for implementing the provisions of this Resolution.

Article (39) Repeals Any other provision that goes against or conflicts with the provisions of this Resolution shall be repealed.

Article (40) Publication and Entry into Force This resolution shall be published in the Official Gazette and shall enter into force of the day following its publication date. Mohammed bin Rashid Al Maktoum Prime Minister Issued by Us On: 21 Safar, 1443 AH Corresponding to: 28 September, 2021 AD

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Cabinet Resolution of 2021, Concerning the Executive Regulations of Federal Law of 2019 Concerning Medical Products, Pharmacy Profession and Pharmaceutical Establishments 27 Annex No. (1) Attached to Cabinet Resolution No. (90) of 2021 Concerning the Terms and Controls for Bringing, Possession or Holding of a Medical Product by any Person Upon Entering the State for Personal Use