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Article 1
Article (1) Definitions For the purpose of applying the provisions of this Resolution, the following words and expressions shall have the meanings assigned thereto respectively, unless the context requires otherwise: State : The United Arab Emirates. Ministry : The Ministry of Health and Prevention.
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Cabinet Resolution of 2020 Regarding Tracking and Monitoring of Drugs 2 Minister : The Minister of Health and Prevention. Health Authorities : Any federal or local government authority in charge of health affairs in the State. Electronic Platform : A central electronic system in the Ministry aiming at tracking and/or monitoring drugs from the plant until the product reaches the consumer and/or patient, through the interconnection between health authorities, pharmaceutical facilities and health facilities. Medical Product : Any medicinal product, medical equipment or product designated for healthcare. Medicinal Product : Any product that contains an active substance or combination of active substances that achieve the intended purpose of its use in or on human beings or animals through a biological effect. Such product is manufactured, sold or offered for use in the following cases: 1. Diagnosis, treatment, curing, alleviation or prevention of diseases; and 2. Restoration, regeneration, modification or correction of physiological functions. Medical Device : A medical product that any material, apparatus, instrument, machine, implant, reagent or system, including its accessories and software, that achieves the intended purpose of its use in or on human beings or animals without having a pharmaceutical or immunological effect or metabolism. Such product is manufactured, sold or offered for use in the following cases: 1. Diagnosis, treatment, curing, alleviation, monitoring or prevention of a disease, injury or disability. 2. Investigation, compensation or modification of an anatomical position. 3. Control of conception. Pharmaceutical Product : A medical product manufactured in a particular pharmaceutical form and designated for specific uses in human beings or animals.
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Cabinet Resolution of 2020 Regarding Tracking and Monitoring of Drugs 3 Narcotic and Psychotropic Substances : Medical and medicinal products and other products that contain any active substance, pursuant to Federal Law No. (14) of 1995 on the Control of Narcotic and Psychotropic Substances, as amended. Dangerous Medical Products : The products which are identified and whose prohibited uses are determined by a resolution to be issued by the Minister. Defective Product : Any medical product that neither meets the quality requirements nor the requirements set out in Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Facilities, or the implementing regulations or resolutions. Adulterated Product : A medical product that has been prepared with a deliberate intent of fraud or disinformation, including: 1. Labelling false or incorrect information on its cover, package, label or package insert, concerning its identity or source in an unreal way. 2. Imitating another medical product using the same art forms and colors of the original product package and label. 3. Adding or removing one or more active or inactive components from its formulation labelled on its cover, package, label or package insert without the approval of the competent department of the Ministry. 4. Changing the amount and volume of one or more of its active and inactive components without the approval of the competent department of the Ministry. Pharmaceutical Facility : A facility licensed to operate in any area of the profession of pharmacy in the State, including any pharmacy, chain of pharmacies, medical warehouse, pharmaceutical lab, pharmaceutical research center, pharmaceutical plant and other facilities defined by the Executive Regulations of Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Facilities.
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Cabinet Resolution of 2020 Regarding Tracking and Monitoring of Drugs 4 Pharmacy : A facility licensed to store, prepare, formulate, dispense, offer or sell medical products directly to the public, through a fixed or mobile, permanent or temporary facility. Chain of Pharmacies : A group of pharmacies owned by a natural or legal person bearing the same name. Medical Warehouse : A place licensed to store a medical product, pursuant to the provisions of Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Facilities, and the Executive Regulations thereof. A warehouse may be licensed for the purpose of importation and distribution or only for the purpose of distribution. Plant : A facility intended for manufacturing Medical Products in whole or in part. Compounding Pharmacy : A pharmacy licensed to prepare Medical Products, based on medical prescriptions, or to meet the health facilities’ needs for the necessary formulations. Health Facility : Any place intended and licensed for conducting medical examination on patients, providing advice to them, assisting in diagnosing their diseases, treating or nursing them, accommodating them for treatment or carrying out any function related to prevention, treatment or rehabilitation, whether such place is owned or managed by a natural or legal person. This definition also includes health facilities of the medical schools operating in the State if they provide any of the abovementioned health services or clinical examinations to patients.
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Cabinet Resolution of 2020 Regarding Tracking and Monitoring of Drugs 5