In application of the provisions of this Decree-Law, the following words and phrases shall have the meanings assigned to each of them, unless the context otherwise requires: State: The United Arab Emirates. The Ministry: Ministry of Health & Prevention. The EDE: The Emirates Drug Establishment (EDE) Minister: Minister of Health & Prevention. Board of Directors (BOD): The Emirates Drug Establishment Board of Directors. Chairman: EDE Chairman BOD. Competent Health Entity: Any local government body concerned with health affairs, each within their jurisdiction. Medical Product: The product described in Article (2) herein. Pharmaceutical Product: Any product that contains an active substance or group of active substances that achieves the intended purpose of use thereof in or on the human or animal body through a biological effect, and which is manufactured, sold, or offered for use in the following cases: 1. Diagnosis, treatment, cure, relief, or prevention of a disease. 2. Restoring, renewing, modifying, or correcting the physiological functions. The following shall also be included in Pharmaceutical Products: 1. BioPharmaceutical Products; 2. Food Supplements; 3. Cosmetics. Biopharmaceutical Products: Pharmaceutical Products obtained by biotechnology from a living organism, and are divided into several categories such as vaccines, monoclonal antibodies, growth factors, blood derivatives, plasma derivatives, advanced medical therapy products, and allergy detection products. Advanced Medical Treatment Products: Pharmaceutical Products based on modern and innovative technologies such as gene and cell therapy, stem cell therapy, genetic engineering, and engineered tissues, which are designed to treat, prevent, or diagnose complex and genetic diseases and injuries by modifying genes or replacing abnormal cells and tissues. Local Product: It is a Pharmaceutical Product that has obtained Marketing Approval from the Marketing Rights holder within the State and is manufactured in local factories at manufacturing rates determined by the EDE. Food Supplements: Products taken orally that support the human diet and do not treat, diagnose, or prevent diseases. They consist of natural or partially manufactured products, or both, and do not require a prescription or direct medical supervision when used. Cosmetics: Products with a medical effect that are used on the human body to produce a desired local effect on the skin, hair or nails and do not require a prescription or direct medical supervision for their sale when used. Innovative Product: A Pharmaceutical Product that is the first of its kind in its category, either because it contains new components or formulations that have not been used before to treat a specific condition or is used in new ways, or it was developed and marketed for the first time by the developing company and has not previously obtained Marketing Approvals in the State, and the Marketing Approval for the product was submitted to the EDE by the company that invented it or through someone it authorized for this purpose, while the product enjoyed valid patents at the time of submission. Orphan Pharmaceutical Product: A Medical Product intended to treat, diagnose, or prevent a rare disease or condition. Alternative Product: A Pharmaceutical Product that is similar to another Pharmaceutical Product, having the same qualitative and quantitative composition of active ingredients, the same Pharmaceutical Form, and being bioequivalent thereto. It may have the status of pioneer, so it will be the first generic Pharmaceutical Product to obtain Marketing Approval in the State, similar to the innovative product that has not obtained Marketing Approval in the State in terms of indication, Pharmaceutical Form, active ingredients, and Bioequivalence, without prejudice to the intellectual property laws in force in the State. Compassionate Use: Use of a Medical Product for a patient with a serious illness or life-threatening condition outside of Clinical Trials when no alternative treatment options are available. Medical Equipment: A Medical Product that contains a substance, device, instrument, engine, implant, detector, or system, including accessories, and operating software thereof. It shall include wearable devices and products based on AI technology, which shall achieve the intended purpose of its use in or on the human or animal body without a pharmaceutical, immune, or metabolic effect. In addition, it is manufactured, sold, or offered for use in the following cases: 1. Diagnosis, treatment, cure, relief, or prevention of a disease, an injury, or a disability; 2. Detection, modification, or replacement of anatomical position. 3. Birth Control. Health Care Product: Any Medical Product that is used for the general health care of humans or is not intended for the diagnosis, treatment, cure, or prevention of any disease, and does not require a prescription or direct medical supervision when used. Pharmaceutical Product: A Medical Product manufactured in a specific Pharmaceutical Form and has specific uses in humans or animals. Veterinary Product: A substance, a composition of substances, or a material intended for the treatment, prevention, or diagnosis of medical conditions in animals, or for the repair or modification of physiological functions in animals. Personalized Medicine: A personalized or precision medicine model that considers variation in genes, environment, and lifestyle to determine treatment and prevention of disease and more accurately predict which product treatment and prevention strategies will work best for each individual patient. Defective Product: Any Medical Product that does not meet the quality requirements and does not meet the requirements specified in this Decree-Law, its Executive Regulations, and the decisions issued in implementation thereof. Counterfeit Product: A Medical Product that has been deliberately prepared with the intent to deceive or mislead, including: 1. Providing its packaging, packaging, identification card or internal leaflet with false or incorrect information concerning its identity or source, in a manner that does not correspond to reality. 2. Imitating another Medical Product using the same artistic shapes and colours of the original product packaging, package, and label. 3. Adding or deleting one or more active or inactive ingredients from the composition stated on its packaging, package, identification card or internal leaflet without the approval of the EDE. 4. Changing the quantity or size of one or more of its active and inactive components without the approval of the EDE. Preliminary Materials: Materials used in the composition or manufacture of a Medical Product or any other products. Pharmaceutical Raw Materials: The basic components used in the pharmaceutical industry that aim to achieve the desired therapeutic effect when manufactured in a suitable Pharmaceutical Form. These materials include the chemical elements and active compounds that form the effective basis of the drug, in addition to inactive materials used to improve the form and properties of the drug, such as solvents and excipients of all kinds. Excipients and Solvents: Inactive ingredients used to improve the form and properties of a medicine Active ingredient: Any one or more substances responsible for the primary effects of a Medical Product, and which may be obtained from humans, animals, plants, microorganisms, chemicals, or other sources. Marketing Approval: The approval granted by the EDE to a legal entity licensed in the State to market a specific Medical Product. This legal entity shall be responsible for all aspects of marketing, promotion, and follow-up of the product in the State. Annex to the Marketing Approval: Attached to the Marketing Approval is a document containing all details related to the Medical Product, its description, the composition of the active and inactive ingredients and their quantities, uses, dosages, methods of use, side effects and any other details specified by the Decree-Law, its Executive Regulations and the decisions issued in implementation thereof. Product Brochure: A paper or electronic leaflet containing important and concise information for the Marketing Approval supplement intended for users of the Medical Product. The Main Effects of the Medical Product: The effects on the user of the Medical Product that are positive for its uses included in its Marketing Approval. New Use: A newly added use to the list of previously authorized uses of a Medical Product that has previously been approved for marketing in the State, provided that the new use results from effects separate from those basic effects of its previous uses. Approved Pharmacopoeia: A set of documents and standards that define the basic requirements for the quality of pharmaceutical and Pharmaceutical Products in the State and are concerned with providing precise guidelines for pharmaceutical manufacturing Establishments to ensure that Pharmaceutical Products produced in the State comply with strict standards of safety, effectiveness and quality. Pharmaceutical Form: The form of a Medical Product that is prepared or manufactured into its final form and taken by the patient. New Way to Use: A new method of administration of a Medical Product for which there is no previous Marketing Approval in the State in order to obtain the product main effects. Side View: The sum of the indications and symptoms documented in the product internal leaflet and expected to occur in some patients, which may appear in the patient while using the Medical Product in accordance with the uses, doses and methods of use stated on the packaging or card of the Medical Product or in its internal leaflet and specified in the Marketing Approval. Reverse Reaction: Any unintended or unwanted effect or symptom that appears in the user of the Medical Product within the doses documented in the internal leaflet and the uses authorized in the Marketing Approval and which occurs as a result of effects separate from those of the primary effects of the Medical Product. Opposite Event: An undesirable medical event that occurs to a user of a Medical Product or to a person exposed to a specific health intervention and which does not necessarily have a causal relationship with taking the product. It is also called an adverse effect if the Medical Product is a medical device. Adverse Reaction: Adverse reactions that are not expected to occur during the use of the Medical Product and whose nature or severity exceeds those documented in the Marketing authorization annex. Serious Side Effect or Serious Adverse Event: An undesirable medical event not intended for treatment that leads the user of the Medical Product or an adverse event, at any dose or by any method, to one or more of the following results: 1. Death. 2. Serious, life-threatening illness or injury. 3. Permanent or substantial impairment of body structure, body function, or organs. 4. Causing an abnormality, birth defect, disability or permanent impairment. 5. Chronic Disease. 6. Causing a life-threatening condition that requires hospitalization or prolonged hospitalization. 7. A medical or surgical intervention to prevent life-threatening disease or injury or permanent impairment of body structure, function, or organs. 8. Fetal distress, fetal death, congenital or organic malformation, or any negative effects on the fetus. Non Clinical Research: Pharmaceutical research and toxicity research to evaluate the safety of a Medical Product and its readiness for the Clinical Research stage that is not conducted on humans. This research yields preliminary information about the effectiveness, toxicity, effect of the drug in the body and its level of safety. It is conducted through laboratory experiments (test tube or cell culture In Vitro) or experiments on animals (in vivo experiments), or using computer models of interactions between the drug or the targeted treatment (In Silico). Clinical Research: It is research conducted on groups of people or the study of their data, samples, or tissues for understanding health and disease, for the most important reasons: 1. Explore the cause of a disease or group of symptoms. 2. Test effectiveness, efficiency and quality on a specific Medical Product that are conducted on groups of humans to determine how it is absorbed, metabolized, distributed, and eliminated from the body, to identify basic effects, side effects, and adverse interactions thereof. With the aim of confirming the effectiveness, efficiency, quality, and safety of using the Medical Product within the approved uses in accordance with the Marketing Approval granted to the Medical Product, or for new uses or drugs under research and development 3. Testing the effectiveness of a therapeutic procedure in treating symptoms or conditions. 4. Learn how a particular intervention or factor affects people health. Clinical Research consists of two basic types of research: 1. Clinical Trial. 2. Other Clinical Research: Any Research Projects that do not fall within Clinical Trials and include: a. Research Projects on humans that involve procedures for taking samples of biological material or collecting personal health data on individuals, such as health survey projects of various types. b. Research Projects involving the further use of biological materials or personal health data of individuals. c. Research Projects carried out on deceased persons. d. Research Projects carried out on stillbirth. Bioavailability: The speed, extent and availability of the active ingredient of a Medical Product or any of its active metabolites in the blood or at its site of action in the body. Bioequivalence: There is no statistically significant difference in the bioavailability of the active ingredient in a Pharmaceutical Product compared to another product with the same active ingredient. Research Information: Any information obtained as a result of research in chemistry, manufacturing, controls, Non-Clinical and Clinical Research to support the safety, efficacy and quality of a new Medical Product for Marketing Approval. Equivalent Alternative: A Pharmaceutical Product that is an alternative to another product and is therapeutically equivalent to it and provides the same therapeutic effect, benefits and drug safety limits for the patient in accordance with its approved uses. Stability Studies: Tests conducted under conditions similar to approved storage conditions or under conditions that are more severe than those used to increase the rate of chemical or physical degradation of the Medical Product in order to detect degradation reactions or any indications of unsuitability of the product in order to estimate the shelf life of the product under approved storage conditions. Batches: A specific quantity of a Medical Product that has been manufactured in a single batch and carries a unique identification number as well as a manufacturing date after passing the necessary inspection and testing stages. Product Withdrawal: The process of withdrawing a Medical Product in its entirety or a batch thereof due to a defect in the product or to confirm the validity of a complaint about an adverse reaction, a serious adverse event, or a serious side effect, or any other reasons explained by the party requesting the withdrawal. The withdrawal process is initiated by the producing factory, distributor, or importer or by order of the EDE. Reference Manuals: The State whose Marketing Approval of the Medical Product is relied upon to grant approval for its marketing in the State. Practitioner: A person who is scientifically and technically qualified and licensed to practice one of the health professions in the State, in accordance with what is specified in the Executive Regulations of this Decree-Law. Pharmacy Profession: One of the health professions that aims to improve the health level of users of Medical Products through their correct and rational use, based on specialized scientific knowledge. The pharmacy profession includes a number of licensed activities, which are manufacturing, compounding, dispensing, giving, selling or storing any Medical Product or providing pharmaceutical consultations, in addition to any other activities specified by a resolution of the Minister. It also includes providing a group of health care services to the patient directly or through supporting other licensed health care practitioners through communication and providing clinical advice (technical and scientific). Clinical Pharmacy: One of the Applications of the pharmacy profession based on specialized scientific knowledge to ensure that the patient benefits from the drug Treatment Plan to the maximum extent possible in his recovery, improving his health, or preventing him from diseases or complications, in order to practice the rational use of medicines. Qualified Person: A natural person who is scientifically and technically qualified and licensed to practice a specific activity within the field of the pharmacy profession or the medical profession in accordance with the provisions of this Decree-Law, its Executive Regulations, and the decisions issued in implementation thereof. Pharmacist: A person who holds an academic qualification of no less than a Bachelor degree in Pharmacy or its equivalent from a higher institute, college or university recognized in the State and who is licensed to practice the profession of pharmacy in the State in accordance with the provisions of this Decree-Law, its Executive Regulations and the decisions issued in implementation thereof. Pharmacist in Charge: The licensed Pharmacist in the licensed Pharmaceutical Establishment, who shall be responsible for implementing the provisions of this Decree-Law, its Executive Regulations, and the decisions issued in implementation thereof, within the scope of the tasks assigned to him. Precautionary Closure: A precautionary measure taken by the Inspector of a Pharmaceutical Establishment or Biobank in the event of a serious violation that may harm public health. Clinical Pharmacist: A person who holds accredited scientific degrees in clinical pharmacology and has extensive experience in this field and specializes in developing Treatment Plans for patients, including the use of Medical Products based on scientific analysis of the patient condition and reports on the diagnosis of his condition. He is also committed to providing specialized professional advice on the patient drug Treatment Plan and the optimal use of Medical Products to all healthcare professionals who are members of the health team responsible for the patient and to the patient himself. Medical Equipment Engineer: A person who holds an academic qualification of no less than a Bachelor degree in Medical Engineering or Medical Technology Engineering. Prescription: A document transmitted in writing or electronically and issued by a practitioner of a health profession who is legally licensed to prescribe to a practitioner of a health profession who is authorized to dispense or handle in accordance with what is specified in the Executive Regulations of this Decree-Law and the decisions, regulations and instructions issued in this regard. The verbal order issued by a practitioner of a health profession shall be considered a medical prescription, provided that it is subsequently documented in accordance with a resolution of the Minister. Treatment Plan: The plan for the use of Medical Products designed based on a careful analysis of the patient medical condition and the patient situation to obtain the best possible results for his treatment and includes the schedule for taking the products specified by name, type, Pharmaceutical Form, strength, method of use, single dose amount, number of doses per day, term of treatment and any other instructions such as the sequence of use of the products or gradual dose adjustment and the like. Medical Product Use (Protocol): The law approved by the Health Establishment or the treating physician, which specifies the medical conditions in which the Medical Product may be used, the warnings concerning the prohibition of its use, and the conditions for determining the sequence of use of the product, the dosage, the term of treatment, and the method of use. Patient Treatment Guide: The system that governs how to proceed with the treatment of a specific medical condition in accordance with precise instructions describing the diagnostic conditions for the medical condition and specifying the Medical Products and other therapeutic procedures for each condition and the sequence of their use or employment. Direct Supervision and Control: Full knowledge and complete monitoring at all times of all activities carried out by the employees of the Pharmaceutical Establishment or Biobank. Establishment: Establishment licensed to work in any of the fields of pharmacy and Medical Products in the State, including: 1. General pharmacies and Pharmacy Chains. 2. Non-Clinical and Clinical Research entities 3. Bioequivalence centers 4. Pharmaceutical labs. 5. Factories and Contracting Companies to manufacture medical products. 6. Contractual Company for Research and Development 7. Marketing Offices. 8. Pharmaceutical Consulting Offices. 9. Compound Pharmacies. 10. Medical Warehouses and Medical Stores. General Pharmacy: A Pharmaceutical Establishment licensed to store, prepare, dispense, display or sell Medical Products directly to the public, through a fixed or mobile, permanent or temporary Establishment, or through a health Establishment. Pharmacy Chain: A group of pharmacies owned by one natural or legal person and bearing the same name. Compound Pharmacy: A Pharmaceutical Establishment licensed to prepare medical preparations based on medical prescriptions or to meet the needs of Health Establishments for the necessary synthetic products. Medical Warehouse: The Pharmaceutical Establishment licensed to store and possess the Medical Product or pharmaceutical raw materials and supplies. The warehouse may be licensed for import, distribution, re-export, or any other activities in accordance with the geographical location of the Establishment, as determined by the Executive Regulations of this Decree-Law. Medical Store: A Pharmaceutical Establishment licensed to store Medical Products without the right to possess or dispose of them and provide logistical services, and does not have the right to trade or distribute for sale. Marketing Office: A Pharmaceutical Establishment licensed to practice the activity of introducing Medical Products to healthcare professionals and monitoring their circulation in the State. Pharmaceutical Consulting Office: A Pharmaceutical Establishment licensed to practice the activity of providing specialized and practical consultations in the field of pharmacy profession applications, in accordance with what is specified in the Executive Regulations of this Decree-Law. Medical Products Factory: A Pharmaceutical Establishment intended to manufacture Medical Products, in whole or in part. Pharmaceutical Laboratory: A Pharmaceutical Establishment licensed to carry out various laboratory analysis operations for Medical Products, including stability studies and quality tests, in accordance with the specifications and controls specified for them by the requesting party. Contractual Company for Research and Development: Companies contracted to outsource and accelerate the processes of innovation, development, and manufacturing of Medical Products. Including: 1. Contract Research Organizations: A person or company that is contracted to carry out one or more of the obligations of a Clinical Trial sponsor. 2. Contract Site Management Organizations: A person or company that is contracted to provide administrative services related to the management of Clinical Trial sites, and shall not bear any of the regulatory obligations of the Clinical Trial sponsor. It may have a network of Clinical Research sites managed thereby, and its services include: identifying or managing principal and secondary researchers, recruiting study staff, preparing submissions to institutional review committees and boards, assisting in project feasibility, patient recruitment, study site launch and close-out, or any other study-related activities at the study site. Contract Manufacturing Company: A company that is contracted by major pharmaceutical companies to outsource and accelerate medical product manufacturing processes and provide end-to-end services from development to manufacturing of the medical product, which can aid in scalability or can allow the major company to focus on drug discovery and drug marketing. The services shall include: Pre-product development services, technical studies related to the product, materials, manufacturing methods, registration, and commercial production. Biobank: An establishment licensed to collect, preserve, store and distribute biological samples such as, but not limited to, blood, tissues and cells, and related information for future use, including but not limited to independent and mobile blood banks, umbilical cord blood banks and stem cell storage centers. Biological Sample: Any type of sample of biological material taken from a living organism - such as blood, serum, urine, skin, muscle, and organ tissue samples, as well as cell cultures and DNA samples. Bioequivalence Centre: A licensed Pharmaceutical Establishment where comparative research and studies are conducted to determine the Bioequivalence of a generic drug compared to an innovative drug. Storage: The process of keeping a Medical Product at any time during its life cycle in manufacturing and distribution channels. Manufacturing: A set of activities related to the manufacture of a Medical Product, from purchasing raw materials and products in its manufacture, to its production processes, such as preparation, composition, derivation, packaging, repackaging, quality control, approval, etc. Distribution: Transporting or moving the Medical Product from the premises of the producing factory or any other central point to the end user or to any intermediate center between them, using equipped means of transport. Import: Importing Medical Products in their final form or raw materials from outside the State or its free zones to the mainland or within the State through customs ports and after obtaining permit or approval from the EDE for each shipment. Export: Exporting locally manufactured medical products or their raw materials from the State through customs ports and after obtaining permit or approval from the EDE for each shipment. Re-export: Exporting medical products or pharmaceutical raw materials that were previously officially imported through customs ports and after obtaining permit or approval from the EDE for each shipment. Import or Export Permit: The permit issued by the EDE to the Medical Warehouse licensed to import and export Medical Products or to the licensed medical factory after fulfilling the conditions stipulated in accordance with the provisions of this Decree-Law, its Executive Regulations and the decisions issued in implementation thereof. Import or Export Approval: The approval granted by the EDE to a specific Establishment or entity to import or export specific or essential Medical Products required to perform its duties, and not for commercial purposes, in cases specified by a decision from the President. Importer: A legal person licensed to import any quantity of Medical Products from outside the State for possessing, storing, distributing or selling them in bulk. Distributor: A legal person licensed to practice any activity related to the circulation of a Medical Product, except for import and direct sale to the public. Marketing Rights Holder: The holder of a license to market one or more Medical Products in the State, in accordance with the provisions of this Decree-Law, its Executive Regulations, and the decisions issued in implementation thereof, and shall be responsible for the aspects of its marketing, promotion, and follow-up in the State. Lab Study: The study and research conducted on one or more Medical Products or their components within the scope of the laboratory and laboratory tests to determine their toxic, chemical, physical, microbiological, biological or technical properties, which do not include experiments on humans and can be tested on animals. Controlled Materials and Products: Products and materials for which medical and commercial circulation require special control procedures are: 1. Toxic substances and plants. 2. Prohibited veterinary substances. 3. Narcotic and psychotropic substances, whether in the form of raw materials or in a Medical Product. 4. Hazardous Medical Products. Toxic Substances and Plants: Materials and plants specified in accordance with the legislation regulating this type of materials and plants. Prohibited Veterinary Substances: Materials specified in accordance with the legislation regulating this type of materials. Narcotics and Psychotropic Substances: Medical, pharmaceutical and other products containing any of the active ingredients in accordance with Federal Law No. (30) of 2021 on Psychotropic Substances referred to, and its amendments. Semi-Controlled Products: Substances or drugs that are not classified as narcotic or psychotropic substances, but circulation thereof in the State shall be controlled because their misuse may lead to harm to public health. Hazardous Medical Products: Products whose definition and prohibited uses are determined by a decision issued by the President or his delegate. Chemical Precursors: A chemical substance that is used in any stage of the manufacturing or production of narcotic or psychotropic substances, Hazardous substances, psychoactive substances, or toxic substances, In accordance with the two lists attached to this Decree-Law and any subsequent amendments thereto. Exclusive Marketing: Approval to market specific Medical Products to specific entities within the State, without the need to issue a Marketing Approval. Pharmacovigilance: It is the science that accompanies activities related to identifying side effects, adverse reactions or toxicity of Medical Products and the potential risks of their use, methods of monitoring and controlling them, and collecting these reports for evaluating, analyzing, treating and preventing them, and determining ways to prevent their occurrence. Grey Market: Circulation Medical Products through distribution channels that are not recognized by the original manufacturer, or are not licensed.
Interpretation and application must be checked against the official text and current version.