Medical Products, Pharmacy Profession and Pharmaceutical Establishments Law

Article (1) Definitions

Part One: General Provisions

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.

Article (2) Decree-Law Scope of Application

Part One: General Provisions

The provisions of this Decree-Law shall apply to the following products, professions, and establishments: 1. Hazardous Medical Products: a. Pharmaceutical Products. b. Medical Equipment. c. All Pharmaceutical Products. d. Health Care Products; e. Biopharmaceutical Products; f. Food Supplements; g. Cosmetics. h. Genetically modified organism products intended for medical use. 2. Chemical precursors, controlled, semi-controlled, hazardous and toxic products and substances, whether for human or veterinary use. 3. Pharmacy profession for state employees including free zones. 4. Pharmaceutical Establishments and Biobanks operating in the State, including those operating in free zones. 5. Any other Pharmaceutical Establishments for which a decision is issued by the Cabinet.

Article (3) Approved Pharmacopoeia

Part Two: Regulation and Circulation of Medical Products

The EDE, in coordination with the Competent Health Authority, shall prepare, publish and update the State Pharmacopoeia. The EDE shall also approve reference Pharmacopoeia.

Article (4) Exclusive Marketing Approval

Part Two: Regulation and Circulation of Medical Products

1. The EDE may grant approval for the exclusive marketing of a Medical Product in accordance with the controls and conditions specified in a decision issued by the BOD. 2. The Medical Product subject to exclusive marketing may not be manufactured, imported, distributed, possessed, sold or used in the State unless the approval for exclusive marketing has been obtained from the EDE.

Article (5) Marketing Approval

Part Two: Regulation and Circulation of Medical Products

1. Without prejudice to the applicable legislation concerning veterinary preparations, it is not permitted to import, distribute, possess, sell, display, re-market, use, or manufacture any Medical Product in the State for circulation therein, except after obtaining Marketing Approval of any type from the EDE. 2. As an exception to Clause (1) of this Article, all categories of Medical Products that are compounded in licensed compounding pharmacies are exempt from the requirement to obtain Marketing Approval. 3. The Cabinet may, upon the proposal of the President, decide to exempt any other Medical Products from the requirement to obtain Marketing Approval for their circulation.

Article (6) Terms and Conditions for Granting Marketing Approval

Part Two: Regulation and Circulation of Medical Products

1. The Marketing Approval for the Medical Product is issued by the EDE in accordance with the following conditions: a. The Applicant shall be a Pharmaceutical Establishment licensed as a Marketing Office, a Medical Products Manufacturer, a contracted Medical Products manufacturing company, or a Medical Warehouse designated by the Marketing Rights holder. b. The Applicant shall implement a quality assurance and product traceability system, a pharmacovigilance system and post-marketing follow-up. c. Assessing the Medical Product compliance with the Marketing Approvals issued for it by the reference countries or its compliance with research information that proves its effectiveness, safety of use, and conformity with approved quality specifications, including the results of clinical assessment or Bioequivalence and post-marketing results to prove the safety and effectiveness of the Medical Product. d. The presence of a certificate of analysis for Medical Products in Pharmaceutical Form or a quality certificate for their batches proving their quality or safety from a laboratory licensed by the EDE or approved by it. e. The Applicant has the right to market it in accordance with the established rules for intellectual property and trademarks. If the Medical Product is similar, the Applicant shall ensure compliance with the applicable laws and regulations concerning the protection of intellectual property and trademarks and provide evidence of the use of information and data for innovative products. f. Submit a valid Good Manufacturing Practice Certificate from the EDE and/or from the Competent Authority in the State of origin and/or any of the reference bodies accredited by the EDE. g. All information and data on the Medical Product and how to use it are provided on the internal and external card and the paper or electronic leaflet for the Medical Product, and the product meets the labelling guidelines issued by the EDE. h. Any other conditions determined by the Executive Regulation of this Decree-Law. 2. Without prejudice to the provisions of international agreements to which the State is a party, and to the provisions of the intellectual property legislation in force in this regard, the EDE may grant Marketing Approval for a similar product, based on its biological and qualitative equivalence with a Pharmaceutical Product for which the legal protection granted has ceased, and for which Marketing Approval has previously been issued in accordance with the provisions of this Decree-Law. 3. The EDE shall record the Medical Product for which Marketing Approval has been issued in the database referred to in Article (66) of this Decree-Law. 4. The Executive Regulations of this Decree-Law shall specify the conditions, requirements and other controls for granting Marketing Approval, classified in accordance with the type of Medical Product and whether it is a similar, innovative, pioneering or orphan Pharmaceutical Product.

Article (7) Marketing Approval Validity and Renewal Term

Part Two: Regulation and Circulation of Medical Products

1. The Marketing Approval shall be valid for a period of (5) five years, and shall be renewed for similar periods in accordance with the terms and rules governing this in the Executive Regulations of this Decree-Law. 2. The request to renew the Marketing Approval shall be submitted ninety (90) days before its expiration date. 3. The Marketing Right Holder may not continue the activity permitted in the Marketing Approval issued for the specific Medical Product after the expiry date of the Marketing Approval and until its renewal, unless the EDE deems otherwise. The EDE may authorize the Marketing Right Holder to continue the activities related to some Medical Products if necessary. 4. The EDE may grant Marketing Approval for a period less than the period referred to in Clause (1) of this Article, in accordance with the controls specified in the Executive Regulations of this Decree-Law.

Article (8) Conditional Marketing Approval

Part Two: Regulation and Circulation of Medical Products

Without prejudice to the applicable legislation concerning intellectual property, the EDE may issue conditional Marketing Approval for the following Medical Products: 1. Orphan medical or biological products for the treatment of rare diseases that have been provisionally approved globally by some reference Health Authorities. 2. Medical Products for the treatment of life-threatening and serious diseases, the use of which results in significant therapeutic benefit, and no alternative, equivalent or authorized Medical Product is available in the State. 3. Medical Products that are not available in the State and for which there is no equivalent alternative. 4. Any other products determined by the Executive Regulations of this Decree-Law.

Article (9) Terms and Controls of Conditional Marketing Approval

Part Two: Regulation and Circulation of Medical Products

1. The Conditional Marketing Approval for the Medical Product is issued by the EDE in accordance with the following conditions: a. Fulfilling the conditions referred to in paragraphs (a, b, d, g) of Clause (1) of Article (6) of this Decree-Law. b. Assessing the Medical Product compliance with the Marketing Approvals issued to it by the reference countries, or providing complete information and data concerning the reasons and justifications for the Medical Product obtaining conditional Marketing Approval from the reference country or one of the global reference Health Authorities for assessment. c. Submitting an undertaking stating that the Application for the Marketing Approval referred to in Article (5) of this Decree-Law will be submitted immediately after the reasons and justifications that called for the request for conditional Marketing Approval have expired, and in the event that the Marketing Right Holder wishes to continue circulation the Medical Product after the expiry of these reasons and justifications. d. Any other conditions determined by the Executive Regulation of this Decree-Law. 2. The Conditional Marketing Approval for the Medical Product is issued by the EDE in accordance with the following controls: a. The use of Medical Products that have received conditional Marketing Approval on specific persons or groups of persons without the need to conduct Clinical Trials. b. Marketing Medical Products that have been granted conditional approval to fill the temporary shortage of a similar Medical Product licensed in the State, provided that the Medical Product is licensed in another country that has similar control over Medical Products, and there is no identical, licensed and available Medical Product in the State. c. Any other controls determined by the Executive Regulation of this Decree-Law. 3. The EDE shall record the Medical Product for which Marketing Approval has been issued in the database referred to in Article (66) of this Decree-Law.

Article (10) Conditional Marketing Approval Validity and Renewal Term

Part Two: Regulation and Circulation of Medical Products

1. Conditional Marketing Approval shall be valid for one year and is renewable for similar periods if the reasons and justifications for requesting conditional Marketing Approval continue. 2. The request to renew the conditional Marketing Approval shall be submitted ninety (90) days before its expiration date. The renewal shall be made in accordance with the same terms and conditions specified for its first issuance, if the reasons and justifications for requesting the conditional Marketing Approval continue. 3. The Entity submitting the conditional Marketing Approval request may not continue to practice the activity mentioned in the conditional Marketing Approval after its expiry date and until its renewal. 4. The EDE may grant Conditional Marketing Approval for a period less than the period referred to in Clause (1) of this Article, in accordance with the controls specified in the Executive Regulations of this Decree-Law. 5. If the Marketing Right Holder desires to continue trading the Medical Product after the expiry of the conditional marketing approval period and the expiration of the reasons and justifications calling for its submission, he shall submit a request to obtain the Marketing Approval referred to in Article (5) of this Decree-Law.

Article (11) Emergency Use Approval

Part Two: Regulation and Circulation of Medical Products

Without prejudice to the applicable legislation on intellectual property and as an exception to the terms and conditions for granting Marketing Approval, the EDE may issue Emergency Use approval for some Medical Products required by the State in the event of a health emergency, epidemic or health pandemic that is announced in accordance with the applicable legislation in this regard.

Article (12) Controls and Conditions of Emergency Use Approval

Part Two: Regulation and Circulation of Medical Products

1. Approval for Emergency Use of a Medical Product shall be issued in accordance with the following conditions: a. There is evidence of the effectiveness of the Medical Product in diagnosing, treating or preventing the diseases involved in the emergency health condition. b. Providing evidence that the known and potential benefits of the Medical Product outweigh its risks. c. The lack of adequate, approved and available alternatives to the Medical Product for the diagnosis, prevention or treatment of the diseases involved in the emergency health condition. d. The presence of data from Clinical Research, Clinical Trials or any other reference sources that prove the safety and effectiveness of the Medical Product. e. Having a plan in place to monitor the use of the Medical Product and manage any risks associated with its use. f. Any other conditions determined by the Executive Regulation of this Decree-Law. 2. Approval for Emergency Use of a Medical Product shall be issued in accordance with the following controls: a. Pharmaceutical and Health Establishments in the State that handle the Medical Product that has received Emergency Use approval shall comply with the instructions issued by the EDE concerning uses and dosages. b. Any other controls determined by the Executive Regulation of this Decree-Law. 3. As an exception to Clause (2) of Article (6), and in the event that the State is exposed to a health pandemic that is declared in accordance with the legislation in force in this regard, the EDE may grant approval for Emergency Use and a permit to import the similar product before the expiration of the legal protection period for the reference innovative product.

Article (13) Term of Emergency Use Approval and Renewal

Part Two: Regulation and Circulation of Medical Products

1. The approval for Emergency Use of the Medical Product shall be valid for the term of the State of health emergency declared by the State, and until it issues another declaration stating the end of the State of emergency, unless another period is specified by the EDE. 2. The EDE may review its Emergency Use authorization and consider revoking it based on new evidence or changes in the health emergency situation. 3. The EDE may extend the validity period of the Emergency Use approval issued by it or renew it for periods determined by it if the health emergency continues and the Medical Product continues to meet the necessary standards. 4. The Entity submitting the Emergency Use approval request may not continue to practice the activity mentioned in the Emergency Use approval after its expiration date. 5. Submit an undertaking stating that the Application for the Marketing Approval referred to in Article (5) of this Decree-Law will be submitted immediately after the reasons and justifications that called for the request for conditional Marketing Approval have expired, and in the event that the Marketing Right Holder wishes to continue circulation the Medical Product after the expiry of these reasons and justifications.

Article (14) Fast Track Marketing Approval

Part Two: Regulation and Circulation of Medical Products

1. The EDE establishes a fast track with simplified procedures in line with quality, safety, efficacy requirements and international agreements, to grant Marketing Approvals for innovative Medical Products of therapeutic importance. 2. The Executive Regulations of this Decree-Law shall specify other Medical Products permitted to be included in the fast track and the terms, controls and requirements for submitting a request for Marketing Approval within this track.

Article (15) Resubmission of Marketing Approval and Conditional Marketing Approval

Part Two: Regulation and Circulation of Medical Products

The Marketing Approval or conditional Marketing Approval issued by the EDE is considered invalid and the Marketing Right Holder may not use it. He shall reapply for a new Marketing Approval or conditional Marketing Approval for the same Medical Product, in any of the following cases: 1. Substantial changes in the composition or formulation of a Medical Product. 2. Significant changes in dosage form or concentration. 3. Changes in the classification of the Medical Product type or its route of administration, which were not included in the current Marketing Approval or conditional Marketing Approval. 4. Significant changes in the manufacturing and production process that may affect the quality, safety or effectiveness of the Medical Product. 5. Fundamental changes in medical device design. 6. Voluntarily withdraw a Medical Product from the market for later re-introduction with significant changes. 7. Results of pharmacovigilance operations, whether due to new safety concerns or reports of adverse reactions or medical events that require withdrawal or re-assessment and significant changes to the Medical Product. 8. Any other cases determined by the Executive Regulation of this Decree-Law.

Article (16) Approval of Minor Changes to the Medical Product

Part Two: Regulation and Circulation of Medical Products

The Marketing Right Holder shall submit a request for minor changes to the Medical Product to the EDE without the need to submit a new request for Marketing Approval of all types as referred to in Article (15) of this Decree-Law, in any of the following cases: 1. Any minor changes in the composition of the Medical Product or in the event of new uses for the Medical Product, whether as new indications for use or suitability for a new category of patients. 2. Any change in the appearance of the Medical Product or its internal leaflet. 3. Any change in the location of the Medical Product manufacture or in the Marketing Rights holder, or minor changes in the method of its manufacture. 4. Any other cases determined by the Executive Regulation of this Decree-Law.

Article (17) Cancellation of All Types of Marketing Approval or Cancellation of Emergency Use Approval and Transfer of Ownership Thereof

Part Two: Regulation and Circulation of Medical Products

1. The EDE may issue a decision to cancel the Marketing Approval, conditional Marketing Approval, or approval for Emergency Use of a Medical Product in the State in any of the following cases: a. The locally manufactured Medical Product has not been put on the market within (2) years from the date of granting Marketing Approval without an excuse acceptable to the EDE. b. The locally manufactured Medical Product has not been put on the market within one year from the date of granting Marketing Approval without an excuse acceptable to the EDE. c. The Medical Product that has obtained Emergency Use approval or conditional Marketing Approval has not been placed on the market within (3) three months from the date of granting it without an excuse acceptable to the EDE. d. The unavailability or absence of the Medical Product in the market for (2) consecutive years after its introduction to the market without an excuse acceptable to the EDE. e. If it is proven that Marketing Approval of any kind or Emergency Use approval was obtained based on incorrect documents. f. If a decision is issued requiring a ban on the manufacture, distribution or circulation of the Medical Product in the State, the State of origin or any of the reference bodies approved by the EDE. g. If it is proven that the Medical Product Manufacturer or the contracted company for manufacturing Medical Products has repeatedly failed to apply the principles of good manufacturing practice or the principles of good storage and distribution, which affects the quality of the Medical Product. h. If the Medical Product is proven to be unsafe or unsafe, or repeatedly fails to comply with approved quality standards, when laboratory tests are conducted in the EDE quality control laboratory. i. If the Medical Product is proven to be unsafe due to new safety concerns or reports of adverse medical reactions or events that may require the Medical Product to be withdrawn. j. If a decision is issued requiring the prohibition of the activity of a Medical Products Manufacturer, a contracted company for the manufacture of Medical Products, a Medical Warehouse in the State, the Entity represented by the Marketing Office in the State of origin, or any of the reference bodies approved by the EDE. k. The Executive Regulations of this Decree-Law shall specify any other cases that require the cancellation of Marketing Approval of all types or approval for Emergency Use. 2. With the approval of the EDE, Ownership of the Marketing Approval or conditional Marketing Approval for a Medical Product may be transferred to other parties, in accordance with the terms and conditions specified in the Executive Regulations of this Decree-Law.

Article (18) Protect Intellectual Property

Part Two: Regulation and Circulation of Medical Products

Without prejudice to the applicable legislation concerning intellectual property, documents and data related to an innovative Medical Product and a Medical Product with at least one new active ingredient, whether developed in the State or imported, are subject to a protection period. The Executive Regulations of this Decree-Law shall specify the period, mechanism and system related to regulatory protection.

Article (19) Scientific Fraud

Part Two: Regulation and Circulation of Medical Products

Pharmaceutical Establishments licensed to manufacture, market or distribute the Medical Product or provide pharmaceutical consultations shall refrain from any distortion, fraud, theft or scientific plagiarism of published studies and research, in a manner that affects the legal rights established for the Owners of these studies and research.

Article (20) Product Pricing

Part Two: Regulation and Circulation of Medical Products

The Marketing of a Medical Product that has obtained Marketing Approval requires the existence of a specific price for this product, which is determined in accordance with the general rules issued by a decision of the BOD.

Article (21) Marketing Rights Holder Obligations

Part Two: Regulation and Circulation of Medical Products

The Applicant for Marketing Rights or his representative for marketing Medical Products shall undertake the following: 1. Appoint one or more qualified persons residing in the State, in accordance with the controls specified in the Executive Regulations of this Decree-Law. 2. Fulfil the conditions mentioned in Article (22) of this Decree-Law 3. Monitor the movement of the Medical Product in the distribution channels. 4. Provide the required capabilities and systems to follow up on the requirements for obtaining Marketing Approval, conditional Marketing Approval, Emergency Use approval, or exclusive Marketing Approval for the Medical Product. 5. Monitor the performance of the Medical Product licensed for marketing, and receiving reports from Health Establishments concerning the effectiveness, safety and quality of the product. 6. Comply with the guides and standards issued by the EDE concerning pharmacovigilance, and to implementing the provisions of Clause (3) of Article (68) of this Decree-Law. 7. Follow up on the procedures for withdrawing the Medical Product. 8. Follow up on patent protection and manufacturing rights issues for the product.

Article (22) Appointment of Pharmaceutical Establishments

Part Two: Regulation and Circulation of Medical Products

1. The Marketing Right Holder shall appoint at least two Pharmaceutical Establishments licensed by the EDE to import Medical Products into the State as importers of the Medical Product for which he has obtained the Marketing Right, and shall appoint one or more Pharmaceutical Establishments licensed in the State to distribute the Medical Product for which he has obtained the Marketing Right, in accordance with the following controls: a. The Marketing Right Holder shall inform the EDE of the designation of one main Pharmaceutical Establishment from the Pharmaceutical Establishments designated by the Marketing Right Holder to undertake all product licensing work, pharmacovigilance activities and management of the entire life cycle of the Medical Product. b. One application shall be submitted by the Pharmaceutical Establishment specified in paragraph (A) of item (1) of this Article, to obtain Marketing Approval of all types for each Medical Product, regardless of the number of designated Pharmaceutical Establishments. c. All designated Pharmaceutical Establishments are required to carry out import operations of Medical Products during the calendar year. 2. The holder of the local Marketing Right for locally manufactured Medical Products shall appoint one or more Pharmaceutical Establishments licensed in the State to store and distribute the Medical Product for which he has obtained the Marketing Right, either by establishing Establishments dedicated to this purpose at the local factory licensed by the EDE or by appointing one or more Pharmaceutical Establishments to carry out these tasks. 3. Any other controls or conditions determined by the Executive Regulation of this Decree-Law. 4. The Cabinet may exempt the Marketing Right Holder from the Application of the provisions of this Article based on the proposal of the President, and in accordance with the controls that it determines.

Article (23) Obligations of the Appointed by the Marketing Rights Holder

Part Two: Regulation and Circulation of Medical Products

The qualified person appointed by the Marketing Right Holder shall undertake the following: 1. Providing pharmaceutical or scientific information about the marketed Medical Product to Health Establishments, ensuring its accuracy and conformity with the information approved by the EDE. 2. Inform the EDE of any change or update in the manufacturing or composition methods, the source of the active ingredients, the form, packaging, or qualitative testing methods of the Medical Product, or any new use of the Medical Product or any change, update, addition, or deletion of the uses specified within the Marketing Approval to obtain its approval, and the EDE is obligated to make available data and information about the changes after their approval in accordance with the mechanisms approved by it. 3. Comply with the provisions of the guides and standards issued by the EDE concerning pharmacovigilance, and implementation of the provisions of Clause (3) of Article (68) of this Decree-Law. 4. Follow up on post-marketing reports on the Medical Product, reports on its effectiveness, safety of use and quality during its circulation in Health Establishments in the State.

Article (24) Civil Liability

Part Two: Regulation and Circulation of Medical Products

The qualified person shall be responsible, together with the Marketing Right Holder, for any violations of the provisions of this Decree-Law, especially with regard to maintaining all records and records related to the activity of circulation the Medical Product.