Medical Products, Pharmacy Profession and Pharmaceutical Establishments Law — articles 1–100

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:…

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…

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

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 marketi…

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 fo…

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 Produ…

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. …

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 trea…

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…

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 con…

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…

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 d…

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 emergen…

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…

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 Appro…

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 De…

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…

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 develop…

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 publishe…

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 BO…

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 speci…

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 Marke…

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 …

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 a…

1. Non-Clinical Research on humans is prohibited, and the Executive Regulations of this Decree-Law shall specify the controls for conducting non-Clinical Research. 2. It is prohibited to conduct any Clinical Trials befor…

A laboratory study, product analysis certificate or quality certificate for a batch or batches of a Medical Product may not be accepted as a document authorizing its quality, stability or safety unless it has been conduc…

No Medical Product may be manufactured in the State for marketing therein, except after obtaining Marketing Approval from the EDE, provided that it is manufactured in a factory licensed in the State, in accordance with t…

The BOD shall issue, by decision, rules, guidelines and standards of good practice that are consistent with internationally recognized guidelines and standards, in order to ensure the quality, efficiency and safety of Ph…

1. Excipients and solvents may not be loaned or transferred between licensed factories in the State except with the approval of the EDE and in the cases it permits, provided that this does not prejudice the specification…

A system of incentives and benefits to attract investment and support innovation and development in the medical industries sector shall be issued by a resolution of the Cabinet, based on the proposal of the President and…

1. It is not permitted to import, export or re-export any Medical Product or any raw materials or pharmaceutical raw materials used in its manufacture except after obtaining approval or permit from the EDE. 2. The cases …

1. The approval or permit to import, export or re-export Medical Products, raw materials or pharmaceutical raw materials shall be issued by the EDE in accordance with the following conditions: a. The existence of any typ…

1. The EDE shall issue a decision to cancel the approval or permit issued by it to import, export or re-export the Medical Product, raw materials or pharmaceutical raw materials, in any of the following cases: a. If it i…

1. A clearance certificate shall be obtained from the EDE for each batch of certain vital products that require compliance with safety, quality and efficacy standards, either after they are manufactured in the State or f…

The Executive Regulations of this Decree-Law shall specify the conditions, rules and controls for bringing, possessing or obtaining a Medical Product with any person upon entering or leaving the State for personal use, o…

Pursuant to this Decree-Law, a committee called the “Pharmaceutical Policy Committee” shall be established, reporting to the President, and shall be responsible for proposing policies related to the circulation, pricing,…

1. None of the following categories may refuse to provide a Medical Product that has obtained Marketing Approval in accordance with the provisions of this Decree-Law, in an illegal manner or with the intent to monopolize…

1. No Medical Product may be traded or marketed unless the information and data recorded on the internal and external card and the paper or electronic leaflet for the Medical Product are identical to the information and …

1. It is prohibited to trade in counterfeit, defective or expired Medical Products. 2. The sale of free advertising samples of Medical Products is prohibited, and the outer and inner cards of these samples shall be clear…

Non-Pharmaceutical Establishments are prohibited from importing, marketing, selling, displaying, storing or circulation any Medical Product that requires a prescription for dispensing.

The Executive Regulations of this Decree-Law shall specify the types of establishments other than pharmaceuticals that are permitted to market, sell, display, store or trade Medical Products that are dispensed without a …

1. Physicians may not prescribe a Medical Product for new uses not specified in the internal leaflet or electronic leaflet, or prescribe a Medical Product that has not been submitted for Marketing Approval, except when n…

The EDE shall issue the National Policy for the Strategic Stock of Medical Products after its approval by the Cabinet. The EDE shall be responsible for its management and follow-up of its implementation at the federal an…

1. It is prohibited to advertise, publicize or promote Medical Products by any means, whether visual, written, audible or on social media, unless approved by the EDE. 2. Advertising, publicity or promotion to the public …

The approval for advertising, publicity or promotion of Medical Products shall be issued by the EDE in accordance with the following conditions: 1. Valid Marketing Approval from the EDE for the Medical Product to be adve…

The approval to advertise the Medical Product issued by the EDE shall be valid for a period ranging from (30) thirty days to one year, depending on the Applicant desire. The Applicant shall obtain a new approval for each…

1. The EDE shall issue a decision to cancel the approval issued by it to advertise the Medical Product during its validity period (the advertisement through all means in which it was published, whether visual, written, a…

It is prohibited to destroy or safely dispose of Medical Products, except after obtaining approval from the Competent Health Establishment or Authority, each within the limits of their jurisdiction.

1. Approval for the destruction or safe disposal of Medical Products shall be issued by the Competent Health Establishment or Authority, each within the limits of its jurisdiction in accordance with the following conditi…

1. The approval for the safe destruction and disposal of the Medical Product shall be valid for the period determined by the Competent Health Establishment or Authority, each within the limits of their jurisdiction. 2. T…

1. The Competent Health Establishment or Authority, each within the limits of their jurisdiction, shall issue a decision to cancel the approval issued by it for the safe disposal or destruction of the Medical Product and…

Subject to the provisions of any other legislation: 1. It is not permitted to install any Medical Product that is not included in a medical prescription that meets the conditions specified in this Decree-Law. 2. It is no…

The controls related to the storage and circulation of controlled materials and products shall be determined by a decision of the Chairman or his delegate, in coordination with the Ministry, the Competent Health Authorit…

Subject to the provisions of Article (55) of this Decree-Law, it is prohibited to possess controlled materials and products except by virtue of a license issued by the competent institution, Ministry or Health Authority …

The Pharmacist Responsible for controlled substances and products in the pharmacy may not dispense controlled substances or products for medical use except in any of the following cases: 1. For patients, by prescription …

The circulation of controlled materials and products between licensed Pharmaceutical or Health Establishments requires obtaining the approval of the Competent Authority, Ministry or Health Authority. in accordance with t…

1. Pharmaceutical Establishments may not import controlled materials and products or their raw materials or pharmaceutical raw materials for their active ingredients except after the approval of the EDE based on a reques…

The person responsible for the custody of controlled materials and products in any of the categories specified in Article (54) of this Decree-Law shall conduct a periodic inventory of this custody and inform the EDE, Min…

1. Without prejudice to the provisions of international agreements to which the State is a party, hazardous or toxic medical materials and products may not be traded except in accordance with the controls issued by a dec…

If the Establishment that has been issued a permit to possess controlled materials and products stops working or the person responsible for it relinquishes custody of it for any reason, the person responsible for the Est…

The list of semi-controlled medical materials and products and the terms and conditions for their circulation shall be determined by a decision of the Chairman or his delegate, in coordination with the Ministry, the Comp…

1. Without prejudice to international agreements to which the State is a party or any other law, two lists of chemical precursors used in the manufacture of Medical Products are attached to this Decree-Law. 2. The two li…

1. It is prohibited to bring, import, export, manufacture, extract, separate, produce, possess, distribute, use in the manufacture or trade of chemical precursors without obtaining permit from the EDE. 2. The Cabinet sha…

1. It is prohibited to bring, import, export, manufacture, extract, separate, produce, possess, distribute, use or trade in chemical precursors used for non-medical purposes without the permit of the Ministry of Interior…

1. The EDE, in coordination with the Competent Health Authority, shall establish a National System for the circulation, tracking and coding of Medical Products from the factory to the end user. The EDE shall manage this …

1. A national database for Medical Products shall be established in the EDE, in which all data and information related to Medical Products, their technical specifications, pricing and other data shall be recorded and sto…

The mechanism of the system operation, data sources, controls and procedures for recording, storing, managing, using, circulating and exchanging it, making it available, and the mechanisms for linking it with the Ministr…

1. The BOD shall issue a decision on the controls, conditions and good vigilance practices that shall be adhered to by the Marketing Rights holder, licensed Pharmaceutical Establishments and Biobanks. The EDE shall be co…

1. Without prejudice to the legislation in force in this regard and in cases that require ensuring the public health of individuals, the EDE is committed to educating health professionals, patients and members of society…

1. The EDE may suspend the circulation of the Medical Product if it is necessary to confirm information indicating its lack of quality, safety or effectiveness. The EDE shall issue a decision to withdraw the entire Medic…

1. The Ministry shall be responsible for licensing the practice of the pharmacy profession in Pharmaceutical Establishments and Biobanks that are subject to the EDE license. 2. The Ministry or the Competent Health Author…

1. The Ministry or the Competent Health Authority, each within the limits of their jurisdiction, shall consider and approve applications submitted to license or renew licenses of persons to practice the profession of pha…

A Pharmacist licensed to practice any activity in the field of the pharmacy profession shall perform his work in accordance with the principles and customs of practicing the profession, and shall preserve its honour and …

Subject to the provisions of Article (72) of this Decree-Law, the Clinical Pharmacist may provide his specialized services and practice clinical pharmacy, provided that the practice is in a health Establishment licensed …

A person licensed to practice the profession of pharmacy may not commit an act that violates the duties of the profession or violates the requirements of honesty or honour. He is specifically prohibited from the followin…

1. A licensed Pharmacist may not dispense Medical Products without a prescription, if the dispensing requires it. In all cases, the prescription shall be: a. Documented in clear handwriting or printed electronically and …

1. The Pharmacist may not dispense prescriptions that include Pharmaceutical Products containing narcotic substances or psychotropic substances in accordance with Federal Decree-Law No. (30) of 2021 referred to, unless t…

The Pharmacist may not change or alter anything contained in the medical prescription except after obtaining the written opinion of the person who issued it. An exception to this is the Pharmacist replacing a Pharmaceuti…

The Pharmacist may not repeat the dispensing of a medical prescription that contains controlled or semi-controlled substances that have the property of accumulating in the body, or that lead to habituation to their use o…

The Pharmacist is obligated to contact the treating physician if he suspects or finds that there is a fundamental error in the prescription to clarify and request correction if necessary.

The Pharmacist shall record the prescriptions for controlled and semi-controlled substances and products that have been dispensed on the Narcotic and Psychotropic Substances Tracking Platform in force in the State.

A Healthcare Practitioner licensed to issue a prescription may not issue a prescription for himself, his spouse, or his relatives up to the second degree for controlled substances and products.

1. No person may open a General Pharmacy unless he has obtained a license from the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. 2. The following conditions shall be met to obt…

1. The License to open a General Pharmacy shall be valid for a period of not less than one year, renewable. The License holder shall comply with practicing the licensed activity during the specified period of validity of…

1. Subject to the legislation in force in the State, no General Pharmacy may be transferred from one place to another, or any change made to its plan under which it was licensed, without the approval of the Ministry or t…

The General Pharmacy may not: 1. Practicing any activity not licensed. 2. Practicing the activity before obtaining the final license from the Ministry or the Competent Health Authority, each within the limits of their ju…

1. With the exception of General Pharmacies affiliated with Government Health Establishments, the Ministry or the Competent Health Authority, each within their jurisdiction, shall issue a decision to temporarily close th…

With the exception of General Pharmacies affiliated with Government Health Establishments, the Ministry or the Competent Health Authority, each within their jurisdiction, may issue a decision to cancel the license of the…

If the Pharmacist Responsible for the General Pharmacy is absent, the Owner shall entrust its responsibility to a licensed Pharmacist, after the approval of the Ministry or the Competent Health Authority, each within the…

1. It is permitted to license the opening of more than one General Pharmacy in accordance with the Pharmacy Chain System specified in the Executive Regulations of this Decree-Law. 2. The General Pharmacy and the Pharmacy…

1. Government Health Authorities and Establishments may open a pharmacy or pharmacies affiliated with them after obtaining a license to do so from the Ministry or the Competent Health Authority, each within the limits of…

1. No person may open a Compound Pharmacy unless he has obtained a license from the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. 2. The following conditions shall be met to ob…

1. The License to open a Compound Pharmacy shall be valid for a period of not less than one year, renewable. The License holder shall comply with practicing the licensed activity during the specified period of validity o…

1. Subject to the legislation in force in the State, no Compound Pharmacy may be transferred from one place to another, or any change made to its plan under which it was licensed, without the approval of the Ministry or …

The Compound Pharmacy is prohibited from the following: 1. Practicing any activity not licensed. 2. Dealing with other unlicensed Pharmaceutical Establishments. 3. The installation of Medical Products shall not commence …

1. The Ministry or the Competent Health Authority, each within their jurisdiction, shall issue a decision to temporarily suspend the License of the Compound Pharmacy for a period not exceeding one month, in any of the fo…

With the exception of General Pharmacies affiliated with Government Health Establishments, the Ministry or the Competent Health Authority, each within their jurisdiction, shall issue a decision to temporarily close the C…

1. No person may open a Medical Warehouse or Medical Store unless he has obtained a license from the EDE. 2. The following conditions shall be met to obtain a license to open a Medical Warehouse or store: a. Obtain a val…

1. The License to open Medical Warehouses and Medical Stores shall be valid for a period of not less than one year, renewable. The License holder shall comply with practicing the licensed activity during the specified pe…

1. Subject to the legislation in force in the State, no Medical Warehouses and Medical Stores may be transferred from one place to another, or any change made to its plan under which it was licensed, without the approval…