Medical Products, Pharmacy Profession and Pharmaceutical Establishments Law — articles 101–183

The Medical Warehouse or Medical Store may not: 1. Practicing any activity not licensed. 2. Delivering or selling Medical Products or raw materials to parties other than those licensed to trade in these products. 3. Impo…

1. The EDE shall issue a decision to temporarily suspend the License of the Medical Warehouse or Medical Store, in any of the following cases: a. Withdraw, cancel or non-renew Certificate of Good Practice for Warehousing…

The EDE shall issue a decision to cancel the License of the Medical Warehouse or Medical Store, in any of the following cases: 1. The Medical Warehouse or Medical Store is practicing an activity for which it is not licen…

1. The Pharmacist in charge or the person in charge of the Medical Warehouse or Medical Store shall maintain a general record or information system, in which the type and quantity of Medical Products received by the ware…

1. The Medical Warehouse shall place the selling price to the public on the outer packaging of the Medical Product subject to pricing and approved by the EDE in a clear and easy-to-read manner before selling and deliveri…

1. No person may open a Marketing Office unless he has obtained a license from the EDE. 2. The following conditions shall be met to obtain a license to open a Marketing Office: a. Providing evidence that the Applicant fo…

1. The License to open a Marketing Offices 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, the Marketing Office may not be moved from one place to another without the approval of the EDE. 2. Without prejudice to the legislation in force in the State, the Own…

The Marketing Office may not: 1. Practice any activity not licensed. 2. Importing or storing Medical Products for sale or distribution. 3. Dealing with other unlicensed Pharmaceutical Establishments. 4. Any other prohibi…

1. The Marketing Office may, through the licensed Medical Warehouse appointed by it, import the Medical Products necessary for it to perform its activity after obtaining approval from the EDE in accordance with the provi…

1. The EDE shall issue a decision to temporarily suspend the License of the Marketing Office, in any of the following cases: a. Transfer of Ownership of the Marketing Office to another person without the approval of the …

The EDE shall issue a decision to cancel the License of the Marketing Office, in any of the following cases: 1. The Marketing Office is carrying out an unlicensed activity. 2. If it is proven that obtaining the license t…

1. No person may open a Pharmaceutical Consulting Office unless he has obtained a license from the EDE. 2. The following conditions shall be met to obtain a license to open a Pharmaceutical Consulting Office: a. To entru…

1. The License to open a Pharmaceutical Consulting Office 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 perio…

1. Subject to the legislation in force in the State, the Pharmaceutical Consulting Office may not be moved from one place to another without the approval of the EDE. 2. Without prejudice to the legislation in force in th…

Pharmaceutical Consulting Office may not: 1. Practicing any activity not licensed. 2. Import, export, store, distribute or sell any Medical Products. 3. Providing advice or consultations to areas and establishments outsi…

1. The EDE shall issue a decision to temporarily suspend the License of the or Pharmaceutical Consulting Office, in any of the following cases: a. Transfer of Ownership of the Pharmaceutical Consulting Office to another …

The EDE may issue a decision to cancel the license of the Pharmaceutical Consulting Office, in any of the following cases: 1. The Pharmaceutical Consulting Office is practicing an unlicensed activity. 2. If it is proven …

1. No person may open a Pharmaceutical Laboratory unless he has obtained a license from the EDE. 2. The following conditions shall be met to obtain a license to open a Pharmaceutical Laboratory: a. Obtain a valid Good La…

1. The License to open a Pharmaceutical Laboratory 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 va…

1. The licensed Pharmaceutical Laboratory shall comply with the standards of good laboratory practice approved by the EDE. 2. The person responsible for the Pharmaceutical Laboratory shall approve the certificates of the…

1. Subject to the legislation in force in the State, it is not permitted to move the Pharmaceutical Laboratory from one place to another, or make any change in its plan in accordance with which its license was issued, wi…

The Pharmaceutical Laboratory may not: 1. Practicing any activity not licensed. 2. Importing or storing Medical Products for sale or advertisement or presenting 3. Conducting any research or testing on humans for any rea…

1. The EDE shall issue a decision to temporarily suspend the License of the Pharmaceutical Laboratory, in any of the following cases: a. Transfer of Ownership of the Pharmaceutical Laboratory to another person without th…

The EDE may issue a decision to cancel the License of the Pharmaceutical Laboratory, in any of the following cases: 1. The Pharmaceutical Laboratory is practicing an activity for which it is not licensed. 2. If it is pro…

1. No person may open a Medical Product Factories and Contracting Companies Manufacture Medical Products unless he has obtained a license from the EDE. 2. The following conditions shall be met to obtain a license to open…

The Medical Products Manufacturer and the contracted Medical Products manufacturing company shall comply with the quality management standards and good manufacturing practices controls issued and approved by the EDE.

1. The License to open a Medical Product Factories and Contracting Companies Manufacture Medical Products shall be valid for a period of not less than one year, renewable. The License holder shall comply with practicing …

1. Subject to the legislation in force in the State, no Medical Product Factories and Contracting Companies Manufacture Medical Products may be transferred from one place to another, or any change made to its plan under …

Medical Product Factories and Contracting Companies Manufacture Medical Products may not: 1. Practicing any activity not licensed. 2. Remanufacturing a Medical Product that has a valid Marketing Approval with new technic…

1. The EDE shall issue a decision to temporarily suspend the License of Medical Product Factories and Contracting Companies Manufacture Medical Products, in any of the following cases: a. Transfer of Ownership of the Fac…

The EDE shall issue a decision to temporarily cancel the License of Medical Product Factories and Contracting Companies Manufacture Medical Products, in any of the following cases: 1. The factory or contracting company i…

1. The Medical Product Factories and Contracting Companies Manufacture Medical Products shall place the selling price to the public on the outer packaging of the Medical Product subject to pricing and approved by the EDE…

1. No person may open a Licensing Contractual Company for Research and Development unless he has obtained a license from the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. 2. Th…

1. The License to open Contractual Company for Research and Development 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 s…

1. Subject to the legislation in force in the State, no Contractual Company for Research and Development may be transferred from one place to another, or any change made to its plan under which it was licensed, without t…

The Contractual Company for Research and Development may not: 1. Practicing any activity not licensed. 2. Circulation in counterfeit or unusable products. 3. Manufacture of products for non-Research and Development purpo…

1. The Ministry or the Competent Health Authority, each within their jurisdiction, shall issue a decision to temporarily suspend the License of Contractual Company for Research and Development for a period not exceeding …

The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision to cancel the License of the Contractual Company for Research and Development, in any of the following cases: 1. The Contr…

1. No person may open a Biobank 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 obtain a lic…

1. Blood storage units may not be established in government or private Health Establishments without obtaining a license from the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. …

1. The License to open a Biobank 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 the Lice…

1. Subject to the legislation in force in the State, no Biobank 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 Compet…

Biobank may not: 1. Practicing any activity not licensed. 2. Importing or exporting biological samples without obtaining the approval of the Competent Health Establishment or Authority, each within the limits of their ju…

1. The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision to temporarily suspend the License of the Biobank, in any of the following cases: a. Transferring Ownership of a Bioban…

1. The Competent Health Establishment or Authority, each within the limits of their jurisdiction, may issue a decision to cancel the Biobank license, in any of the following cases: a. The Biobank is carrying out an unlic…

1. No person may open Non-Clinical and Clinical Research Entity unless he has obtained a license from the EDE or the Competent Health Authority, each within the limits of their jurisdiction. 2. The following conditions s…

1. The License to open Clinical and Non-Clinical Research Entity 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 specifie…

1. Subject to the legislation in force in the State, Clinical and Non-Clinical Research Entity may be transferred from one place to another, or any change made to its plan under which it was licensed, without the approva…

Non-Clinical and Clinical Research Entities may not: 1. Practicing any activity not licensed. 2. Conducting any clinical or non-Clinical Research without obtaining the necessary approvals in accordance with the relevant …

1. The Ministry or the Competent Health Authority, each within their jurisdiction, shall issue a decision to temporarily suspend the License of the Non-Clinical and Clinical Research Entity for a period not exceeding one…

The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision to cancel the License of the Non-Clinical and Clinical Research Entity, in any of the following cases: 1. The Non-Clinical…

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

1. The License to open Bioequivalence Centre 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…

1. Subject to the legislation in force in the State, no Bioequivalence Centre 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…

Bioequivalence Centre may not: 1. Practicing any activity not licensed. 2. Conducting any clinical or non-Clinical Research without obtaining the necessary approvals in accordance with the relevant legislation. 3. Import…

1. The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision to temporarily suspend the License of the Bioequivalence Centre, in any of the following cases: a. Withdraw or cancel o…

The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision to cancel the license of the Bioequivalence Centre, in any of the following cases: 1. The Bioequivalence Centre is carryin…

1. The EDE, Ministry or Competent Health Authority, each within the limits of their jurisdiction, shall supervise the compliance of Pharmaceutical Establishments and Biobanks with the provisions of this Decree-Law, its E…

1. Without prejudice to the criminal penalties stipulated in this Decree-Law or any other laws, the EDE, Ministry or Competent Health Authority, each within the limits of their jurisdiction, may impose any of the followi…

A record shall be established in each of the EDE, the Ministry and the Competent Health Authority, in which the penalties imposed on License Holders shall be recorded. These authorities shall exchange data on violations …

1. Anyone against whom a disciplinary penalty decision has been issued in accordance with Article (160) of this Decree-Law may appeal the decision before the Appeals Committee referred to in Article (170) of this Decree-…

Disciplinary accountability in accordance with the provisions of this Decree-Law shall not prejudice criminal or civil liability, where applicable.

1. Any one who shall be punished by imprisonment for a period of not less than (6) six months and not exceeding (2) two years and a fine of not less than (50,000) fifty thousand AED and not more than (200,000) two hundre…

1. Any one who shall be punished by imprisonment for a period of not less than (6) six months and not exceeding one year and a fine of not less than (50,000) fifty thousand AED and not more than (200,000) two hundred tho…

A fine not exceeding two one hundred thousand AED (100,000) shall be imposed on any person who: 1. Violation of the approved pricing of Medical Products by the EDE, and the penalty will be doubled in the event of recurre…

Imprisonment and a fine not less than on two hundred thousand AED (200,000) and not exceeding two million AED (1,000,000) shall be imposed on any person who: 1. Fraud or counterfeiting a Medical Product, raw materials or…

1. In all cases, the court may, in addition to the prescribed penalties, rule to close the Pharmaceutical Establishment or Biobank for a period not exceeding (3) three months or to close it permanently with the withdrawa…

The Application of the penalties stated in this Decree shall not prejudice any more severe penalty provided by any other law.

Subject to Article (162) of this Decree-Law, anyone against whom a decision has been issued in implementation of the provisions of this Decree-Law may file a grievance before the Grievance Committee formed for this purpo…

The Ministry, the Competent Health Authority, the federal Health Authority, and the federal and local non-health government authority may appoint Pharmacists to practice the profession, provided that they obtain a licens…

By a decision of the Minister of Justice in agreement with the Chairman or the Minister, or by a decision of the head of the competent local judicial authority in agreement with the head of the competent health authority…

Obtaining the Licenses stipulated in this Decree-Law does not exempt from obtaining other licenses required by the laws, regulations or systems in force in the State.

The EDE, the Ministry and the Competent Health Authority shall establish a mechanism for mutual notification of licenses issued by them to Pharmaceutical Establishments and Biobanks and any information related thereto.

Those who are under the provisions of this Law at the time of its issuance shall regularize their status in accordance with its provisions within a period not exceeding one year from the date of enforcement. This period …

1. The Executive Regulations of this Decree-Law shall specify, in particular, the terms and conditions of the following: a. Providing the necessary Pharmaceutical Products and medical supplies to meet the community needs…

The Cabinet shall issue, based on the proposal of the Minister of Finance, the necessary decisions to determine the fees for services provided by the EDE, the Ministry, and the Ministry of Interior, in implementation of …

The Cabinet may issue a decision to delegate some of the powers of the Ministry or institution stipulated in this Decree-Law to any federal or local government EDE, based on the proposal of the minister or the president,…

The Cabinet may establish one or more committees based on the President proposal to enable the EDE to exercise its powers stipulated in this Decree-Law.

1. The aforementioned Federal Law No. (8) of 2019 is hereby repealed, as well as any provision that violates or contradicts the provisions of this Decree-Law. 2. The regulations and resolutions applying the aforementione…

This Decree-Law shall be published in the Official Gazette and shall enter into force as of January 02, 2025.

List No. (1) - Chemical name in English; chemical name in Arabic; IUPAC synonym; CAS number: 1. N-Phenethyl-4-piperidone (NPP); N-فينيتيل-4-بيبيريدون; 1-(2-phenylethyl)-piperidin-4-one; 39742-60-4. 2. 1-Phenyl-2-propanon…

List No. (2) - Chemical name in English; chemical name in Arabic; IUPAC synonym; CAS number: 1. Acetone; الأسيتون; 2-propanone; 67-64-1. 2. Anthranilic acid; حمض الأنترانيل; 2-aminobenzoic acid; 118-92-3. 3. Ethyl ether;…