Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments

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## Legislations
Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments
## Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments
Federal Decree-Law Governing Medical Products, Pharmacists and Pharmaceutical Establishments
The last update on this law was listed on 01 Oct 2024
Related legislations
Issued Date
## 01 Oct 2024
Effective Date
## 02 Jan 2025
Official Gazette Date
## 14 Oct 2024
Official Gazette No
## 785
Legislation State
## Active
Regulation Table
## 1
: Every effort has been made to produce an accurate and complete English version of this website/ le
Disclaimer
## Index
Index
## Part One: General Provisions
## Part Two: Regulation and Circulation of Medical Products
## Part Three: Controlled and Semi-Controlled Substances, Products and Chemical Precursors
## Part Four: National Databases
## Part Five: Pharmacovigilance
## Part Six: Regulating the Practice of Pharmacy
## Part Seven: Licence of Pharmaceutical Establishments and Biobanks
## Chapter One: General Pharmacies and Pharmacy Chains
## Chapter Two: Licence to Open a Compound Pharmacy
## Chapter Three: Medical Warehouses and Medical Stores Licence
## Chapter Four: Marketing Offices Licence
## Chapter Five: Licence Pharmaceutical Consulting Offices
## Chapter Six: Pharmaceutical Products
## Chapter Seven: Licensing Medical Product Factories and Contracting Companies Manufacture Medical Pro
## Chapter Eight: Licensing Contractual Companies for Research and Development
## Chapter Nine: Biobank Licensing
## Chapter Ten: Licensing Non-Clinical and Clinical Research Entities
## Chapter Eleven: Licensing of Bioequivalence Centres
## Part Eight: Administrative and Disciplinary Accountability and Criminal Sanctions
## Chapter One: Administrative and Disciplinary Questioning
## Part Nine: Final Provisions
## Federal Decree-Law No. (38) of 2024 Governing Medical Products, Pharmacists and Pharmaceutical Estab
− Upon reviewing the Constitution; − Federal Law No. (1) of 1972 Concerning the Competences of Minis
We, Mohammed Bin Zayed Al Nahyan, President of the United Arab Emirates;
Have promulgated the following Decree-Law:
## Part One: General Provisions
## Article (1) Definitions
In application of the provisions of this Decree-Law, the following words and phrases shall have the
State:
The Ministry:
The EDE:
Minister:
Board of Directors (BOD):
Chairman:
Competent Health Entity:
Medical Product:
Pharmaceutical Product:
Biopharmaceutical Products:
Advanced Medical Treatment Products:
Local Product:
Food Supplements:
Cosmetics:
Innovative Product:
Orphan Pharmaceutical Product:
Alternative Product:
Compassionate Use:
Medical Equipment:
Health Care Product:
Pharmaceutical Product:
Veterinary Product:
Personalized Medicine:
Defective Product:
Counterfeit Product:
Preliminary Materials:
Pharmaceutical Raw Materials:
Excipients and Solvents:
Active ingredient:
Marketing Approval:
Annex to the Marketing Approval:
Product Brochure:
The Main Effects of the Medical Product:
New Use:
Approved Pharmacopoeia:
Pharmaceutical Form:
New Way to Use:
Side View:
Reverse Reaction:
Opposite Event:
Adverse Reaction:
Serious Side Effect or Serious Adverse Event:
Non Clinical Research:
Clinical Research:
Bioavailability:
Bioequivalence:
Research Information:
Equivalent Alternative:
Stability Studies:
Batches:
Product Withdrawal:
Reference Manuals:
Practitioner:
Pharmacy Profession:
Clinical Pharmacy:
Qualified Person:
Pharmacist:
Pharmacist in Charge:
Precautionary Closure:
Clinical Pharmacist:
Medical Equipment Engineer:
Prescription:
Treatment Plan:
Medical Product Use (Protocol):
Patient Treatment Guide:
Direct Supervision and Control:
Establishment:
General Pharmacy:
Pharmacy Chain:
Compound Pharmacy:
Medical Warehouse:
Medical Store:
Marketing Office:
Pharmaceutical Consulting Office:
Medical Products Factory:
Pharmaceutical Laboratory:
Contractual Company for Research and Development:
Contract Manufacturing Company:
Biobank:
Biological Sample:
Bioequivalence Centre:
Storage:
Manufacturing:
Distribution:
Import:
Export:
Re-export:
Import or Export Permit:
Import or Export Approval:
Importer:
Distributor:
Marketing Rights Holder:
Lab Study:
Controlled Materials and Products:
Toxic Substances and Plants:
Prohibited Veterinary Substances:
Narcotics and Psychotropic Substances:
Semi-Controlled Products:
Hazardous Medical Products:
Chemical Precursors:
Exclusive Marketing:
Pharmacovigilance:
Grey Market:
## Article (2) Decree-Law Scope of Application
The provisions of this Decree-Law shall apply to the following products, professions, and establishm
## Part Two: Regulation and Circulation of Medical Products
## Article (3) Approved Pharmacopoeia
The EDE, in coordination with the Competent Health Authority, shall prepare, publish and update the
## Article (4) Exclusive Marketing Approval
1. The EDE may grant approval for the exclusive marketing of a Medical Product in accordance with th
## Article (5) Marketing Approval
1. Without prejudice to the applicable legislation concerning veterinary preparations, it is not ...
## Article (6) Terms and Conditions for Granting Marketing Approval
1. The Marketing Approval for the Medical Product is issued by the EDE in accordance with the follow
## Article (7) Marketing Approval Validity and Renewal Term
1. The Marketing Approval shall be valid for a period of (5) five years, and shall be renewed for si
## Article (8) Conditional Marketing Approval
Without prejudice to the applicable legislation concerning intellectual property, the EDE may issue
## Article (9) Terms and Controls of Conditional Marketing Approval
1. The Conditional Marketing Approval for the Medical Product is issued by the EDE in accordance wit
## Article (10) Conditional Marketing Approval Validity and Renewal Term
1. Conditional Marketing Approval shall be valid for one year and is renewable for similar periods i
## Article (11) Emergency Use Approval
Without prejudice to the applicable legislation on intellectual property and as an exception to the
## Article (12) Controls and Conditions of Emergency Use Approval
1. Approval for Emergency Use of a Medical Product shall be issued in accordance with the following
## Article (13) Term of Emergency Use Approval and Renewal
1. The approval for Emergency Use of the Medical Product shall be valid for the term of the State of
## Article (14) Fast Track Marketing Approval
1. The EDE establishes a fast track with simplified procedures in line with quality, safety, efficac
## Article (15) Resubmission of Marketing Approval and Conditional Marketing Approval
The Marketing Approval or conditional Marketing Approval issued by the EDE is considered invalid and
## Article (16) Approval of Minor Changes to the Medical Product
The Marketing Right Holder shall submit a request for minor changes to the Medical Product to the ED
## Article (17) Cancellation of All Types of Marketing Approval or Cancellation of Emergency Use Approv
1. The EDE may issue a decision to cancel the Marketing Approval, conditional Marketing Approval, or
## Article (18) Protect Intellectual Property
Without prejudice to the applicable legislation concerning intellectual property, documents and data
## Article (19) Scientific Fraud
Pharmaceutical Establishments licensed to manufacture, market or distribute the Medical Product or p
## Article (20) Product Pricing
The Marketing of a Medical Product that has obtained Marketing Approval requires the existence of a
## Article (21) Marketing Rights Holder Obligations
The Applicant for Marketing Rights or his representative for marketing Medical Products shall undert
## Article (22) Appointment of Pharmaceutical Establishments
1. The Marketing Right Holder shall appoint at least two Pharmaceutical Establishments licensed by t
## Article (23) Obligations of the Appointed by the Marketing Rights Holder
The qualified person appointed by the Marketing Right Holder shall undertake the following: 1. Provi
## Article (24) Civil Liability
The qualified person shall be responsible, together with the Marketing Right Holder, for any violati
## Article (25) Non-Clinical and Clinical Research
1. Non-Clinical Research on humans is prohibited, and the Executive Regulations of this Decree-Law s
## Article (26) Accredited or Licensed Laboratory
A laboratory study, product analysis certificate or quality certificate for a batch or batches of a
## Article (27) Medical Product Manufacturing Conditions
No Medical Product may be manufactured in the State for marketing therein, except after obtaining Ma
## Article (28) Good Practice
The BOD shall issue, by decision, rules, guidelines and standards of good practice that are consiste
## Article (29) Loan of Manufacturing Materials
1. Excipients and solvents may not be loaned or transferred between licensed factories in the State
## Article (30) Promoting Investment in the Medical Industries Sector
A system of incentives and benefits to attract investment and support innovation and development in
## Article (31) Approval or Permit to Import and Export Medical Product and Raw Materials
1. It is not permitted to import, export or re-export any Medical Product or any raw materials or ph
## Article (32) Conditions for Issuing Import or Export Approval or Permit
1. The approval or permit to import, export or re-export Medical Products, raw materials or pharmace
## Article (33) Cancellation of Approval or Permit Issued for Import or Export or Transfer of Ownership
1. The EDE shall issue a decision to cancel the approval or permit issued by it to import, export or
## Article (34) Operation Disclosure Certificate
1. A clearance certificate shall be obtained from the EDE for each batch of certain vital products t
## Article (35) Personal Use of the Medical Product
The Executive Regulations of this Decree-Law shall specify the conditions, rules and controls for br
## Article (36) Drug Policy Committee
Pursuant to this Decree-Law, a committee called the “Pharmaceutical Policy Committee” shall be estab
## Article (37) Providing Medical Product
1. None of the following categories may refuse to provide a Medical Product that has obtained Market
## Article (38) Medical Product Information
1. No Medical Product may be traded or marketed unless the information and data recorded on the inte
## Article (39) Prohibitions on Circulation and Selling
1. It is prohibited to trade in counterfeit, defective or expired Medical Products. 2. The sale of f
## Article (40) Prescription Medical Product Circulation
Non-Pharmaceutical Establishments are prohibited from importing, marketing, selling, displaying, sto
## Article (41) Circulation of Medical Product Without Prescription
The Executive Regulations of this Decree-Law shall specify the types of establishments other than ph
## Article (42) Description or Sale of a Medical Product
1. Physicians may not prescribe a Medical Product for new uses not specified in the internal leaflet
## Article (43) National Policy for Strategic Stock of Medical Products
The EDE shall issue the National Policy for the Strategic Stock of Medical Products after its approv
## Article (44) Medical Product Promotion and Advertising
1. It is prohibited to advertise, publicize or promote Medical Products by any means, whether visual
## Article (45) Conditions for Issuing Approval to Advertise a Medical Product
The approval for advertising, publicity or promotion of Medical Products shall be issued by the EDE
## Article (46) Validity Term of Approval for Advertising a Medical Product
The approval to advertise the Medical Product issued by the EDE shall be valid for a period ranging
## Article (47) Cancellation of Approval to Advertise or Transfer Ownership of a Medical Product
1. The EDE shall issue a decision to cancel the approval issued by it to advertise the Medical Produ
## Article (48) Approval for Safe Disposal of Medical Products
It is prohibited to destroy or safely dispose of Medical Products, except after obtaining approval f
## Article (49) Conditions for Issuing Approval of Safe Disposal from a Medical Product
1. Approval for the destruction or safe disposal of Medical Products shall be issued by the Competen
## Article (50) Conditions for Approval Validity Term for Safe Disposal of a Medical Product
1. The approval for the safe destruction and disposal of the Medical Product shall be valid for the
## Article (51) Cancellation of Approval of Safe Disposal of a Medical Product or Transfer of Ownership
1. The Competent Health Establishment or Authority, each within the limits of their jurisdiction, sh
## Part Three: Controlled and Semi-Controlled Substances, Products and Chemical Precursors
## Article (52) Prohibited Substances and Controlled Products and the Necessary Instructions Concerning
Subject to the provisions of any other legislation: 1. It is not permitted to install any Medical Pr
## Article (53) Preservation and Circulation of Controlled Materials and Products
The controls related to the storage and circulation of controlled materials and products shall be de
## Article (54) Controlled Materials and Products
Subject to the provisions of Article (55) of this Decree-Law, it is prohibited to possess controlled
## Article (55) Cases for Controlled Materials and Products
The Pharmacist Responsible for controlled substances and products in the pharmacy may not dispense c
## Article (56) Circulation of Controlled Materials and Products
The circulation of controlled materials and products between licensed Pharmaceutical or Health Estab
## Article (57) Import Procedures of Controlled Materials and Products
1. Pharmaceutical Establishments may not import controlled materials and products or their raw mater
## Article (58) Periodic Inventory of Controlled Materials and Products
The person responsible for the custody of controlled materials and products in any of the categories
## Article (59) Hazardous or Toxic Medical Products and Materials
1. Without prejudice to the provisions of international agreements to which the State is a party, ha
## Article (60) The Establishment has Suspended Working
If the Establishment that has been issued a permit to possess controlled materials and products stop
## Article (61) Semi-Controlled Materials and Products
The list of semi-controlled medical materials and products and the terms and conditions for their ci
## Article (62) Lists of Chemical Precursors
1. Without prejudice to international agreements to which the State is a party or any other law, two
## Article (63) Prohibitions on Precursor Chemicals Used for Medical Purposes
1. It is prohibited to bring, import, export, manufacture, extract, separate, produce, possess, dist
## Article (64) Prohibitions on Precursor Chemicals Used for Medical Purposes
1. It is prohibited to bring, import, export, manufacture, extract, separate, produce, possess, dist
## Part Four: National Databases
## Article (65) National System for Tracking and Coding of Medical Products
1. The EDE, in coordination with the Competent Health Authority, shall establish a National System f
## Article (66) Medical Products Database and Pricing
1. A national database for Medical Products shall be established in the EDE, in which all data and i
## Article (67) Database of Pharmaceutical Establishments, Biobanks and Other Databases
The mechanism of the system operation, data sources, controls and procedures for recording, storing,
## Part Five: Pharmacovigilance
## Article (68) Reporting and Interested Parties
1. The BOD shall issue a decision on the controls, conditions and good vigilance practices that shal
## Article (69) Awareness and Education on Safety Information Related to Medical Products
1. Without prejudice to the legislation in force in this regard and in cases that require ensuring t
## Article (70) Suspension and Withdrawal of Medical Product
1. The EDE may suspend the circulation of the Medical Product if it is necessary to confirm informat
## Part Six: Regulating the Practice of Pharmacy
## Article (71) Terms and Conditions for Practising the Profession of Pharmacy and Registration Records
1. The Ministry shall be responsible for licensing the practice of the pharmacy profession in Pharma
## Article (72) License Applications and License Renewals
1. The Ministry or the Competent Health Authority, each within the limits of their jurisdiction, sha
## Article (73) Duties
A Pharmacist licensed to practice any activity in the field of the pharmacy profession shall perform
## Article (74) Clinical Pharmacy
Subject to the provisions of Article (72) of this Decree-Law, the Clinical Pharmacist may provide hi
## Article (75) Prohibitions
A person licensed to practice the profession of pharmacy may not commit an act that violates the dut
## Article (76) Prescription
1. A licensed Pharmacist may not dispense Medical Products without a prescription, if the dispensing
## Article (77) Narcotics and Psychotropic Substances
1. The Pharmacist may not dispense prescriptions that include Pharmaceutical Products containing nar
## Article (78) Change or Alter What Is Stated in the Prescription
The Pharmacist may not change or alter anything contained in the medical prescription except after o
## Article (79) Duplicate Prescription Dispensing
The Pharmacist may not repeat the dispensing of a medical prescription that contains controlled or s
## Article (80) Prescription Mistake
The Pharmacist is obligated to contact the treating physician if he suspects or finds that there is
## Article (81) Prescription Registration
The Pharmacist shall record the prescriptions for controlled and semi-controlled substances and prod
## Article (82) Prohibition of Prescription for Self or a Relative
A Healthcare Practitioner licensed to issue a prescription may not issue a prescription for himself,
## Part Seven: Licence of Pharmaceutical Establishments and Biobanks
## Chapter One: General Pharmacies and Pharmacy Chains
## Article (83) License Conditions
1. No person may open a General Pharmacy unless he has obtained a license from the Ministry or the C
## Article (84) License Term and Renewal
1. The License to open a General Pharmacy shall be valid for a period of not less than one year, ren
## Article (85) Transfer or Assignment of Ownership of a General Pharmacy
1. Subject to the legislation in force in the State, no General Pharmacy may be transferred from one
## Article (86) Prohibitions
The General Pharmacy may not: 1. Practicing any activity not licensed. 2. Practicing the activity be
## Article (87) Temporary Closure of the General Pharmacy
1. With the exception of General Pharmacies affiliated with Government Health Establishments, the Mi
## Article (88) General Pharmacy License Cancellation
With the exception of General Pharmacies affiliated with Government Health Establishments, the Minis
## Article (89) Absence of Pharmacist in Charge
If the Pharmacist Responsible for the General Pharmacy is absent, the Owner shall entrust its respon
## Article (90) General and E-Pharmacies Chain
1. It is permitted to license the opening of more than one General Pharmacy in accordance with the P
## Article (91) Affiliated Pharmacies
1. Government Health Authorities and Establishments may open a pharmacy or pharmacies affiliated wit
## Chapter Two: Licence to Open a Compound Pharmacy
## Article (92) License Conditions
1. No person may open a Compound Pharmacy unless he has obtained a license from the Ministry or the
## Article (93) License Term and Renewal
1. The License to open a Compound Pharmacy shall be valid for a period of not less than one year, re
## Article (94) Transfer or Assignment of Ownership of a Compound Pharmacy
1. Subject to the legislation in force in the State, no Compound Pharmacy may be transferred from on
## Article (95) Prohibitions
The Compound Pharmacy is prohibited from the following: 1. Practicing any activity not licensed. 2.
## Article (96) License Suspension and Precautionary Closure
1. The Ministry or the Competent Health Authority, each within their jurisdiction, shall issue a dec
## Article (97) Compound Pharmacy License Cancellation
With the exception of General Pharmacies affiliated with Government Health Establishments, the Minis
## Chapter Three: Medical Warehouses and Medical Stores Licence
## Article (98) License Conditions
1. No person may open a Medical Warehouse or Medical Store unless he has obtained a license from the
## Article (99) License Term and Renewal
1. The License to open Medical Warehouses and Medical Stores shall be valid for a period of not less
## Article (100) Transfer or Assignment of Ownership of a Medical Warehouse or Medical Store
1. Subject to the legislation in force in the State, no Medical Warehouses and Medical Stores may be
## Article (101) Prohibitions
The Medical Warehouse or Medical Store may not: 1. Practicing any activity not licensed. 2. Deliveri
## Article (102) License Suspension and Precautionary Closure
1. The EDE shall issue a decision to temporarily suspend the License of the Medical Warehouse or Med
## Article (103) License Cancellation
The EDE shall issue a decision to cancel the License of the Medical Warehouse or Medical Store, in a
## Article (104) Maintain a Public Record or Information System
1. The Pharmacist in charge or the person in charge of the Medical Warehouse or Medical Store shall
## Article (105) Setting the Price of the Medical Product
1. The Medical Warehouse shall place the selling price to the public on the outer packaging of the M
## Chapter Four: Marketing Offices Licence
## Article (106) License Conditions
1. No person may open a Marketing Office unless he has obtained a license from the EDE. 2. The follo
## Article (107) License Term and Renewal
1. The License to open a Marketing Offices shall be valid for a period of not less than one year, re
## Article (108) Transfer or Assignment of Marketing Office
1. Subject to the legislation in force in the State, the Marketing Office may not be moved from one
## Article (109) Prohibitions
The Marketing Office may not: 1. Practice any activity not licensed. 2. Importing or storing Medical
## Article (110) Introductory Materials, Products and Free Samples
1. The Marketing Office may, through the licensed Medical Warehouse appointed by it, import the Medi
## Article (111) License Suspension and Precautionary Closure
1. The EDE shall issue a decision to temporarily suspend the License of the Marketing Office, in any
## Article (112) License Cancellation
The EDE shall issue a decision to cancel the License of the Marketing Office, in any of the followin
## Chapter Five: Licence Pharmaceutical Consulting Offices
## Article (113) License Conditions
1. No person may open a Pharmaceutical Consulting Office unless he has obtained a license from the E
## Article (114) License Term and Renewal
1. The License to open a Pharmaceutical Consulting Office shall be valid for a period of not less th
## Article (115) Transfer or Assignment of Ownership of the Pharmaceutical Consulting Office
1. Subject to the legislation in force in the State, the Pharmaceutical Consulting Office may not be
## Article (116) Prohibitions
Pharmaceutical Consulting Office may not: 1. Practicing any activity not licensed. 2. Import, export
## Article (117) License Suspension and Precautionary Closure
1. The EDE shall issue a decision to temporarily suspend the License of the or Pharmaceutical Consul
## Article (118) License Cancellation
The EDE may issue a decision to cancel the license of the Pharmaceutical Consulting Office, in any o
## Chapter Six: Pharmaceutical Products
## Article (119) License Conditions
1. No person may open a Pharmaceutical Laboratory unless he has obtained a license from the EDE. 2.
## Article (120) License Term and Renewal
1. The License to open a Pharmaceutical Laboratory shall be valid for a period of not less than one
## Article (121) Pharmaceutical Laboratory Obligations
1. The licensed Pharmaceutical Laboratory shall comply with the standards of good laboratory practic
## Article (122) Transfer or Assignment of Ownership of the Pharmaceutical Laboratory
1. Subject to the legislation in force in the State, it is not permitted to move the Pharmaceutical
## Article (123) Prohibitions
The Pharmaceutical Laboratory may not: 1. Practicing any activity not licensed. 2. Importing or stor
## Article (124) License Suspension and Precautionary Closure
1. The EDE shall issue a decision to temporarily suspend the License of the Pharmaceutical Laborator
## Article (125) License Cancellation
The EDE may issue a decision to cancel the License of the Pharmaceutical Laboratory, in any of the f
## Chapter Seven: Licensing Medical Product Factories and Contracting Companies Manufacture Medical Pro
## Article (126) License Conditions
1. No person may open a Medical Product Factories and Contracting Companies Manufacture Medical Prod
## Article (127) Quality Management Standards and Good Manufacturing Practices
The Medical Products Manufacturer and the contracted Medical Products manufacturing company shall co
## Article (128) License Term and Renewal
1. The License to open a Medical Product Factories and Contracting Companies Manufacture Medical Pro
## Article (129) Transfer of the Medical Product Factories and Contracting Companies Manufacture Medica
1. Subject to the legislation in force in the State, no Medical Product Factories and Contracting Co
## Article (130) Prohibitions
Medical Product Factories and Contracting Companies Manufacture Medical Products may not: 1. Practic
## Article (131) License Suspension and Precautionary Closure
1. The EDE shall issue a decision to temporarily suspend the License of Medical Product Factories an
## Article (132) License Cancellation
The EDE shall issue a decision to temporarily cancel the License of Medical Product Factories and Co
## Article (133) Setting the Price of the Medical Product
1. The Medical Product Factories and Contracting Companies Manufacture Medical Products shall place
## Chapter Eight: Licensing Contractual Companies for Research and Development
## Article (134) License Conditions
1. No person may open a Licensing Contractual Company for Research and Development unless he has obt
## Article (135) License Term and Renewal
1. The License to open Contractual Company for Research and Development shall be valid for a period
## Article (136) Transfer or Assignment of Ownership of the Contractual Company for Research and Develo
1. Subject to the legislation in force in the State, no Contractual Company for Research and Develop
## Article (137) Prohibitions
The Contractual Company for Research and Development may not: 1. Practicing any activity not license
## Article (138) License Suspension and Precautionary Closure
1. The Ministry or the Competent Health Authority, each within their jurisdiction, shall issue a dec
## Article (139) License Cancellation
The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision to
## Chapter Nine: Biobank Licensing
## Article (140) License Conditions
1. No person may open a Biobank unless he has obtained a license from the Ministry or the Competent
## Article (141) Licensing of Blood Storage Units in Government and Private Health Establishments
1. Blood storage units may not be established in government or private Health Establishments without
## Article (142) License Term and Renewal
1. The License to open a Biobank shall be valid for a period of not less than one year, renewable. T
## Article (143) Transfer or Assignment of Biobank
1. Subject to the legislation in force in the State, no Biobank may be transferred from one place to
## Article (144) Prohibitions
Biobank may not: 1. Practicing any activity not licensed. 2. Importing or exporting biological samp.
## Article (145) License Suspension and Precautionary Closure
1. The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision
## Article (146) License Cancellation
1. The Competent Health Establishment or Authority, each within the limits of their jurisdiction, ma
## Chapter Ten: Licensing Non-Clinical and Clinical Research Entities
## Article (147) License Conditions
1. No person may open Non-Clinical and Clinical Research Entity unless he has obtained a license fro
## Article (148) License Term and Renewal
1. The License to open Clinical and Non-Clinical Research Entity shall be valid for a period of not
## Article (149) Transfer or Assignment of Ownership of Non-Clinical and Clinical Research
1. Subject to the legislation in force in the State, Clinical and Non-Clinical Research Entity may b
## Article (150) Prohibitions
Non-Clinical and Clinical Research Entities may not: 1. Practicing any activity not licensed. 2. Con
## Article (151) License Suspension and Precautionary Closure
1. The Ministry or the Competent Health Authority, each within their jurisdiction, shall issue a dec
## Article (152) License Cancellation
The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision to
## Chapter Eleven: Licensing of Bioequivalence Centres
## Article (153) License Conditions
1. No person may open Bioequivalence Centre unless he has obtained a license from the EDE or the Com
## Article (154) License Term and Renewal
1. The License to open Bioequivalence Centre shall be valid for a period of not less than one year,
## Article (155) Transfer or Transfer of Bioequivalence Centre
1. Subject to the legislation in force in the State, no Bioequivalence Centre may be transferred fro
## Article (156) Prohibitions
Bioequivalence Centre may not: 1. Practicing any activity not licensed. 2. Conducting any clinical o
## Article (157) License Suspension and Precautionary Closure
1. The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision
## Article (158) License Cancellation
The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision to
## Article (159) Control and Inspection
1. The EDE, Ministry or Competent Health Authority, each within the limits of their jurisdiction, sh
## Part Eight: Administrative and Disciplinary Accountability and Criminal Sanctions
## Chapter One: Administrative and Disciplinary Questioning
## Article (160) Disciplinary Sanctions
1. Without prejudice to the criminal penalties stipulated in this Decree-Law or any other laws, the
## Article (161) Penalty Record
A record shall be established in each of the EDE, the Ministry and the Competent Health Authority, i
## Article (162) Appeal Against Disciplinary Penalty
1. Anyone against whom a disciplinary penalty decision has been issued in accordance with Article (1
## Article (163) Non-Prejudice to Criminal and Civil Liability
Disciplinary accountability in accordance with the provisions of this Decree-Law shall not prejudice
## Criminal Penalties: Article (164)
1. Any one who shall be punished by imprisonment for a period of not less than (6) six months and no
## Article (165)
1. Any one who shall be punished by imprisonment for a period of not less than (6) six months and no
## Article (166)
A fine not exceeding two one hundred thousand AED (100,000) shall be imposed on any person who: 1. V
## Article (167)
Imprisonment and a fine not less than on two hundred thousand AED (200,000) and not exceeding two mi
## Article (168) Additional Penalties
1. In all cases, the court may, in addition to the prescribed penalties, rule to close the Pharmaceu
## Article (169) Non-Prejudice to a More Severe Penalty
The Application of the penalties stated in this Decree shall not prejudice any more severe penalty p
## Part Nine: Final Provisions
## Article (170) Appeal Against Decisions Issued in Implementation of the Provisions of this Decree-Law
Subject to Article (162) of this Decree-Law, anyone against whom a decision has been issued in imple
## Article (171) Practising the Profession of Pharmacy in Government Agencies
The Ministry, the Competent Health Authority, the federal Health Authority, and the federal and loca
## Article (172) Judicial Police Officers
By a decision of the Minister of Justice in agreement with the Chairman or the Minister, or by a dec
## Article (173) Obtaining the Required Licenses
Obtaining the Licenses stipulated in this Decree-Law does not exempt from obtaining other licenses r
## Article (174) Mutual Notice
The EDE, the Ministry and the Competent Health Authority shall establish a mechanism for mutual noti
## Article (175) Regularization
Those who are under the provisions of this Law at the time of its issuance shall regularize their st
## Article (176) Executive Resolutions
1. The Executive Regulations of this Decree-Law shall specify, in particular, the terms and conditio
## Article (177) Fees and Fines
The Cabinet shall issue, based on the proposal of the Minister of Finance, the necessary decisions t
## Article (178) Authorization
The Cabinet may issue a decision to delegate some of the powers of the Ministry or institution stipu
## Article (179) Committees
The Cabinet may establish one or more committees based on the President proposal to enable the EDE t
## Article (180) Repeals
1. The aforementioned Federal Law No. (8) of 2019 is hereby repealed, as well as any provision that
## Article (181) Publication and Entry into Force of Decree-Law
This Decree-Law shall be published in the Official Gazette and shall enter into force as of January