Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments

Article-level navigation isn't available for this document — showing the full text as extracted.

Federal Decree by Law No. (21) of 2025 Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments

The last update on this law was listed on 01 Oct 2025
Issued Date: 01 Oct 2025
Effective Date: 01 Jan 2026
Official Gazette Date: 14 Oct 2025
Official Gazette No: 809 (ملحق 1)
Legislation State: Active

Preamble (preview): "We, Mohamed bin Zayed Al Nahyan, President of the United Arab Emirates, − Having reviewed the Constitution, − Federal Law No. (1) of 1972 Regarding the Competences of Minis[tries]... Hereby promulgate the following Decree by Law:"

Articles (index with preview text):

Article (1) Definitions — preview: For the purposes of implementing the provisions of this Decree by Law, the following terms and expre[ssions]... [defines] State / Ministry / Establishment / Minister / Board of Directors / Chairman / Competent Authority / Veterinary Medical Product / Veterinary Medicinal Product / Veterinary Biological Products / Active Substance / Veterinary Raw Materials / Veterinary Complementary Products / Veterinary Nutritional Supplements / Living Organisms / Injectable Veterinary Supplements / Animal Health Care Products / Veterinary Disinfectants / Veterinary Medical Device / Marketing Authorization / Veterinary Consignment / Veterinary Establishments / Veterinary Pharmaceutical Establishments / Veterinary Medical Warehouse / Veterinary Medical Storage Facility / Marketing Office / Veterinary Medical Products Contract Manufacturing Organization (CMO) / Contract Research and Development Organization (CRDO) / Veterinary Biobank / Veterinary Pharmacy / Bioequivalence Center / Marketing Authorization Holder / Veterinary Pharmacovigilance / Innovator Product / Orphan Product / Generic Product / Veterinary Non-Clinical Research / Veterinary Clinical Research / Target Animals / Bioequivalence / Bioavailability / Qualified Person / Solvents, Preservatives, and Excipients / Import, Export, or Re-export Approval / Import, Export, or Re-export Permit / Controlled Substances and Products / Narcotic Drugs and Psychotropic Substances / Semi-Controlled Substances and Products / Chemical Precursors / Prohibited Veterinary Substances / Restricted Substances / Side Effects / Adverse Reaction / Adverse Event / Unexpected Adverse Reaction / Genetically Modified Organism (GMO) / GMO Products for Veterinary Medical Use / Approved Pharmacopoeias / Non-Clinical Research Entities / Veterinary Clinical Research Entities / Certificate of Free Sale / Certificate of a Pharmaceutical Product (CPP) / Reference Authorities / Emergency Use Authorization / Grey Market / Batch.

Article (2) Scope of Application of the Decree by Law — preview: The provisions of this Decree by Law shall apply to the following Veterinary Medical Products and ve[terinary establishments]...

Article (3) Approved Pharmacopoeias — preview: The provisions stipulated in Federal Decree by Law No. (38) of 2024 Regarding Medical Products, the...

Article (4) Classification of Veterinary Medical Products — preview: The Establishment shall classify the Veterinary Medical Products intended to be imported, manufactur[ed]...

Article (5) List of Veterinary Vaccines — preview: A list of veterinary vaccines shall be prepared by agreement between the Ministry and the Establishm[ent]...

Article (6) Exclusive Marketing Authorization — preview: 1. The Establishment may grant exclusive marketing authorization for a Veterinary Medical Product to...

Article (7) Marketing Authorization — preview: 1. Without prejudice to the applicable legislation, it is prohibited to import, export, distribute,...

Article (8) Conditions and Controls for Granting Marketing Authorization — preview: 1. The marketing authorization for a Veterinary Medical Product shall be issued by the Establishment...

Article (9) Validity Period of Marketing Authorization and Renewal — preview: 1. The marketing authorization shall be valid for (5) five years and may be renewed for similar peri[ods]...

Article (10) Conditional Marketing Authorization — preview: 1. Without prejudice to the legislation in force regarding intellectual property, the Establishment...

Article (11) Conditions and Controls for Granting Conditional Marketing Authorization — preview: 1. The conditional marketing authorization for a Veterinary Medical Product shall be issued by the E[stablishment]...

Article (12) Validity Period of Conditional Marketing Authorization and Renewal — preview: 1. The conditional marketing authorization shall be valid for a period of one year and may be renewe[d]...

Article (13) Emergency Use Authorization — preview: Without prejudice to the legislation in force regarding intellectual property and as an exception to...

Article (14) Conditions and Controls for Emergency Use Authorization — preview: 1. The emergency use authorization for the Veterinary Medical Product is issued in accordance with t[he]...

Article (15) Validity and Extension of Emergency Use Authorization — preview: 1. The emergency use authorization for the Veterinary Medical Product shall be valid for the duratio[n]...

Article (16) Fast-Track Marketing Authorization — preview: 1. The Establishment shall establish a fast track with simplified procedures that are aligned with q[uality standards]...

Article (17) Resubmission of Application for Marketing Authorization and Conditional Marketing Authorization — preview: The marketing authorization or conditional marketing authorization issued by the Establishment shall...

Article (18) Approval of Minor Changes to the Veterinary Medical Product — preview: The marketing authorization holder shall submit an application to the Establishment to apply minor c[hanges]...

Article (19) Revocation of Marketing Authorization of All Types, or Revocation of Emergency Use Authorization — preview: 1. The Establishment may issue a decision to revoke the marketing authorization of any of its types...

Article (20) Intellectual Property Protection — preview: Without prejudice to the legislation in force regarding intellectual property, the documents and dat[a]...

Article (21) Scientific Fraud — preview: Veterinary Pharmaceutical Establishments licensed to manufacture, market, or distribute a Veterinary...

Article (22) Pricing of the Veterinary Medical Product — preview: For a Veterinary Medical Product to be circulated in the State, it is required to affix the specifie[d price]...

Article (23) Obligations of the Marketing Authorization Holder — preview: The marketing authorization holder or their representative for the purpose of marketing Veterinary M[edical Products]...

Article (24) Appointment of a Veterinary Pharmaceutical Establishment — preview: 1. The marketing authorization holder shall appoint one or more Veterinary Pharmaceutical Establishm[ents]...

Article (25) Obligations of the Appointee by the Marketing Authorization Holder — preview: The qualified person appointed by the marketing authorization holder is obligated to the following:...

Article (26) Liability of the Qualified Person and the Marketing Authorization Holder — preview: The qualified person shall be jointly liable with the marketing authorization holder, for any violat[ion]...

Article (27) Non-Clinical and Clinical Research on Veterinary Medical Products — preview: 1. It is prohibited to conduct non-clinical research on the target animal. The Executive Regulations...

Article (28) Approved or Licensed Laboratory — preview: A laboratory study, a certificate of analysis of a Veterinary Medical Product, or a quality certific[ate]...

Article (29) Conditions for Manufacturing a Veterinary Medical Product — preview: 1. No Veterinary Medical Product intended for marketing in the State may be manufactured unless a ma[nufacturing license is obtained]...

Article (30) Good Practice — preview: The Board of Directors shall issue a decision specifying the rules, guidelines, and standards of goo[d practice]...

Article (31) Transfer and Lending of Manufacturing Materials — preview: 1. Without prejudice to the approvals that may be required from the Competent Authority, it is not p[ermitted]...

Article (32) Enhancing Investment in the Veterinary Medical Industries Sector — preview: The Cabinet shall issue a resolution, based on the proposal of the Chairman and after coordination w[ith]...

Article (33) Approval or Permit for Import, Export, or Re-export of a Veterinary Consignment — preview: 1. It is not permitted to import, export, or re-export any Veterinary Consignment except after the i[ssuance of an approval or permit]...

Article (34) Conditions for Issuing an Import, Export, or Re-export Approval or Permit — preview: 1. An approval or permit to import, export, or re-export any Veterinary Consignment shall be issued...

Article (35) Revocation of Import, Export, or Re-export Approval or Permit and Transfer of its Ownership — preview: 1. The Establishment shall issue a decision revoking the approval or permit it has issued for the im[port]...

Article (36) Personal Use of Veterinary Medical Products — preview: 1. It is not permitted to bring, possess, or carry a Veterinary Medical Product by any person upon e[ntry]...

Article (37) Provision of Veterinary Medical Products — preview: 1. None of the following categories may refrain from providing a Veterinary Medical Product that has...

Article (38) Veterinary Medical Product Information — preview: 1. No Veterinary Medical Product may be circulated or marketed unless the information and data recor[ded]...

Article (39) Circulation of Veterinary Medical Products Requiring a Prescription — preview: Non-veterinary Pharmaceutical Establishments are prohibited from importing, marketing, selling, disp[ensing]...

Article (40) Circulation of Veterinary Medical Products Without a Prescription — preview: The Board of Directors shall issue a decision specifying the types of non-Veterinary Pharmaceutical...

Article (41) Prescribing and Selling Veterinary Medical Products — preview: 1. The prescription and sale of Veterinary Medical Products shall be subject to the following contro[ls]...

Article (42) Prohibition of Circulation and Sale — preview: 1. The circulation of adulterated, defective, expired, grey market Veterinary Medical Product, or pr[ohibited]...

Article (43) National Policy for the Strategic Stockpile of Veterinary Medical Products — preview: The Establishment shall issue the National Policy for the Strategic Stockpile of Veterinary Medical...

Article (44) Promotion of and Advertising for the Veterinary Medical Product — preview: 1. It is prohibited to advertise, publicize, or promote Veterinary Medical Products by any means, wh[ere]...

Article (45) Conditions for Issuing Approval for Advertising a Veterinary Medical Product — preview: Approval for advertising, publicizing, or promoting Veterinary Medical Products shall be issued by t[he Establishment]...

Article (46) Validity Period of the Approval for Advertising a Veterinary Medical Product — preview: The approval for advertising, publicizing, or promoting the Veterinary Medical Product issued by the...

Article (47) Revocation of the Approval for Advertising a Veterinary Medical Product and Transfer of its Ownership — preview: 1. The Establishment may issue a decision to revoke its approval for advertising, publicizing, or pr[omoting]...

Article (48) Safe Disposal of Veterinary Medical Products — preview: 1. The safe disposal of Veterinary Medical Products shall be carried out through a specialized compa[ny]...

Article (49) Controlled and Semi-Controlled Substances and Products, and Veterinary Chemical Precursors — preview: The same provisions set forth in Federal Decree by Law No. (30) of 2021 Regarding the Control of Nar[cotic Drugs]...

Article (50) Circulation of Prohibited and Restricted Substances — preview: 1. The circulation of Prohibited and Restricted Substances shall be subject to the following control[s]...

Article (51) National System for Tracking and Tracing Veterinary Medical Products — preview: 1. The tracking and tracing of Veterinary Medical Products from the manufacturer to the end-user sha[ll]...

Article (52) Database of Veterinary Medical Products — preview: All data and information related to Veterinary Medical Products, their technical specifications, and...

Article (53) Database of Veterinary Pharmaceutical Establishments — preview: All data and information related to Veterinary Pharmaceutical Establishments shall be kept in the Ph[armaceutical database]...

Article (54) Veterinary Pharmacovigilance — preview: 1. The Board of Directors shall issue a decision specifying the controls, conditions, and practices...

Article (55) Prohibition of Import, Suspension of Distribution, Ban on Circulation, or the Suspension of Marketing — preview: 1. The Board of Directors shall issue a decision specifying the controls, conditions, and practices...

Article (56) Certificate of Free Sale and Certificate of a Pharmaceutical Product for Veterinary Medical Products — preview: The Establishment shall issue a Certificate of Free Sale or a Certificate of a Pharmaceutical Produc[t]...

Article (57) Licensing of a Veterinary Pharmacy — preview: 1. No person may open a Veterinary Pharmacy unless they have obtained a license from the Ministry an[d]...

Article (58) Licensing of Veterinary Medical Warehouses Storage Facilities — preview: 1. No person may open a Veterinary Medical Warehouse or Storage Facility unless they have obtained a[license]...

Article (59) Licensing of Veterinary Medical Products Manufacturing Facilities and Contract Manufacturing Organizations — preview: 1. No person may open a Veterinary Medical Products Manufacturing Facility or Contract Manufacturing...

Article (60) Licensing of Marketing Offices — preview: 1. No person may open a Marketing Office unless they have obtained a license to do so from the Estab[lishment]...

Article (61) Licensing of Veterinary Biobanks — preview: 1. No person may open a Veterinary Biobank unless they have obtained a license from the Establishmen[t]...

Article (62) Pharmaceutical Consultancy Office — preview: A pharmaceutical consultancy office licensed in accordance with the provisions of Federal Decree by...

Article (63) Pharmaceutical Laboratories — preview: A Pharmaceutical Laboratory licensed in accordance with the provisions of Federal Decree by Law No....

Article (64) Licensing of Contract Research and Development Organizations — preview: 1. No person may open a Contract Research and Development Organization (CRDO) unless they have obtai[ned]...

Article (65) Licensing of Veterinary Non-Clinical and Clinical Research Entities — preview: 1. No person may open a Veterinary Non-Clinical or Clinical Research Entity unless they have obtaine[d]...

Article (66) Licensing of Bioequivalence Centers — preview: 1. No person may open a Bioequivalence Center unless they have obtained a license from the Establish[ment]...

Article (67) Validity and Renewal of Veterinary Pharmaceutical Establishment Licenses — preview: 1. A license to open a Veterinary Pharmaceutical Establishment shall be valid for a period of not le[ss than]...

Article (68) Prohibitions — preview: 1. Veterinary Pharmaceutical Establishments are prohibited from the following: a. Engaging in an[y]...

Article (69) Transfer of Veterinary Pharmaceutical Establishments or Assignment of Ownership — preview: 1. Subject to the legislation in force in the State, a Veterinary Pharmaceutical Establishment may n[ot]...

Article (70) Precautionary Closure — preview: 1. The Establishment or the Ministry, each within its competence, shall issue an immediate decision...

Article (71) Supervision and Inspection — preview: 1. The Establishment or the Ministry, each within its competence, shall conduct inspection and superv[ision]...

Article (72) Administrative Sanctions — preview: 1. The Establishment or the Ministry, each within its competence, may impose any of the following ad[ministrative sanctions]...

Article (73) Sanctions Register — preview: A register shall be established at the Establishment or the Ministry, each within its competence, in...

Article (74) Supervisory Committee — preview: A committee for the supervision of veterinary practices related to the provisions of this Law, its E[xecutive Regulations]...

Article (75) Grievance Against an Administrative Sanction — preview: 1. Anyone against whom a decision of an administrative sanction has been issued in implementation of...

Article (76) Non-prejudice to Criminal or Civil Liability — preview: Administrative accountability in accordance with the provisions of this Decree by Law shall not prej[udice]...

Criminal Penalties: Article (77) — preview: Whoever commits any of the following acts shall be punished by imprisonment and a fine of not less t[han]...

Article (78) — preview: Whoever commits any of the following acts shall be punished by imprisonment and a fine of not less t[han]...

Article (79) — preview: Whoever imports samples of any Veterinary Medical Product for research or marketing purposes without...

Article (80) — preview: Whoever commits any of the following acts shall be punished by imprisonment and a fine of not less t[han]...

Article (81) — preview: Whoever commits any of the following acts shall be punished by imprisonment and a fine of not less t[han]...

Article (82) — preview: Whoever commits any of the following acts shall be punished by imprisonment for a period of not less...

Article (83) — preview: Whoever commits any of the following acts shall be punished by a fine of not less than (AED 10,000)...

Article (84) Non-prejudice to a More Severe Penalty — preview: The application of the penalties stipulated in this Decree by Law shall not prejudice any more sever[e penalty]...

Article (85) Grievance against Resolutions Issued in Implementation of this Decree by Law — preview: Without prejudice to the text of Article (75) of this Decree by Law, a person against whom a decisio[n]...

Article (86) Judicial Enforcement Officers — preview: By a decision of the Minister of Justice in agreement with the Chairman or the Minister, or by a dec[ision]...

Article (87) Obtaining Necessary Licenses — preview: Obtaining the licenses stipulated in this Decree by Law shall not exempt from obtaining other licens[es]...

Article (88) Mutual Notification — preview: The Establishment, the Ministry, and the Competent Authority shall set a mechanism for mutual notifi[cation]...

Article (89) Regularization of Statuses — preview: All persons subject to the provisions of this Decree by Law at the time of its issuance shall regula[rize their status]...

Article (90) Fees — preview: The Cabinet shall, upon the proposal of the Minister of Finance, issue the necessary resolutions to...

Article (91) Executive Regulations and Implementing Resolutions for this Decree by Law — preview: 1. The Cabinet shall, upon the proposal of the Chairman and after coordination with the Ministry, th[e]...

Article (92) Delegation of Certain Competences — preview: The Cabinet may issue a resolution delegating some of the competences of the Ministry or the Establi[shment]...

Article (93) Repeals — preview: 1. Federal Law No. (9) of 2017 Regarding Veterinary Products is hereby repealed, and any other provi[sion]...

Article (94) Publication and Entry into Force of the Decree by Law — preview: This Decree by Law shall be published in the Official Gazette and shall enter into force as of 1 Jan[uary 2026]...

Translated in cooperation with