Legislation Details
- Full Title: Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments
- Law Type: Federal Decree-Law
- Law Number: [21] of 2025
- Issued Date: 01 Oct 2025
- Effective Date: 01 Jan 2026
- Official Gazette: No. 809
- Sector: Healthcare
- Status: Active
- Number of Articles: 206
- Chapters/Parts: 0
- Amendments: 0
Summary
This Federal Decree-Law regulates the veterinary medical products and veterinary pharmaceutical establishments in the United Arab Emirates. It establishes a comprehensive framework for the marketing authorization, manufacturing, import, export, and distribution of veterinary medical products, as well as the licensing and regulation of various veterinary pharmaceutical establishments. The law aims to ensure the safety, efficacy, and quality of veterinary medical products, promote investment in the veterinary medical industries sector, and strengthen the UAE's position as a regional hub for the trade and production of these products. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025) The law is of significant importance for businesses and individuals involved in the veterinary medical industry in the UAE, as it sets out detailed requirements and obligations for the marketing, manufacturing, and distribution of veterinary medical products. It also establishes a robust regulatory framework, including licensing requirements, inspection and enforcement mechanisms, and penalties for non-compliance. Compliance with this law is crucial for companies seeking to operate in the UAE's veterinary medical sector. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025)
What is the scope and purpose of this law?
The scope of this Federal Decree-Law covers veterinary medical products, which include devices, medicinal and medical products intended for use in or on an animal body, as well as veterinary pharmaceutical establishments operating in the UAE. The law aims to regulate the marketing authorization, manufacturing, import, export, and distribution of veterinary medical products, and to establish a licensing and regulatory framework for various types of veterinary pharmaceutical establishments. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 1, 2)
What are the key definitions under this law?
The law provides the following key definitions:
- Veterinary Medical Product: Devices, medicinal and medical products intended for use in or on an animal body. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 1)
- Veterinary Medicinal Product: A substance, combination of substances or an input material prepared for the treatment or prevention of a disease, for the diagnosis of medical conditions, or for the restoration, correction, or modification of physiological functions or the structure of an animal. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 1)
- Veterinary Biological Products: Veterinary Medicinal Products obtained through biotechnological techniques from a living organism or produced industrially in a way that mimics the biological origin. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 1)
- Veterinary Complementary Products: Products used to improve the health condition of animals, support body functions, enhance digestion, and promote growth or performance, without having any therapeutic uses. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 1)
- Veterinary Medical Device: A Veterinary Medical Product in the form of a substance, device, instrument, apparatus, implant, reagent, or system, including its accessories and operating software. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 1)
- Marketing Authorization: The approval granted by the Establishment to a licensed legal person in the State to market a specific Veterinary Medical Product. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 1)
- Veterinary Pharmaceutical Establishments: The establishments listed in Clause (2) of Article (2) of this Decree by Law. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 1)
What are the main obligations and requirements?
The key obligations and requirements under this law include:
- Obtaining marketing authorization from the Emirates Drug Establishment for the sale and distribution of veterinary medical products in the UAE. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 6-17)
- Complying with good manufacturing practices and other quality standards for the production of veterinary medical products. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 29-30)
- Obtaining the necessary licenses and permits for the import, export, or re-export of veterinary medical products and consignments. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 33-35)
- Adhering to requirements for the circulation, prescription, and sale of veterinary medical products. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 37-42)
- Complying with regulations for the promotion and advertising of veterinary medical products. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 44-47)
- Establishing a national system for tracking and tracing veterinary medical products. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 51)
What licensing, registration, or approval requirements exist?
The law establishes the following licensing and registration requirements for various veterinary pharmaceutical establishments:
- Licensing of veterinary pharmacies, veterinary medical warehouses, veterinary medical products manufacturing facilities, contract manufacturing organizations, marketing offices, veterinary biobanks, pharmaceutical consultancy offices, pharmaceutical laboratories, contract research and development organizations, and bioequivalence centers. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 57-66)
- Obtaining marketing authorization from the Emirates Drug Establishment for the sale and distribution of veterinary medical products in the UAE. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 6-17)
- Obtaining import, export, or re-export approvals or permits for veterinary medical product consignments. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 33-35)
- Obtaining approval for the advertising of veterinary medical products. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 45-47)
What rights and protections does this law provide?
The law does not explicitly mention any specific rights or protections granted to individuals or businesses. The focus of the legislation is on establishing a regulatory framework for the marketing, manufacturing, and distribution of veterinary medical products, as well as the licensing and oversight of veterinary pharmaceutical establishments. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025)
Which authorities or bodies are responsible for enforcement?
The key authorities and bodies responsible for the enforcement of this law are:
- The Ministry of Climate Change and Environment, which oversees the implementation of the law. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 1)
- The Emirates Drug Establishment, which is responsible for granting marketing authorizations, licenses, and permits, as well as supervising and inspecting veterinary pharmaceutical establishments. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 1, 74)
- The Competent Authority, which is the local authority concerned with veterinary medical products and veterinary pharmaceutical establishments in each Emirate. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 1)
- The Supervisory Committee, which is responsible for overseeing the implementation of administrative sanctions. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 74)
What are the penalties for non-compliance?
The law prescribes the following criminal penalties for non-compliance:
- Imprisonment for a period not exceeding 5 years and/or a fine not exceeding AED 1,000,000 for the manufacture, import, export, or re-export of veterinary medical products without a license. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 77)
- Imprisonment for a period not exceeding 3 years and/or a fine not exceeding AED 500,000 for the sale, promotion, or distribution of veterinary medical products without a marketing authorization. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 78)
- Imprisonment for a period not exceeding 2 years and/or a fine not exceeding AED 300,000 for the violation of any other provision of the law or its implementing regulations. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 79-83)
What fees, charges, or financial provisions are specified?
The law states that fees shall be imposed for the various licenses, permits, and approvals issued under this Decree-Law, but it does not specify the exact amounts of these fees. The Executive Regulations of the law will determine the applicable fees. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 90)
What exemptions or exceptions apply?
The law does not mention any specific exemptions or exceptions to its provisions. It applies broadly to all veterinary medical products and veterinary pharmaceutical establishments operating in the UAE. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025)
How are disputes resolved under this law?
The law provides for the following dispute resolution mechanisms:
- Grievances against administrative sanctions imposed under the law can be submitted to the Supervisory Committee. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 75)
- Grievances against resolutions issued in the implementation of this Decree-Law can be filed with the competent court. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 85)
What are the key deadlines and time limits?
The law does not specify any deadlines or time limits, apart from the effective date of the Decree-Law, which is 01 January 2026. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 94)
How does this law interact with other UAE legislation?
This Federal Decree-Law is related to and interacts with the following UAE legislation:
- Federal Law No. (1) of 1972 Regarding the Competences of Ministries and the Powers of Ministers, as amended
- Federal Law No. (10) of 2002 Regarding the Practice of the Veterinary Medicine Profession, as amended
- Federal Law No. (7) of 2015 Regarding the Control of Prohibited Substances in the Field of Horse Racing and Equestrian Sports
- Federal Law No. (9) of 2017 Regarding Veterinary Products, as amended
- Federal Decree by Law No. (30) of 2021 Regarding Combating Narcotics and Psychotropic Substances, as amended
- Federal Decree by Law No. (28) of 2023 Establishing the Emirates Drug Establishment
- Federal Decree by Law No. (38) of 2024 Regarding Medical Products, the Pharmacy Profession, and Pharmaceutical Establishments
(Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025)
When did this law come into effect?
This Federal Decree-Law comes into effect on 01 January 2026, as stated in Article 94. (Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments, 2025, Art. 94)
Source Documents
This article analyses Federal Decree by Law Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments for legal research and educational purposes. For the purpose of interpretation and application, reference must be made to the original Arabic text. In case of conflict, the Arabic text prevails. This does not constitute legal advice.