Federal Decree by Law No. (21) of 2025 Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments
Federal Decree by Law No. (21) of 2025
This decree-law establishes the federal regime for veterinary medical products and veterinary pharmaceutical establishments, covering product authorisation, manufacture, import/export, distribution, storage, advertising, quality, pharmacovigilance, licensing, inspection and enforcement.
Overview
What this legislation covers
This decree-law establishes the federal regime for veterinary medical products and veterinary pharmaceutical establishments, covering product authorisation, manufacture, import/export, distribution, storage, advertising, quality, pharmacovigilance, licensing, inspection and enforcement.
Who or what it applies to
- Veterinary medical-product manufacturers and marketing-authorisation holders.
- Veterinary pharmaceutical factories, warehouses, pharmacies and other regulated establishments.
- Importers, exporters, distributors and logistics/storage operators.
- Veterinarians and professionals handling regulated products where duties are assigned by law.
- Competent federal/local regulators and inspection bodies.
Key points
Important points at a glance
Official metadata records issuance on 1 October 2025 and effect from 1 January 2026.
Creates a comprehensive federal regulatory system for veterinary medical products.
Regulates veterinary pharmaceutical establishments and activities throughout the supply chain.
Requires marketing/product authorisation before regulated products may be placed on the market, subject to statutory exceptions.
Regulates manufacture, quality control and good-practice requirements.
Regulates import, export, transit, distribution, wholesale, retail and storage.
Controls labelling, packaging, information and advertising/promotion.
Addresses veterinary biologicals, vaccines and other specialised product categories.
Regulates prescription/dispensing and professional responsibilities where applicable.
Creates product-safety monitoring and reporting obligations.
Provides rules for recalls, withdrawals, destruction and handling of defective or unsafe products.
Requires establishment licensing and qualified technical/professional personnel.
Provides regulator inspection, sampling, records and enforcement powers.
Creates administrative and criminal consequences for violations.
Businesses must check transition rules for products/establishments licensed under predecessor legislation.
Practical explanation
Understanding the law
Purpose and practical effect
This decree-law establishes the federal regime for veterinary medical products and veterinary pharmaceutical establishments, covering product authorisation, manufacture, import/export, distribution, storage, advertising, quality, pharmacovigilance, licensing, inspection and enforcement.
Who and what the law applies to
- Veterinary medical-product manufacturers and marketing-authorisation holders.
- Veterinary pharmaceutical factories, warehouses, pharmacies and other regulated establishments.
- Importers, exporters, distributors and logistics/storage operators.
- Veterinarians and professionals handling regulated products where duties are assigned by law.
- Competent federal/local regulators and inspection bodies.
Important definitions
- Veterinary Medical Product: a regulated product intended for veterinary prevention, diagnosis, treatment or physiological effect under the decree-law.
- Veterinary Pharmaceutical Establishment: an establishment licensed for regulated manufacture, import, distribution, dispensing or related activities.
- Marketing Authorisation: regulatory approval permitting a veterinary product to be marketed.
- Responsible Professional: the licensed/qualified person charged with statutory professional duties at an establishment.
- Recall: regulator or company action to remove a product from the market because of safety, quality or legal concerns.
Main rights, duties and legal consequences
- Only authorised products may be marketed where authorisation is required.
- Only licensed establishments may carry out regulated pharmaceutical activities.
- Regulators may inspect facilities, records and products and may take samples.
- Licensees must report safety/quality problems and cooperate with recalls and corrective actions.
Practical compliance / procedure checklist
- Classify the proposed product under the decree-law.
- Obtain establishment licensing before carrying out the relevant activity.
- Submit the required product/marketing-authorisation dossier before commercialisation.
- Implement quality, storage, transport, traceability and pharmacovigilance systems.
- Use approved labels, product information and advertising only.
- Report serious safety/quality issues and execute regulator-approved recalls when required.
- Maintain records and prepare for inspection throughout the licence lifecycle.
Important dates and deadlines
- Issued: 1 October 2025.
- Effective: 1 January 2026.
- Specific application, renewal, reporting, recall and transition periods depend on the relevant article and implementing decisions.
- Existing licence/product transition deadlines must be checked against the decree-law and any regulator circulars.
Enforcement and legal exposure
The regulator may use product recalls, seizure, suspension/cancellation of licences or marketing authorisations, establishment measures and statutory penalties. Exact sanctions depend on the particular violation.
Practical scenarios
- A distributor cannot assume a human pharmaceutical licence covers veterinary products; establishment scope must match the veterinary decree-law.
- A new veterinary vaccine requires the correct product authorisation before lawful marketing.
- A safety signal after launch may trigger pharmacovigilance reporting and a regulator-directed recall.
- An imported batch must meet product registration, customs and quality documentation requirements.
Current-law interaction
No amendment identified in the official source reviewed. Because the law became effective in 2026, current Emirates Drug Establishment / competent authority implementing decisions should be checked for operational requirements.
Research status
Legal-status and source verification for this package was carried out on 2026-09-07. UAE federal legislation often operates together with Cabinet resolutions, Executive Regulations, ministerial decisions, local Health/competent-authority rules and later amendments. The current official source should be rechecked before a live filing, licence application, clinical decision, enforcement step or court submission.
Practical notes
- Use the current official Arabic text for interpretation and application; the English package is a structured legal-information rendering.
- Verify the latest consolidated law, Executive Regulation, Cabinet/ministerial decisions and relevant Emirate-level rules immediately before case-specific reliance.
- Exact penalties, thresholds, exceptions, consent rules and procedural deadlines must be checked against the current article and implementing instrument.
- The supplied cover artwork is editorial artwork and does not constitute an official UAE Government publication or legal-status certificate.
Legislation text
Text and provisions
Official-text notice. This file is a comprehensive structured English legal-information rendering based on the sources listed in this package. It is not represented as the controlling verbatim English text. The official Arabic text prevails for interpretation and application. Exact offences, penalties, thresholds, exceptions, licences, consent requirements and deadlines must be checked against the current official article and implementing instrument.
Federal Decree by Law No. (21) of 2025 Regarding Veterinary Medical Products and Veterinary Pharmaceutical Establishments
Verified legislative metadata
| Instrument | Federal Decree by Law No. (21) of 2025 |
|---|---|
| Issued | 2025-10-01 |
| Effective | 2026-01-01 |
| Status | Active / in force |
| Official Gazette | Official Gazette No. 809 (Annex 1) |
| Official source | UAE legislation source |
Purpose and scope
This decree-law establishes the federal regime for veterinary medical products and veterinary pharmaceutical establishments, covering product authorisation, manufacture, import/export, distribution, storage, advertising, quality, pharmacovigilance, licensing, inspection and enforcement.
Structured legislative map
Definitions and objectives
Defines veterinary medical products, establishments, regulatory authorities and core product concepts.
Product classification
Determines which products fall within the decree-law and how categories are regulated.
Marketing authorisation
Requires product registration/authorisation and regulates application, renewal, variation and cancellation.
Manufacturing
Licenses manufacturers and imposes quality, technical and good-manufacturing controls.
Import and export
Regulates cross-border movement, permits, documentation and customs coordination.
Distribution and wholesale
Requires approved channels, traceability and storage/transport conditions.
Veterinary pharmacies and establishments
Regulates establishment licensing, premises, responsible personnel and permitted activities.
Prescription and dispensing
Controls supply/use of products that require professional prescription or supervision.
Labelling and advertising
Regulates product information, claims, packaging and promotion.
Quality and testing
Allows sampling/testing and establishes compliance requirements for quality, safety and efficacy.
Pharmacovigilance
Requires monitoring, reporting and action on safety signals/adverse events.
Recall and disposal
Regulates recall, suspension, withdrawal and safe disposal of products.
Inspection and records
Provides regulatory inspection powers and record-retention obligations.
Administrative measures
Allows suspension, closure, cancellation, seizure, recall or other enforcement actions.
Penalties
Creates offences and penalties for serious non-compliance.
Transitional and final provisions
Regulates existing products/establishments and commencement.
Key statutory points
- Official metadata records issuance on 1 October 2025 and effect from 1 January 2026.
- Creates a comprehensive federal regulatory system for veterinary medical products.
- Regulates veterinary pharmaceutical establishments and activities throughout the supply chain.
- Requires marketing/product authorisation before regulated products may be placed on the market, subject to statutory exceptions.
- Regulates manufacture, quality control and good-practice requirements.
- Regulates import, export, transit, distribution, wholesale, retail and storage.
- Controls labelling, packaging, information and advertising/promotion.
- Addresses veterinary biologicals, vaccines and other specialised product categories.
- Regulates prescription/dispensing and professional responsibilities where applicable.
- Creates product-safety monitoring and reporting obligations.
- Provides rules for recalls, withdrawals, destruction and handling of defective or unsafe products.
- Requires establishment licensing and qualified technical/professional personnel.
- Provides regulator inspection, sampling, records and enforcement powers.
- Creates administrative and criminal consequences for violations.
- Businesses must check transition rules for products/establishments licensed under predecessor legislation.
Amendments and interaction with other legislation
No amendment identified in the official source reviewed. Because the law became effective in 2026, current Emirates Drug Establishment / competent authority implementing decisions should be checked for operational requirements.
Legal-reading rule
This package is designed for website publication, internal research and client-facing orientation. It maps the law's operative subject matter and current regulatory context, but a paraphrase cannot replace the statutory wording. Where the outcome depends on a defined term, licence category, medical condition, consent requirement, penalty, exception, transition rule or deadline, open the current Arabic article and the relevant Executive Regulation or competent-authority decision before relying on it.
Verification
Official source & references
Official legislation sourcehttps://uaelegislation.gov.ae/en/legislations/3942Open ↗Official Gazette: Official Gazette No. 809 (Annex 1)
This page is a research and educational resource. Legislation can be amended, repealed, supplemented by regulations or interpreted by courts and authorities. Obtain advice before relying on it for a live matter.