Executive Regulations of the Veterinary Preparations Law (System) in the Gulf Cooperation Council (GCC) States.

These Regulations, comprising 29 articles, prohibit the import, marketing, circulation, or release of any veterinary product unless it is registered and approved by the competent national authority. Personal imports of veterinary products through the internet or express mail are also prohibited without prior authorization. The competent authority in each GCC state is responsible for regulating and supervising veterinary products and related entities. Its responsibilities include (i) registering, suspending, or revoking registrations of veterinary companies, manufacturers, and products; (ii) licensing local manufacturers and warehouses; (iii) monitoring local and foreign manufacturers for compliance with Good Manufacturing Practices (cGMP), and warehouses for compliance with Good Storage Practices (GSP) and Good Distribution Practices (GDP); (iv) supervising veterinary products in the market and taking action based on international technical reports; (v) receiving and addressing reports concerning product quality, safety, and side effects from veterinary facilities, livestock projects, breeders, and individuals; (vi) issuing and publishing bans or restrictions on certain veterinary products or their use in specific animal species; (vii) setting and revising veterinary product pricing; (viii) approving advertising and issuing guidance to ensure product quality and safety; and (ix) issuing registration certificates and import release permits for veterinary products. Factories producing local veterinary products must obtain a license from the competent authority in accordance with the requirements set out in Article 4. Article 5 establishes the requirements and procedures for registering veterinary companies and manufacturers, requiring submission of proof of compliance with current Good Manufacturing Practices (cGMP), as required by Article 8. Registered companies are required to maintain a pharmacovigilance system, including monitoring and reporting adverse effects, submitting periodic safety updates, and communicating safety alerts and regulatory decisions related to their products. Article 9 sets out the conditions applicable to warehouses, particularly with regard to proper storage and distribution practices. The competent authority may prohibit importation, suspend handling, revoke registration, or order recall or withdrawal of veterinary products in the cases specified in Article 22. Chapter 3 establishes the framework for registering, evaluating, manufacturing, pricing, and controlling veterinary products. Companies must submit comprehensive technical documentation and comply with strict safety, efficacy, and quality requirements, with additional conditions for vaccines and serums. Any significant modification to a registered product requires prior approval or a new registration. The framework also allows limited importation for research purposes, imposes strict obligations for rapid reporting of global safety issues, and places tight restrictions on advertising unless officially approved. Veterinary products that are counterfeit, expired, spoiled, non-compliant with registration standards, or improperly stored must be disposed of. The inspecting authority is empowered to enforce the Veterinary Products Act and its implementing regulations to ensure (i) safety; (ii) insurance; (iii) quality; (iv) effectiveness; (v) proper storage and transportation conditions; and (vi) conformity with the approved registration dossier.