## [What is the Law of Pharmaceutical Establishments and Products in Kingdom Saudi Arabia?](/what-is-the-law-of-pharmaceutical-establishments-and-products-in-kingdom-saudi-arabia) 2 min read Your browser does not support the audio element. As the Saudi pharmaceutical market expands and aligns itself with international standards, the **Law of Pharmaceutical Establishments and Products (2023)** has emerged as the **primary legislation** governing medicinal products, herbal preparations, and pharmaceutical operations in the Kingdom. This law, issued under **Royal Decree No. M/108, dated 19/11/1444 AH (corresponding to June 2023)**, is enforced by the **Saudi Food and Drug Authority (SFDA)** and provides a comprehensive legal foundation for drug regulation in the country. ## Scope of the Law The Law of Pharmaceutical Establishments and Products (2023) establishes SFDA’s full Regulatory authority across the lifecycle of medicinal products—covering: - Manufacturing, importing, and exporting - Product registration and marketing authorization - Distribution and retail operations - Advertising and promotional oversight - Licensing of pharmaceutical establishments - Pharmacovigilance obligations - Inspection and enforcement procedures This law applies not only to chemical drugs but also to **biologicals, biosimilars, herbal products, homeopathic medicines, radiopharmaceuticals, and blood-derived products**. ## Key Regulatory Requirements for Compliance **1. Mandatory Product Registration** All medicinal products must be registered with the SFDA through its **Drug Registration System (DUR)**. The CTD (Common Technical Document) format is required, ensuring harmonization with ICH standards. Products cannot be marketed without valid SFDA approval. **2. Licensing of Entities** Manufacturers, importers, distributors, wholesalers, and pharmacies must obtain SFDA-issued licenses. Facilities are subject to periodic GMP audits and Regulatory inspections. **3. Local Representation** Foreign manufacturers must appoint a **local authorized representative or agent** responsible for Regulatory submissions, safety monitoring, and liaising with the SFDA. **4. GMP Compliance** Manufacturers—both domestic and international—must comply with **SFDA’s GMP Guidelines**, based on WHO and PIC/S standards. SFDA may conduct its own inspections or recognize certifications from trusted Regulatory authorities. **5. Pharmacovigilance Obligations** Marketing Authorization Holders (MAHs) must: - Appoint a **Qualified Person for Pharmacovigilance (QPPV)** based in Saudi Arabia - Maintain a functional **pharmacovigilance system** - Submit **Periodic Safety Update Reports (PSURs)** and **Risk Management Plans (RMPs)** - Report adverse drug reactions using the **Tiqyam** e-system **6. Labeling and Promotion** SFDA mandates that product labels and patient information leaflets (PILs) be provided in both **Arabic and English**. All promotional activities require **pre-approval**, and restrictions apply to advertising prescription medications directly to consumers. ### Alignment with International Best Practices The 2023 law reinforces Saudi Arabia’s commitment to international Regulatory convergence. It mirrors the frameworks of leading health authorities such as the **U.S. FDA**, **EMA**, and **Health Canada**. Moreover, it integrates with the **GCC Central Drug Registration system**, providing pharmaceutical companies with a gateway to broader Gulf markets—though SFDA still requires local approval post-GCC registration. ### Strategic Impact on Regulatory Professionals For Regulatory affairs teams and consultants, the 2023 legislation serves as a definitive guide for structuring market entry and compliance strategies. It emphasizes risk-based approaches, lifecycle management, and harmonized dossier submissions—necessitating a shift from transactional registration processes to **long-term regulatory planning**. ### Need Support Navigating SFDA Regulations? Whether you’re preparing CTD dossiers, planning pharmacovigilance setups, or seeking licensing support, **Freyr Solutions** offers end-to-end **Regulatory Affairs services in Kingdom of Saudi Arabia**. Our in-region experts help pharmaceutical companies ensure **SFDA compliance**, expedite **product registrations,** and stay ahead of **Regulatory updates**. [**Connect with our team**](https://saudiarabia.freyrsolutions.com/contact-us) to simplify your entry into the Saudi market and optimize Regulatory success across the GCC.