In force
Saudi Pharmaceutical Establishments Law
نظام المنشآت والمستحضرات الصيدلانية والعشبية
Regulates pharmaceutical and herbal establishments and their products in Saudi Arabia. It concerns pharmacies, manufacturers, distributors and the authorities that license and supervise them.
- Articles
- 42
- In force
- 42
- Amended
- 0
- Issued
- 22/8/1441 AH
Issued by: مرسوم ملكي رقم (م/108) وتاريخ 1441/8/22هـ · قرار مجلس الوزراء رقم (534) وتاريخ 1441/8/21هـ
Each article shows the official Arabic text, which is the only legally binding version, followed by our plain-English explanation.
Browse Pharmaceutical Establishments Law by topic
Definitions of Pharmaceutical Preparations and Establishments4 articlesLicensing of Pharmaceutical Establishments8 articlesPharmacists and Staff of Pharmaceutical Establishments2 articlesRegistration of Pharmaceutical and Herbal Preparations5 articlesDrug Pricing and Profit Margins3 articlesSale and Circulation of Drugs and Herbs6 articlesImport and Export of Pharmaceutical Preparations4 articlesDrug Factories and Good Manufacturing5 articlesAdvertising Drugs and Preparations2 articlesAdulterated and Spoiled Drugs3 articlesInspection of Pharmaceutical Establishments1 articlePenalties for Drug and Herbal Violations4 articlesPharmacy Law Violations Committee and Grievance2 articles
Articles of the Saudi Pharmaceutical Establishments Law
- Article 1This article defines the key terms of the Law, such as pharmacist, pharmacy technician, pharmaceutical and herbal product, adulterated and spoiled products, and the types of establishments.
- Article 2This article bars opening any pharmaceutical establishment before obtaining the necessary license from the Saudi Food and Drug Authority in the owner's name.
- Article 3To license a drug consultation or product analysis center, this article requires its manager to be a full-time licensed pharmacist and the center to meet the conditions in the Regulations.
- Article 4To license a product trading warehouse, this article requires it to be managed by a full-time licensed pharmacist or pharmacy technician and to meet the conditions in the Regulations.
- Article 5To license a product factory, this article requires an industrial license, a full-time licensed Saudi pharmacist as technical manager, and compliance with the conditions in the Regulations.
- Article 6This article requires every manufacturing company or establishment with a factory registered in the Kingdom to have a scientific office, and sets the conditions for licensing it.
- Article 7This article sets the license term for a pharmaceutical establishment at five years, renewable.
- Article 8This article sets the fees for granting or renewing a pharmaceutical establishment license: SAR 10,000 for a factory, SAR 3,000 for a warehouse, SAR 1,000 for a center and SAR 1,000 for a scientific office.
- Article 9This article bars a pharmaceutical establishment from employing pharmacists, pharmacy technicians or other health practitioners unless they are licensed to practice the profession.
- Article 10This article limits work in promoting and informing about pharmaceutical and herbal products to a full-time licensed Saudi pharmacist, and lets the President waive the nationality condition when there are not enough Saudi pharmacists.
- Article 11This article bases the price of a pharmaceutical or herbal product on the factory price or the export price to the Kingdom, and requires the Authority to review prices periodically.
- Article 12This article sets the profit percentages for a trading warehouse, a pharmacy and an herbal products sales establishment on a product's price, according to factory or export price brackets.
- Article 13This article bars selling samples of pharmaceutical and herbal products prepared to introduce the product.
- Article 14This article limits retail sale of pharmaceutical products to pharmacies, and herbal products to pharmacies and herbal establishments, except what the President decides may be sold elsewhere.
- Article 15This article bars a pharmaceutical establishment from holding products without documents proving their source and quantities, and requires manufacturers and warehouses to replace products with only one month of shelf life left.
- Article 16This article requires anyone who dispensed or sold an adulterated, spoiled, expired or unregistered product to notify the Authority as soon as they learn of it and to refund the buyer's price.
- Article 17This article bars circulating pharmaceutical and herbal products before they are registered with the Saudi Food and Drug Authority.
- Article 18This article sets the registration term for a pharmaceutical or herbal product at five years, renewable, with a fee of SAR 1,000 for each strength, pharmaceutical form or package.
- Article 19This article bars selling registered pharmaceutical and herbal products except after the Authority prices them and in the packages it specifies.
- Article 20This article provides for committees formed by the President's decision to register product factories and their products, and refers registration conditions and committee work to the Regulations and members' remuneration to the Board.
- Article 21This article requires registered product factories in the Kingdom and the warehouses representing them to supply their registered products, however low their price or consumption.
- Article 22This article bars exporting pharmaceutical and herbal products except after the approval of the Saudi Food and Drug Authority.
- Article 23This article lets the Authority, when necessary, allow the import of pharmaceutical and herbal products that are not prohibited before they are registered.
- Article 24This article lets the President cancel the registration of any factory or product and stop its circulation on the registration committee's recommendation, and lets the Authority approve re-exporting or destroying it.
- Article 25This article lets the Authority allow non-prohibited pharmaceutical and herbal products to be brought in for personal use, with a medical report and in limited quantities.
- Article 26This article bars trading warehouses from selling products to anyone other than a pharmacy, an herbal products sales establishment and a licensed health establishment, subject to the Article 14 exception.
- Article 27This article lets trading warehouses import registered products that the producing factory does not supply, provided the Authority approves.
- Article 28This article bars a pharmaceutical and herbal products factory from starting commercial-quantity production of products before they are registered.
- Article 29This article bars operating a pharmaceutical and herbal products factory other than to manufacture the products it is licensed to manufacture.
- Article 30This article requires a pharmaceutical and herbal products factory to apply good manufacturing practice principles.
- Article 31This article subjects advertising of pharmaceutical and herbal products to the controls set by the Implementing Regulations.
- Article 32This article provides that a pharmaceutical establishment is liquidated under the procedures set by the Implementing Regulations.
- Article 33The article gives the Authority power to inspect establishments and products through inspectors named by the CEO, who may seize violating products, hold them, take samples and recommend destruction at the violator's expense.
- Article 34The article lists the acts that violate the law, including adulterating products, selling or importing adulterated, spoiled or unregistered products, false promotion and counterfeit packaging.
- Article 35The article sets penalties of a fine up to SAR 5 million, closure up to 180 days or license cancellation, rising to prison up to 10 years or a fine up to SAR 10 million for adulteration offenses.
- Article 36The article lets the Authority impose fines below SAR 100,000 on scientific offices and centers, below SAR 200,000 on warehouses and below SAR 300,000 on factories, under a schedule issued by the Board.
- Article 37The article creates a committee of at least three members, one of them a legal adviser, to hear violations and grievances; its decisions may be challenged before the Administrative Court within 60 days.
- Article 38The article requires violations covered by paragraph (2) of Article 35 to be referred to the Public Prosecution for investigation and then to the competent court.
- Article 39The article allows the judgment or decision imposing a penalty to include publishing its operative part at the violator's expense in a local newspaper or other suitable means, once it is final or unchallengeable.
- Article 40The article requires the Authority's Board to issue the Implementing Regulations within 120 days of the law's publication in the Official Gazette, to take effect after the law comes into force.
- Article 41The article provides that this law replaces the Pharmaceutical Establishments and Products Law issued by Royal Decree No. M/31 of 1425 AH, and repeals anything that conflicts with it.
- Article 42The article provides that the law takes effect 120 days after its publication in the Official Gazette.