Article 28 of the Saudi Pharmaceutical Establishments Law
المادة 28 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
This article bars a pharmaceutical and herbal products factory from starting commercial-quantity production of products before they are registered.
Official text (Arabic)
This article has not been amended since the law was issued.
لا يجوز لمصنع المستحضرات الصيدلانية والعشبية أن يبدأ إنتاج المستحضرات الصيدلانية والعشبية بكميات تجارية إلا بعد تسجيلها.
This is the official Arabic wording, the only legally binding version. We do not translate the law itself; the explanation below is ours. Official source: Bureau of Experts at the Council of Ministers
Article 28 explained in plain English
This article regulates the timing of production at a pharmaceutical and herbal products factory: the factory may not start producing products in commercial quantities except after they are registered.
The restriction here is tied to the phrase "in commercial quantities": the text bars commercial production before registration, and does not address smaller quantities. The Law does not define commercial quantities in this article.
The practical effect is that it is not enough for a factory to be licensed; each product it produces commercially needs prior registration, so the factory must wait for registration to be completed before starting commercial production. The rule covers pharmaceutical and herbal products.
It is preceded by Article 27 on warehouses importing registered products that the factory does not supply, and followed by Article 29, which bars operating the factory other than to manufacture the products it is licensed to manufacture.
To see how this rule affects a particular situation, it is advisable to consult a lawyer who specializes in health and pharmaceutical regulation.
Practical example
A pharmaceutical factory in Riyadh developed a new product and wants to produce large quantities of it in preparation for launch. It may not start producing in commercial quantities before the product is registered.
Translated from our Arabic explanation with machine assistance. For guidance only; it does not replace advice from a lawyer on your situation.
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Frequently asked questions about Article 28 of the Saudi Pharmaceutical Establishments Law
Can a drug factory produce before the drug is registered?
It may not start producing in commercial quantities except after the product is registered.
Is the factory's license enough to produce?
No. Each product must also be registered before it is produced in commercial quantities.
Does the rule cover herbal products?
Yes. The text covers pharmaceutical and herbal products.
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- Article 5
To 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.
يشترط لمنح الترخيص لمصنع المستحضرات الصيدلانية والعشبية ما يأتي: 1- الحصول على ترخيص صناعي من الجهة المختصة. 2- أن يكون المدير الفني صيدليًّا سعوديًّا متفرغاً م
- Article 6
This 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.
يجب أن يكون لكل شركة أو مؤسسة لتصنيع المستحضرات الصيدلانية أو العشبية - لديها مصنع مسجل في المملكة - مكتب علمي، ويشترط لمنح الترخيص للمكتب ما يأتي: 1- أن يكون م
- Article 29
This article bars operating a pharmaceutical and herbal products factory other than to manufacture the products it is licensed to manufacture.
لا يجوز تشغيل مصنع المستحضرات الصيدلانية والعشبية في غير تصنيع المستحضرات الصيدلانية والعشبية المرخص له بتصنيعها.
- Article 30
This article requires a pharmaceutical and herbal products factory to apply good manufacturing practice principles.
يلتزم مصنع المستحضرات الصيدلانية والعشبية بتطبيق أسس ممارسة التصنيع الجيد.
The texts are reproduced from the official website of the Bureau of Experts at the Council of Ministers for reference; where they differ, the officially published Arabic text prevails. This content is not legal advice.