Article 29 of the Saudi Pharmaceutical Establishments Law
المادة 29 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
This article bars operating a pharmaceutical and herbal products factory other than to manufacture the products it is licensed to manufacture.
Official text (Arabic)
This article has not been amended since the law was issued.
لا يجوز تشغيل مصنع المستحضرات الصيدلانية والعشبية في غير تصنيع المستحضرات الصيدلانية والعشبية المرخص له بتصنيعها.
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 29 explained in plain English
This article sets the scope of work of a pharmaceutical and herbal products factory: it may not be operated other than to manufacture the products it is licensed to manufacture.
In practice, this means:
- The factory is operated only to manufacture pharmaceutical and herbal products.
- It is limited to those of them that it is licensed to manufacture.
The license therefore determines what the factory may produce, and it may not be exceeded. The text mentions no exceptions, and does not explain how to add new products to the scope of the license.
This article is among the provisions specific to factories:
- Article 28: bars production in commercial quantities before the product is registered.
- Article 30: requires the factory to apply good manufacturing practice principles.
The evident purpose of these provisions is that what is produced at the factory stays within what the competent authority licensed and its oversight.
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 businessman owns a factory licensed to manufacture pain-relief tablets and wanted to use the production lines to make another product that it is not licensed to manufacture. He may not do so, because the factory may be operated only to manufacture the products it is licensed to manufacture.
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 29 of the Saudi Pharmaceutical Establishments Law
Can a drug factory be used to make other products?
No. It may not be operated other than to manufacture the pharmaceutical and herbal products it is licensed to manufacture.
What determines what a factory produces?
The license; the factory is limited to the products it is licensed to manufacture.
Does the rule cover herbal products factories?
Yes. The text covers pharmaceutical and herbal products factories.
More articles on Drug Factories and Good Manufacturing
- 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 28
This article bars a pharmaceutical and herbal products factory from starting commercial-quantity production of products before they are registered.
لا يجوز لمصنع المستحضرات الصيدلانية والعشبية أن يبدأ إنتاج المستحضرات الصيدلانية والعشبية بكميات تجارية إلا بعد تسجيلها.
- 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.