Article 30 of the Saudi Pharmaceutical Establishments Law
المادة 30 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
This article requires a pharmaceutical and herbal products factory to apply good manufacturing practice principles.
Official text (Arabic)
This article has not been amended since the law was issued.
يلتزم مصنع المستحضرات الصيدلانية والعشبية بتطبيق أسس ممارسة التصنيع الجيد.
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 30 explained in plain English
This article places a general obligation on the pharmaceutical and herbal products factory, which is to apply good manufacturing practice principles.
The text is content to state the obligation, and does not give the details of these principles, their source, the body that sets them, or how their application is verified. Anyone who needs the detailed requirements must consult what the competent bodies issue on the subject; nothing about them can be gathered from the text of this article.
The obligation matters because it is continuing: it is not a condition met only at licensing, but a duty that accompanies the factory's work.
This article is among the obligations placed on factories:
- Article 29: the factory may not be operated other than for the products it is licensed to manufacture.
- This article: applying good manufacturing practice principles.
It is followed by Article 31, which subjects advertising of products to the controls set by the Regulations.
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
An herbal products factory in Qassim obtained its license and began production. For as long as it operates, it remains bound to apply good manufacturing practice principles in its production.
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 30 of the Saudi Pharmaceutical Establishments Law
What is meant by good manufacturing practice?
The article requires the factory to apply good manufacturing practice principles without detailing those principles in its text.
Is the good manufacturing requirement a condition only at licensing?
The text sets an obligation on the factory to apply these principles without limiting it to the time of licensing.
Are herbal products factories bound by good manufacturing?
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 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.
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.