Article 5 of the Saudi Pharmaceutical Establishments Law
المادة 5 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 مرخصاً له بمزاولة المهنة.
3- أن تتوافر في المصنع الشروط والمواصفات التي تحددها اللائحة.
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 5 explained in plain English
This article sets three conditions for granting a license to a pharmaceutical and herbal products factory:
- Industrial license: the factory must obtain an industrial license from the competent authority. The Authority's license does not replace the industrial license, and the text does not name that authority.
- Technical manager: must be a Saudi pharmacist, full-time, and licensed to practice the profession.
- The factory: must meet the conditions and specifications set by the Regulations.
The second condition is stricter than its counterpart for a trading warehouse: Article 4 accepts a pharmacist or pharmacy technician as warehouse manager with no nationality requirement, while for a factory a Saudi pharmacist is required. This article contains no exception to the nationality requirement.
The three conditions apply together, so the license is not granted if only some are met. It is followed in Article 6 by the requirement that every company with a factory registered in the Kingdom have a scientific office.
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 Saudi company plans to build a herbal products factory in the industrial city in Riyadh. It must obtain an industrial license from the competent authority, appoint a full-time licensed Saudi pharmacist as technical manager, and meet the Regulations' specifications before the Authority grants it the license.
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 5 of the Saudi Pharmaceutical Establishments Law
Must the technical manager of a medicine factory be Saudi?
Yes. The article requires a full-time Saudi pharmacist licensed to practice the profession.
Is the Authority's license enough to run a medicine factory?
No. One of the licensing conditions is obtaining an industrial license from the competent authority, in addition to the other conditions.
Can the factory's technical manager be a pharmacy technician?
No. The text requires a pharmacist.
More articles on Licensing of Pharmaceutical Establishments
- Article 2
This article bars opening any pharmaceutical establishment before obtaining the necessary license from the Saudi Food and Drug Authority in the owner's name.
لا يسمح بفتح منشأة صيدلية إلا بعد الحصول على الترخيص اللازم من الهيئة باسم مالك المنشأة.
- Article 3
To 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.
يشترط للترخيص لمركز الاستشارات الدوائية أو تحليل المستحضرات الصيدلانية والعشبية ما يأتي: 1- أن يكون المدير صيدليًّا متفرغاً مرخصاً له بمزاولة المهنة. 2- أن تتوا
- Article 4
To 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.
يشترط للترخيص لمستودع الاتجار بالمستحضرات الصيدلانية والعشبية ما يأتي: 1- أن يكون المدير صيدليًّا أو فني صيدلة متفرغاً ومرخصاً له بمزاولة المهنة. 2- أن تتوافر ف
- 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 7
This article sets the license term for a pharmaceutical establishment at five years, renewable.
مدة الترخيص للمنشأة الصيدلية خمس سنوات قابلة للتجديد.
- Article 8
This 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.
تستوفى من المنشآت الصيدلية الآتية الرسوم الموضحة أمام كل منها عند منح الترخيص أو تجديده: المنشأة الصيدلية الرسم مصنع المستحضرات الصيدلانية والعشبية 10.000 ريال
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.