Article 6 of the Saudi Pharmaceutical Establishments Law
المادة 6 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 مديره صيدليًّا سعوديًّا متفرغاً مرخصاً له بمزاولة المهنة.
2- أن تتوافر فيه 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 6 explained in plain English
This article contains two provisions:
First: the scientific office is required. Every company or establishment manufacturing pharmaceutical or herbal products that has a factory registered in the Kingdom must have a scientific office. Under Article 1, the scientific office is a pharmaceutical establishment that provides scientific, technical and marketing information on products in the Kingdom.
Second: conditions for licensing the office.
- Its manager must be a full-time Saudi pharmacist licensed to practice the profession.
- It must meet the conditions and specifications set by the Regulations.
The text ties the requirement to having a factory registered in the Kingdom; the article does not address companies that have no registered factory. The nationality requirement here is the same as for the factory's technical manager under Article 5. The scientific office is a pharmaceutical establishment under Article 1, so it needs a license, and under Article 7 the license term for a pharmaceutical establishment is five years, renewable.
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 company has a factory registered in the Kingdom and markets its products to hospitals. It must have a licensed scientific office, managed by a full-time Saudi pharmacist licensed to practice the profession, and meeting the Regulations' specifications.
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 6 of the Saudi Pharmaceutical Establishments Law
Must a pharmaceutical company have a scientific office?
Yes, for every manufacturing company or establishment that has a factory registered in the Kingdom.
Who may manage the scientific office?
A full-time Saudi pharmacist licensed to practice the profession.
What does the scientific office do?
Under Article 1, the scientific office provides scientific, technical and marketing information on pharmaceutical and herbal products in the Kingdom.
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 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 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.