Article 8 of the Saudi Pharmaceutical Establishments Law
المادة 8 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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
مستودع الاتجار بالمستحضرات الصيدلانية والعشبية 3.000 ريال
مركز الاستشارات الدوائية أو تحليل المستحضرات الصيدلانية والعشبية 1.000 ريال
المكتب العلمي 1.000 ريال
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 8 explained in plain English
This article sets the fees charged to pharmaceutical establishments when the license is granted or renewed:
- Factory for pharmaceutical and herbal products: SAR 10,000.
- Warehouse trading in pharmaceutical and herbal products: SAR 3,000.
- Drug consultation or product analysis center: SAR 1,000.
- Scientific office: SAR 1,000.
These fees are fixed in the Law itself as set amounts for each type, so according to the text they do not change with the establishment's size or number of branches. They are paid on two occasions: when the license is first granted, and on each renewal. Since Article 7 makes the license term five years, renewable, the fee is due with each renewal.
The article does not state fees for a pharmacy or an herbal products sales establishment, because they are not within the definition of "pharmaceutical establishment" in Article 1, and the article is limited to the four types listed.
These fees also relate only to licensing the establishment itself, not to the products the establishment deals in.
Practical example
A medicine distribution warehouse in Makkah obtained its license and paid SAR 3,000. When the license term ends after five years and it applies for renewal, the same fee of SAR 3,000 is charged again.
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 8 of the Saudi Pharmaceutical Establishments Law
What is the fee for licensing a medicine factory?
SAR 10,000 when the license is granted or renewed.
What is the fee for licensing a medicine warehouse?
SAR 3,000 when the license is granted or renewed.
What is the fee for licensing a scientific office?
SAR 1,000, the same fee as for a drug consultation or analysis center.
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 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.
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.