Article 3 of the Saudi Pharmaceutical Establishments Law
المادة 3 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
يشترط للترخيص لمركز الاستشارات الدوائية أو تحليل المستحضرات الصيدلانية والعشبية ما يأتي:
1- أن يكون المدير صيدليًّا متفرغاً مرخصاً له بمزاولة المهنة.
2- أن تتوافر في المركز 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 3 explained in plain English
This article sets two conditions for licensing a drug consultation or pharmaceutical and herbal product analysis center. Under Article 1, this center is a pharmaceutical establishment that provides drug consultations, analyzes products, studies bioavailability and bioequivalence, monitors the qualitative quality of medicines, and determines drug levels in biological fluids.
The two conditions are:
- The manager: must be a pharmacist, full-time, and licensed to practice the profession. A pharmacist is a holder of a bachelor's degree in pharmaceutical sciences or a Doctor of Pharmacy degree from a pharmacy college in the Kingdom, or an equivalent. This article does not require any particular nationality for the manager.
- The center: must meet the conditions and specifications set by the Regulations; the Law does not state these specifications and refers them to the Implementing Regulations.
These conditions implement Article 2, which bars opening any pharmaceutical establishment before obtaining the Authority's license in the owner's name. They differ from the conditions for a trading warehouse in Article 4, which allows the manager to be a pharmacist or a pharmacy technician.
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 company in Riyadh wants to set up a pharmaceutical product analysis center. It must appoint a full-time pharmacist licensed to practice as manager, and equip the center to the conditions and specifications set by the Regulations before it is granted 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 3 of the Saudi Pharmaceutical Establishments Law
Can the manager of a drug analysis center be a pharmacy technician?
No. The article requires the manager to be a full-time pharmacist licensed to practice the profession.
Must the center's manager be Saudi?
This article does not require Saudi nationality for the center's manager.
Where do I find the specifications of a drug consultation center?
The article refers the conditions and specifications to the Law's Implementing Regulations.
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 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.
- 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.