Article 2 of the Saudi Pharmaceutical Establishments Law
المادة 2 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
This article bars opening any pharmaceutical establishment before obtaining the necessary license from the Saudi Food and Drug Authority in the owner's name.
Official text (Arabic)
This article has not been amended since the law was issued.
لا يسمح بفتح منشأة صيدلية إلا بعد الحصول على الترخيص اللازم من الهيئة باسم مالك المنشأة.
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 2 explained in plain English
This article sets the basic licensing rule: a pharmaceutical establishment may not be opened except after obtaining the necessary license from the Authority, meaning the Saudi Food and Drug Authority.
To understand its scope, refer to the definition of "pharmaceutical establishment" in Article 1, which covers:
- A factory for pharmaceutical and herbal products.
- A warehouse trading in pharmaceutical and herbal products.
- A scientific office.
- A center for drug consultations or product analysis.
The article requires the license to be issued in the name of the establishment's owner, so it is not issued in the name of the manager or anyone else. The license must come before opening, so activity may not begin and a license be requested later.
After this article comes Article 3, which sets the conditions for licensing a drug consultation or product analysis center, including that its manager be a full-time pharmacist licensed to practice the profession, and that the conditions and specifications set by the Regulations be met. The license required here is therefore granted only on meeting the conditions specific to the type of establishment.
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
Khaled wants to open a warehouse to import and distribute medicines in Jeddah. He may not open the warehouse before obtaining the license from the Saudi Food and Drug Authority, and the license is issued in his name as the establishment's owner.
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 2 of the Saudi Pharmaceutical Establishments Law
Can a medicine warehouse be opened before it is licensed?
No. The article bars opening any pharmaceutical establishment except after obtaining the necessary license from the Authority.
In whose name is a pharmaceutical establishment's license issued?
It is issued in the name of the establishment's owner.
Which body issues the pharmaceutical establishment license?
The Saudi Food and Drug Authority.
More articles on Licensing of Pharmaceutical Establishments
- 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.
- 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.