Article 23 of the Saudi Pharmaceutical Establishments Law
المادة 23 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
This article lets the Authority, when necessary, allow the import of pharmaceutical and herbal products that are not prohibited before they are registered.
Official text (Arabic)
This article has not been amended since the law was issued.
يجوز للهيئة - عند الضرورة - السماح باستيراد المستحضرات الصيدلانية والعشبية غير المحظورة قبل تسجيلها.
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 23 explained in plain English
This article addresses a special case in which products may be imported before they are registered. The Authority may allow the import of pharmaceutical and herbal products before registration, on two conditions:
- Necessity: this must be when necessary.
- No prohibition: the products must be not prohibited.
The rule is discretionary: permission is a power of the Authority, which it assesses, and not an automatic right of the importer. The article does not define "necessity" or state its controls, and does not specify which products are prohibited.
This exception has practical importance: in some cases the market may need a product whose registration has not yet been completed, and the text lets the Authority deal with that.
It is preceded by Article 22, which bars export except after the Authority's approval, and followed by Article 24, which allows the President to cancel the registration of a factory or product and stop its circulation on the recommendation of the competent registration committee.
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
Hospitals have an urgent need for a medicine that is not prohibited but not yet registered in the Kingdom. For this necessity, the Saudi Food and Drug Authority may allow it to be imported before it is registered.
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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Dr. Ali Al-Rubaie Law Office and Ittihad Al-Asr Legal Company
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Frequently asked questions about Article 23 of the Saudi Pharmaceutical Establishments Law
Can a drug not registered in Saudi Arabia be imported?
It can if the Authority allows it when necessary and the product is not prohibited.
Is permission to import a right of the importer?
No. The text makes it discretionary for the Authority, when necessary.
Does the exception cover prohibited products?
No. The text limits it to products that are not prohibited.
More articles on Import and Export of Pharmaceutical Preparations
- Article 22
This article bars exporting pharmaceutical and herbal products except after the approval of the Saudi Food and Drug Authority.
لا يجوز تصدير المستحضرات الصيدلانية والعشبية إلا بعد موافقة الهيئة.
- Article 25
This article lets the Authority allow non-prohibited pharmaceutical and herbal products to be brought in for personal use, with a medical report and in limited quantities.
للهيئة السماح بدخول المستحضرات الصيدلانية والعشبية غير المحظورة للاستعمال الشخصي بموجب تقرير طبي وبكميات محدودة.
- Article 27
This article lets trading warehouses import registered products that the producing factory does not supply, provided the Authority approves.
لمستودعات الاتجار بالمستحضرات الصيدلانية والعشبية استيراد المستحضرات الصيدلانية والعشبية المسجلة إذا لم يوفرها المصنع المنتج، بشرط موافقة الهيئة.
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.

