Article 22 of the Saudi Pharmaceutical Establishments Law
المادة 22 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
This article bars exporting pharmaceutical and herbal products except after the approval of the Saudi Food and Drug Authority.
Official text (Arabic)
This article has not been amended since the law was issued.
لا يجوز تصدير المستحضرات الصيدلانية والعشبية إلا بعد موافقة الهيئة.
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 22 explained in plain English
This article subjects the export of pharmaceutical and herbal products to prior control: export is not permitted except after the Authority's approval.
The key points of the rule:
- The approval is prior: it must be obtained before exporting, not after.
- It covers both kinds: pharmaceutical products and herbal products.
- It is general as to the exporter: the text does not limit the rule to factories or warehouses, so it covers anyone who exports.
The article does not set the conditions or criteria for approval or the procedures for requesting it.
The meaning of this rule is understood in light of Article 21, which requires registered factories and the warehouses representing them to supply their registered products on the market; control over export lets the Authority follow what leaves in the way of products. It is followed by Article 23, which addresses the opposite side, import, by allowing the Authority, when necessary, to permit importing products that are not prohibited before they are registered.
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 medicine warehouse in Dammam received a request from a distributor in a neighboring country to buy a quantity of a product. It may not export the shipment before obtaining the approval of the Saudi Food and Drug Authority.
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 22 of the Saudi Pharmaceutical Establishments Law
Can drugs be exported from Saudi Arabia?
Yes, after obtaining the approval of the Saudi Food and Drug Authority.
Does the rule cover herbal products?
Yes. The text covers pharmaceutical and herbal products.
Did the article set the conditions for export approval?
No. The article requires approval without detailing its conditions.
More articles on Import and Export of Pharmaceutical Preparations
- Article 23
This article lets the Authority, when necessary, allow the import of pharmaceutical and herbal products that are not prohibited before they are registered.
يجوز للهيئة - عند الضرورة - السماح باستيراد المستحضرات الصيدلانية والعشبية غير المحظورة قبل تسجيلها.
- 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.