Article 36 of the Saudi Pharmaceutical Establishments Law
المادة 36 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
The article lets the Authority impose fines below SAR 100,000 on scientific offices and centers, below SAR 200,000 on warehouses and below SAR 300,000 on factories, under a schedule issued by the Board.
Official text (Arabic)
This article has not been amended since the law was issued.
تتولى الهيئة توقيع عقوبة الغرامة فيما دون (100.000) مائة ألف ريال في حق المكاتب العلمية، ومراكز الاستشارات الدوائية أو تحليل المستحضرات الصيدلانية المخالفة، وفيما دون (200.000) مائتي ألف ريال في حق مستودعات الاتجار بالمستحضرات الصيدلانية والعشبية المخالفة، وفيما دون (300.000) ثلاثمائة ألف ريال في حق مصانع المستحضرات الصيدلانية والعشبية المخالفة، وذلك وفقاً لجدول يصدره المجلس يتضمن تصنيفاً للمخالفات، والعقوبات المحددة لكل منها. وتعتمد هذه العقوبات بقرار من الرئيس أو من فوضه. وفي جميع الأحوال، يكون للهيئة عند الضرورة اتخاذ ما تراه من تدابير احترازية.
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 36 explained in plain English
This article gives the Authority power to impose a fine directly, within limits that differ depending on the type of violating establishment:
- Scientific offices and pharmaceutical consultation or product analysis centers: below SAR 100,000.
- Trading warehouses: below SAR 200,000.
- Product factories: below SAR 300,000.
The wording 'below' means that the Authority's power stops short of these amounts.
Controls:
- The fine is imposed under a schedule issued by the Board (the Authority's board of directors), which includes a classification of violations and the specific penalty for each.
- Penalties are approved by decision of the CEO or the person to whom the CEO delegates.
Precautionary measures: in all cases, the Authority may, when necessary, take the precautionary measures it considers appropriate. The text does not specify these measures.
This article follows Article 35, which sets the upper limits of penalties, including a fine of up to SAR 5 million. Article 37 indicates that grievances against penalty decisions issued under this article are heard by the committee formed by decision of the Board.
To understand how this provision applies to a particular case, it is advisable to consult a lawyer specialized in health and pharmaceutical regulations.
Practical example
The scientific office of a pharmaceutical company in Riyadh committed a violation classified in the schedule of violations. The Authority may impose a fine below SAR 100,000 under the schedule, approved by the CEO or the person the CEO delegates.
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 36 of the Saudi Pharmaceutical Establishments Law
How large a fine can the Saudi Food and Drug Authority impose on a medicine warehouse?
The Authority may impose a fine below SAR 200,000 on violating trading warehouses, under a schedule issued by the Board.
How large a fine can the Authority impose on a pharmaceutical factory?
Below SAR 300,000.
Who approves the Authority's fines?
The Authority's CEO or the person to whom the CEO delegates.
Can a fine imposed by the Authority be challenged?
Article 37 provides that the committee formed by decision of the Board hears grievances submitted to the Authority against penalty decisions issued under this article.
More articles on Penalties for Drug and Herbal Violations
- Article 34
The article lists the acts that violate the law, including adulterating products, selling or importing adulterated, spoiled or unregistered products, false promotion and counterfeit packaging.
يعد مخالفاً لأحكام النظام كل مَن: 1- غش أو شرع في غش أي مستحضر صيدلاني أو عشبي. 2- باع، أو صرف، أو حاز بقصد الاتجار مستحضراً صيدلانيًّا أو عشبيًّا مغشوشاً، أو ف
- Article 35
The article sets penalties of a fine up to SAR 5 million, closure up to 180 days or license cancellation, rising to prison up to 10 years or a fine up to SAR 10 million for adulteration offenses.
1- مع عدم الإخلال بأي عقوبة أشد ينص عليها نظام آخر، يعاقب مرتكب أيٍّ من الأفعال المنصوص عليها في المادة (الرابعة والثلاثين) من النظام بواحدة أو أكثر من العقوبات
- Article 39
The article allows the judgment or decision imposing a penalty to include publishing its operative part at the violator's expense in a local newspaper or other suitable means, once it is final or unchallengeable.
يجوز تضمين الحكم أو القرار الصادر بالعقوبة - بحسب الأحوال - النص على نشر منطوقه على نفقة المخالف في صحيفة محلية تصدر في مقر إقامته، فإن لم تكن في مقره صحيفة ففي
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.