Article 33 of the Saudi Pharmaceutical Establishments Law
المادة 33 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
The article gives the Authority power to inspect establishments and products through inspectors named by the CEO, who may seize violating products, hold them, take samples and recommend destruction at the violator's expense.
Official text (Arabic)
This article has not been amended since the law was issued.
تتولى الهيئة التفتيش على المنشآت الصيدلية وعلى المستحضرات الصيدلانية والعشبية؛ للتأكد من تطبيق أحكام النظام ولائحته، وذلك من خلال المفتشين الصادر بتسميتهم قرار من الرئيس، ويكون لهم - في حدود ما تقرره اللائحة - ما يأتي:
1- ضبط المستحضرات الصيدلانية والعشبية المخالفة لأحكام النظام.
2- التعامل مع المضبوطات المخالفة، وذلك وفقاً لما يأتي:
أ- التحفظ عليها وعلى المستندات المتعلقة بها، عند الاقتضاء.
ب- أخذ العينات للتحليل.
ج- التوصية بإتلاف ما يثبت فساده، أو غشه، أو انتهاء صلاحيته، أو ضرره صحيًّا، إذا كان مسجلاً.
د- التوصية بإتلاف المضبوطات غير المسجلة.
ويكون الإتلاف بعد صدور قرار به من الهيئة، وذلك وفقاً للأصول الفنية المتعارف عليها، وتتولى تنفيذه لجنة - أو أكثر - تكوّن لهذا الغرض بقرار من الرئيس. ويتحمل المخالف تكاليف عملية الإتلاف.
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 33 explained in plain English
This article regulates the inspection carried out by the Authority of pharmaceutical establishments and of pharmaceutical and herbal products, to make sure the law and its regulations are applied.
Who inspects? Inspectors named by a decision of the CEO.
Their powers, which apply within the limits set by the regulations:
- Seizing products that violate the provisions of the law.
- Dealing with the seized items:
- Holding them, and their related documents, where needed.
- Taking samples for analysis.
- Recommending destruction of anything proven spoiled, adulterated, expired or harmful to health, if it is registered.
- Recommending destruction of seized items that are not registered.
Destruction: it does not happen on the inspector's recommendation alone, but only after the Authority issues a decision for it, in line with recognized technical standards, and it is carried out by one or more committees formed by decision of the CEO. The violator bears the costs of destruction.
Note that a registered product is not recommended for destruction unless it is proven spoiled, adulterated, expired or harmful, whereas for an unregistered product destruction may be recommended without this condition. It is followed by Article 34, which lists the acts counted as violations of the law.
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
An inspector from the Authority visited a medicine warehouse in Jeddah and found a quantity of an unregistered product. The inspector may seize it, hold it and its documents, take samples, and recommend its destruction. If the Authority issues a decision for destruction, the competent committee carries it out and the warehouse bears the costs.
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 33 of the Saudi Pharmaceutical Establishments Law
Who inspects pharmaceutical establishments in Saudi Arabia?
Inspectors of the Saudi Food and Drug Authority who are named by a decision of the CEO.
Can an inspector destroy seized medicines on their own?
No. The inspector recommends destruction, and destruction takes place only after the Authority issues a decision, carried out by a committee formed by decision of the CEO.
Who pays for destroying violating medicines?
The violator bears the costs of the destruction process.
When is destruction of a registered medicine recommended?
When it is proven spoiled, adulterated, expired or harmful to health.
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.