Article 34 of the Saudi Pharmaceutical Establishments Law
المادة 34 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 فاسداً، أو منتهي الصلاحية، أو غير مسجل.
3- صنع أو ركب مستحضراً صيدلانيًّا أو عشبيًّا بالمخالفة لشروط التسجيل، أو أي حكم من أحكام النظام ولائحته.
4- أدخل إلى المملكة مستحضراً صيدلانيًّا أو عشبيًّا غير مسجل، أو مغشوشاً، أو فاسداً، أو منتهي الصلاحية، أو حاول إدخال أيٍّ من ذلك.
5- استعمل للترويج للمستحضر الصيدلاني أو العشبي معلومات غير حقيقية، سواء على المستحضر، أو في الدعاية له، أو بالمخالفة لشروط التسجيل.
6- نقل أو خزن مستحضراً صيدلانيًّا أو عشبيًّا بالمخالفة لشروط النقل والتخزين التي تحددها الهيئة.
7- أدخل إلى المملكة عبوات أو أغلفة لمستحضر صيدلاني أو عشبي بقصد الغش، أو حاول إدخال أي من ذلك.
8- صنع أو طبع أو حاز أو باع أو عرض عبوات أو أغلفة لمستحضر صيدلاني أو عشبي بقصد الغش.
9- ارتكب أي مخالفة أخرى لأحكام النظام.
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 34 explained in plain English
This article defines who counts as violating the provisions of the law: anyone who commits one of the following acts:
- Adulterated any pharmaceutical or herbal product, or attempted to adulterate it.
- Sold, dispensed or possessed for trade a product that is adulterated, spoiled, expired or unregistered.
- Manufactured or compounded a product in breach of the registration conditions or of any provision of the law and its regulations.
- Brought into the Kingdom a product that is unregistered, adulterated, spoiled or expired, or attempted to do so.
- Used untrue information for promotion, on the product or in advertising for it, or in breach of the registration conditions.
- Transported or stored a product in breach of the transport and storage conditions set by the Authority.
- Brought containers or wrappers for a product into the Kingdom with intent to defraud, or attempted to do so.
- Made, printed, possessed, sold or displayed containers or wrappers for a product with intent to defraud.
- Committed any other violation of the provisions of the law.
Note that for some acts an attempt is enough (items 1, 4 and 7), that possession in item 2 is limited to intent to trade, and that items 7 and 8 are limited to intent to defraud. Adulterated and spoiled are defined in Article 1.
The penalties are in Article 35; it punishes these acts with a fine, closure or license cancellation, and increases the penalty to imprisonment or a higher fine for items (1), (2), (4), (7) and (8).
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
A person in Riyadh was caught storing quantities of an expired medicine with the intent to sell it. This act falls under paragraph (2) of the article, because it is possession for trade of an expired product.
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 34 of the Saudi Pharmaceutical Establishments Law
Is possessing an adulterated medicine a violation?
It is a violation if the possession is with intent to trade, and so is selling or dispensing it.
Is attempting to bring an unregistered medicine into the Kingdom a violation?
Yes. Paragraph (4) treats bringing in an unregistered, adulterated, spoiled or expired product, or attempting to bring it in, as a violation.
Is false advertising of a herbal product a violation?
Yes. Using untrue information to promote the product, on it or in advertising for it, is a violation under paragraph (5).
What is the penalty for these violations?
Article 35 sets the penalties and increases them for the acts in paragraphs (1), (2), (4), (7) and (8).
More articles on Adulterated and Spoiled Drugs
- Article 16
This article requires anyone who dispensed or sold an adulterated, spoiled, expired or unregistered product to notify the Authority as soon as they learn of it and to refund the buyer's price.
على كل من صرف أو باع مستحضراً صيدلانيًّا أو عشبيًّا مغشوشاً، أو فاسداً، أو منتهي الصلاحية، أو غير مسجل، إبلاغ الهيئة - فور علمه بذلك - بالمعلومات التي تتعلق بما
- Article 38
The article requires violations covered by paragraph (2) of Article 35 to be referred to the Public Prosecution for investigation and then to the competent court.
إذا كانت المخالفة مشمولة بحكم الفقرة (2) من المادة (الخامسة والثلاثين) من النظام، فتحال إلى النيابة العامة؛ للتحقيق فيها، وإحالتها إلى المحكمة المختصة وفقاً للإ
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.