Article 16 of the Saudi Pharmaceutical Establishments Law
المادة 16 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 تم صرفه أو بيعه وكميته، واسم من صُرف أو بيع له المستحضر وعنوانه، كما يلتزم بإعادة الثمن للمشتري.
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 16 explained in plain English
This article places obligations on anyone who dispensed or sold a pharmaceutical or herbal product that is one of the following:
- Adulterated.
- Spoiled.
- Expired.
- Unregistered.
Adulterated and spoiled are defined in Article 1: adulterated means a product whose content, identity or source has been deliberately altered with intent to deceive, or that is contaminated, has wrong or ineffective ingredients, or is in counterfeit packaging; and spoiled means a product whose properties have changed so that it is unfit for use.
The obligations:
- Notifying the Authority as soon as they learn of the information relating to what they dispensed or sold, its quantity, and the name and address of the person to whom the product was dispensed or sold.
- Refunding the price to the buyer.
The obligation starts from the moment of knowledge, and the text does not tie it to a complaint from the buyer. It covers anyone who dispensed or sold, so it is not limited to pharmacies. The practical aim is to enable the Authority to trace the product and reach those who obtained it.
It links to Article 17, which bars circulating products before they are registered, and Article 15 on replacing products close to expiry.
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 pharmacy in Riyadh discovered that it sold a customer a box of expired medicine. As soon as it learns of it, it must notify the Saudi Food and Drug Authority of the quantity sold and the buyer's name and address, and refund the price to him.
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 16 of the Saudi Pharmaceutical Establishments Law
What should a pharmacy do if it sold an expired medicine?
It must notify the Authority as soon as it learns of what was sold, its quantity and the buyer's name and address, and refund the price to the buyer.
Can I get a refund for an adulterated or spoiled medicine?
The article requires anyone who dispensed or sold an adulterated, spoiled, expired or unregistered product to refund the price to the buyer.
When must the Authority be notified?
As soon as they learn that the product dispensed or sold is adulterated, spoiled, expired or unregistered.
More articles on Adulterated and Spoiled Drugs
- 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 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.