Article 15 of the Saudi Pharmaceutical Establishments Law
المادة 15 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
This article bars a pharmaceutical establishment from holding products without documents proving their source and quantities, and requires manufacturers and warehouses to replace products with only one month of shelf life left.
Official text (Arabic)
This article has not been amended since the law was issued.
1- يحظر على المنشأة الصيدلية حيازة أي كمية من المستحضرات الصيدلانية والعشبية دون وجود مستندات تثبت مصدر شرائها وكمياتها.
2- يلتزم مصنع المستحضرات الصيدلانية والعشبية باستبدال أي كمية من المستحضرات التي باعها على مستودع الاتجار بالمستحضرات الصيدلانية والعشبية؛ إذا لم يبق على صلاحيتها إلا شهر واحد فقط، ويقع الالتزام نفسه على عاتق المستودع في مواجهة الصيدلية.
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 15 explained in plain English
This article contains two separate provisions:
First: proof of source. A pharmaceutical establishment is barred from holding any quantity of pharmaceutical and herbal products without documents proving the source of purchase and the quantities. It is not enough for the product to be sound; the establishment must prove where it bought it and how much it bought. Under Article 1, a pharmaceutical establishment is the factory, warehouse, scientific office, and consultation or analysis center.
Second: replacing products close to expiry.
- The factory must replace any quantity it sold to a trading warehouse if only one month of its shelf life remains.
- The same obligation falls on the warehouse toward the pharmacy.
The chain is therefore continuous: the pharmacy claims against the warehouse, and the warehouse claims against the factory. The text does not mention the herbal products sales establishment among those entitled to replacement, and does not set replacement procedures.
This article links to Article 16, which requires anyone who dispensed or sold an expired, spoiled, adulterated or unregistered product to notify the Authority and refund the price.
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 pharmacist at a pharmacy in Abha noticed that a quantity of a medicine bought from a warehouse has only one month left before it expires. The warehouse must replace this quantity for the pharmacy, and the warehouse may in turn ask the factory to replace what it sold it on the same condition.
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 15 of the Saudi Pharmaceutical Establishments Law
Must a warehouse replace medicines close to expiry?
Yes. The warehouse must replace products for the pharmacy if only one month of shelf life remains, and likewise the factory toward the warehouse.
Can a pharmaceutical establishment hold medicines without invoices?
No. It is barred from holding any quantity without documents proving the source of purchase and the quantities.
When can replacement be requested?
If only one month of the product's shelf life remains.
More articles on Sale and Circulation of Drugs and Herbs
- Article 13
This article bars selling samples of pharmaceutical and herbal products prepared to introduce the product.
لا يجوز بيع عينات المستحضرات الصيدلانية والعشبية المعدة للتعريف بالمنتج.
- Article 14
This article limits retail sale of pharmaceutical products to pharmacies, and herbal products to pharmacies and herbal establishments, except what the President decides may be sold elsewhere.
1- يقصر بيع المستحضرات الصيدلانية بالتجزئة على الصيدليات، ويستثنى من ذلك ما يقرر الرئيس جواز بيعه في غيرها. 2- يقصر بيع المستحضرات العشبية بالتجزئة على الصيدليا
- Article 19
This article bars selling registered pharmaceutical and herbal products except after the Authority prices them and in the packages it specifies.
لا يجوز بيع المستحضرات الصيدلانية والعشبية المسجلة إلا بعد تسعيرها من الهيئة، ووفقاً للعبوات التي تحددها.
- Article 21
This article requires registered product factories in the Kingdom and the warehouses representing them to supply their registered products, however low their price or consumption.
تلتزم مصانع المستحضرات الصيدلانية والعشبية المسجلة في المملكة ومستودعات الاتجار بالمستحضرات الصيدلانية والعشبية الممثلة لها بتوفير مستحضراتها الصيدلانية والعشبي
- Article 26
This article bars trading warehouses from selling products to anyone other than a pharmacy, an herbal products sales establishment and a licensed health establishment, subject to the Article 14 exception.
مع مراعاة الاستثناء الوارد في المادة (الرابعة عشرة) من النظام، يحظر على مستودعات الاتجار بالمستحضرات الصيدلانية والعشبية بيع المستحضرات الصيدلانية والعشبية لغير
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.