Article 19 of the Saudi Pharmaceutical Establishments Law
المادة 19 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
This article bars selling registered pharmaceutical and herbal products except after the Authority prices them and in the packages it specifies.
Official text (Arabic)
This article has not been amended since the law was issued.
لا يجوز بيع المستحضرات الصيدلانية والعشبية المسجلة إلا بعد تسعيرها من الهيئة، ووفقاً للعبوات التي تحددها.
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 19 explained in plain English
This article adds two conditions for sale after registration:
- Pricing: a registered product may not be sold except after the Authority has priced it.
- Packages: sale is made in the packages the Authority specifies.
A product's path to the market therefore goes through three consecutive steps:
- Registration with the Authority, for the term and fee in Article 18 (five years, renewable, and SAR 1,000 for each strength, form or package).
- Pricing by the Authority.
- Sale in the packages the Authority specifies.
Registration alone is therefore not enough for sale, and an establishment may not set a price of its own for a product the Authority has not yet priced. The second condition means that sale must be in the approved package, and the text mentions no exception for selling part of a package.
This article comes before Article 20, which regulates forming the committees for registering factories and their products.
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 company obtained registration of a new product with the Authority and wants to put it in pharmacies immediately. It may not be sold before the Authority prices it, and it must be sold in the packages the Authority specifies.
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 19 of the Saudi Pharmaceutical Establishments Law
Can a drug be sold right after it is registered?
No. The Authority must also price it before it is sold.
Who determines the packages in which a drug is sold?
The Saudi Food and Drug Authority, and sale is according to the packages it specifies.
Does the rule cover herbal products?
Yes. The text covers registered pharmaceutical and herbal products.
More articles on Drug Pricing and Profit Margins
- Article 11
This article bases the price of a pharmaceutical or herbal product on the factory price or the export price to the Kingdom, and requires the Authority to review prices periodically.
يحسب سعر المستحضر الصيدلاني أو العشبي بناءً على سعر المصنع أو سعر التصدير إلى المملكة بعملة بلد المنشأ أو العملة التي تقررها الهيئة. وتقوم الهيئة بمراجعة أسعار
- Article 12
This article sets the profit percentages for a trading warehouse, a pharmacy and an herbal products sales establishment on a product's price, according to factory or export price brackets.
تحسب نسبة ربح على سعر المستحضر الصيدلاني أو العشبي لكل مستودع اتجار بالمستحضرات الصيدلانية والعشبية، وصيدلية، ومنشأة بيع المستحضرات العشبية، على النحو الآتي: سع
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.