Article 17 of the Saudi Pharmaceutical Establishments Law
المادة 17 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
This article bars circulating pharmaceutical and herbal products before they are registered with the Saudi Food and Drug Authority.
Official text (Arabic)
This article has not been amended since the law was issued.
يحظر تداول المستحضرات الصيدلانية والعشبية قبل تسجيلها لدى الهيئة.
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 17 explained in plain English
This article sets a fundamental rule: circulating pharmaceutical and herbal products before they are registered with the Authority is prohibited.
Registration here concerns the product itself, which is different from licensing the establishment. It is not enough for the pharmacy or warehouse to be licensed; every product in circulation must be registered with the Authority.
The prohibition covers:
- Pharmaceutical products (medicines).
- Herbal products, which under Article 1 are plants or herbs with a medical claim prepared in pharmaceutical form.
The text uses the word "circulation" without limiting it to sale, and does not define it.
Several articles link to it:
- Article 16: requires anyone who dispensed or sold an unregistered product to notify the Authority and refund the price.
- Article 18: sets the registration term and fee.
Registration is therefore a precondition to any circulation, and its expiry without renewal returns the product to the status of an unregistered one.
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 start-up in Jeddah offered stores an herbal product marketed as treating insomnia, without registering it with the Authority. This circulation is prohibited because the product has not yet been registered.
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 17 of the Saudi Pharmaceutical Establishments Law
Can a drug not registered with the Food and Drug Authority be sold?
No. The article bars circulating pharmaceutical and herbal products before they are registered with the Authority.
Does registration cover herbal products?
Yes. The prohibition covers pharmaceutical and herbal products together.
Does a pharmacy's license replace registering the drug?
No. Registering the product is a separate condition from licensing the establishment.
More articles on Registration of Pharmaceutical and Herbal Preparations
- Article 18
This article sets the registration term for a pharmaceutical or herbal product at five years, renewable, with a fee of SAR 1,000 for each strength, pharmaceutical form or package.
مدة تسجيل كل مستحضر صيدلاني أو عشبي خمس سنوات قابلة للتجديد، ويستوفى لذلك رسم قدره (ألف) ريال لكل تركيز أو صيغة دوائية أو عبوة، وذلك عند التسجيل أو التجديد.
- Article 20
This article provides for committees formed by the President's decision to register product factories and their products, and refers registration conditions and committee work to the Regulations and members' remuneration to the Board.
تكوَّن - بقرار من الرئيس - لجان لتسجيل مصانع المستحضرات الصيدلانية والعشبية ومنتجاتها. وتحدد اللائحة شروط التسجيل وكيفية تكوين هذه اللجان وطريقة عملها. وتحدد مك
- Article 24
This article lets the President cancel the registration of any factory or product and stop its circulation on the registration committee's recommendation, and lets the Authority approve re-exporting or destroying it.
للرئيس إصدار قرار بإلغاء تسجيل أيٍّ من مصانع المستحضرات الصيدلانية والعشبية، وأي مستحضر صيدلاني أو عشبي وإيقاف تداوله، وذلك بناءً على توصيةٍ من لجنة التسجيل الم
- Article 28
This article bars a pharmaceutical and herbal products factory from starting commercial-quantity production of products before they are registered.
لا يجوز لمصنع المستحضرات الصيدلانية والعشبية أن يبدأ إنتاج المستحضرات الصيدلانية والعشبية بكميات تجارية إلا بعد تسجيلها.
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.