Article 20 of the Saudi Pharmaceutical Establishments Law
المادة 20 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
تكوَّن - بقرار من الرئيس - لجان لتسجيل مصانع المستحضرات الصيدلانية والعشبية ومنتجاتها. وتحدد اللائحة شروط التسجيل وكيفية تكوين هذه اللجان وطريقة عملها. وتحدد مكافأة أعضاء هذه اللجان بقرار من المجلس.
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 20 explained in plain English
This article regulates the body that handles registering pharmaceutical and herbal product factories and their products:
- Forming committees: committees are formed for this purpose by decision of the President, meaning the Chief Executive Officer of the Authority.
- What is referred to the Regulations: the Implementing Regulations set the registration conditions, how the committees are formed and how they work.
- Remuneration: the committee members' remuneration is set by decision of the Board, meaning the Authority's Board of Directors.
Note that registration covers two things: the factories themselves and their products. The Law does not state the detailed registration conditions but leaves them to the Regulations, which anyone wanting to know them should consult. The text also separates two powers: forming the committees belongs to the Chief Executive Officer, and setting their members' remuneration belongs to the Authority's Board of Directors.
It is preceded by Article 19, which bars selling registered products except after the Authority prices them and in the packages it specifies, and followed by Article 21, which requires registered factories and the warehouses representing them to supply their registered products.
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 20 of the Saudi Pharmaceutical Establishments Law
Who registers drugs and their factories in Saudi Arabia?
Committees formed by decision of the Chief Executive Officer of the Saudi Food and Drug Authority.
Where do I find the conditions for registering a drug factory?
The article refers the registration conditions to the Law's Implementing Regulations.
Who sets the remuneration of the registration committee members?
The Authority's Board of Directors, by its decision.
More articles on Registration of Pharmaceutical and Herbal Preparations
- Article 17
This article bars circulating pharmaceutical and herbal products before they are registered with the Saudi Food and Drug Authority.
يحظر تداول المستحضرات الصيدلانية والعشبية قبل تسجيلها لدى الهيئة.
- 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 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.

