Article 18 of the Saudi Pharmaceutical Establishments Law
المادة 18 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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.
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 18 explained in plain English
This article regulates the term and fee for registering a product:
- Term: five years, renewable.
- Fee: SAR 1,000.
- Unit for calculating the fee: each strength, pharmaceutical form or package.
- When it is charged: on registration and on renewal.
The practical effect of the calculation unit is that the fee is not paid once for a medicine in general, but multiplies with the number of its strengths, forms or packages. The text does not detail how to calculate if a product differs in more than one element at the same time.
This article links to Article 17, which bars circulating products before they are registered, so registration and its renewal on time are a condition for continuing circulation. It is followed by Article 19, which bars selling registered products except after the Authority has priced them and in the packages it specifies.
Note that this fee is specific to registering the product; it concerns the product, not the establishment that makes or sells it.
Practical example
A company registered a medicine in two different strengths, 250 mg and 500 mg. A fee of SAR 1,000 is charged for each strength, and the registration lasts five years, renewable for a similar fee.
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 18 of the Saudi Pharmaceutical Establishments Law
How long does a drug registration last in Saudi Arabia?
Five years, renewable.
What is the fee for registering a drug?
SAR 1,000 for each strength, pharmaceutical form or package, on registration or renewal.
Is the fee paid once for each drug?
No. The fee is calculated for each strength, pharmaceutical form or package.
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 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.