Article 24 of the Saudi Pharmaceutical Establishments Law
المادة 24 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 المختصة، ويجوز للهيئة الموافقة على إعادة تصديره أو إتلافه.
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 24 explained in plain English
This article regulates cancelling registration, and contains these elements:
- Who decides: the President, meaning the Authority's Chief Executive Officer.
- What the decision covers: cancelling the registration of any pharmaceutical and herbal products factory, or any pharmaceutical or herbal product, and stopping its circulation.
- The basis: the decision must be on the recommendation of the competent registration committee.
- The fate of the product: the Authority may approve re-exporting it or destroying it.
The President therefore does not issue a cancellation decision in the first instance without a recommendation from the competent committee. The article does not state the grounds for cancellation, so no particular ground can be inferred from the text.
Cancellation is coupled with stopping the product's circulation. The article lets the Authority approve one of two ways to dispose of it: re-exporting it or destroying it. The text does not say who bears the cost of this. It is preceded by Article 23, which allows the Authority, when necessary, to permit importing non-prohibited products before they are registered.
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
The competent registration committee recommended cancelling the registration of an herbal product, so the Authority's Chief Executive Officer issued a decision cancelling its registration and stopping its circulation. The Authority may then approve re-exporting the existing quantities or destroying them.
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 24 of the Saudi Pharmaceutical Establishments Law
Who has the power to cancel a drug's registration?
The Authority's Chief Executive Officer, on the recommendation of the competent registration committee.
Can the registration of a drug factory be cancelled?
Yes. The text allows the President to cancel the registration of any pharmaceutical and herbal products factory.
What happens to a drug after its registration is cancelled?
Its circulation is stopped, and the Authority may approve re-exporting it or destroying it.
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 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 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.