Article 18 of the Saudi Narcotics Law Implementing Regulations
المادة 18 من اللائحة التنفيذية لنظام مكافحة المخدرات والمؤثرات العقلية
The article regulates license applications to establish factories or laboratories producing narcotic or psychotropic substances, and forming a permanent committee to study them and refer approved ones to the Council of Ministers.
Official text (Arabic)
This article has not been amended since the law was issued.
1- تقدم طلبات الترخيص بإنشاء مصانع أو معامل تختص بإنتاج مواد مخدرة أو مؤثرات عقلية، أو فصلها، أو تشييدها لأغراض علمية أو تجارية إلى الهيئة العامة للغذاء والدواء.
2- تشكل في الهيئة العامة للغذاء والدواء لجنة دائمة بمشاركة وزارة الداخلية ووزارة التجارة والصناعة ووزارة الصحة تتولى مباشرة المهمات التالية:
أ - وضع شروط وإجراءات منح تراخيص المصانع والمعامل المشار إليها في الفقرة (1) أعلاه، وكيفية مراقبتها.
ب- دراسة طلبات الترخيص المشار إليها في الفقرة (1) أعلاه، ومدى مناسبة الموافقة عليها.
3 - ترفع الهيئة العامة للغذاء والدواء طلبات الترخيص التي وافقت عليها اللجنة الدائمة إلى مجلس الوزراء لاتخاذ الإجراء اللازم.
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 concerns anyone who wishes to establish a factory or laboratory that produces, separates or builds narcotic or psychotropic substances, for scientific or commercial purposes.
Licensing stages:
- Submitting the application to the Saudi Food and Drug Authority.
- Study by a permanent committee in the Authority, with the participation of the Ministry of Interior, the Ministry of Commerce and Industry and the Ministry of Health. The committee sets the conditions and procedures for granting licenses and how these factories and laboratories are monitored, and studies the applications and whether approving them is appropriate.
- Referral to the Council of Ministers: the Authority refers the applications the committee approved to the Council of Ministers to take the necessary action.
In practical terms, the committee's approval alone is not enough; the final decision on these applications goes through the Council of Ministers. The article does not state the detailed licensing conditions, as these are among the tasks of the permanent committee.
Investors in the pharmaceutical industry who are studying such a project can consult a lawyer specialized in commercial and investment cases.
Practical example
A Saudi pharmaceutical company wants to set up a production line for a medicine containing a narcotic substance. It submits its application to the Saudi Food and Drug Authority, the permanent committee studies it, and if it approves, the application is referred to the Council of Ministers.
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 Narcotics Law Implementing Regulations
Where is an application to license a factory producing narcotic substances submitted?
To the Saudi Food and Drug Authority.
Who sets the licensing conditions for these factories?
A permanent committee in the Authority with the participation of the Ministries of Interior, Commerce and Industry, and Health.
Is the committee's approval final?
No, the Authority refers the approved applications to the Council of Ministers to take the necessary action.
More articles on Storing Narcotics and Keeping Their Records
- Article 15
The article empowers the Chief Executive Officer of the Saudi Food and Drug Authority, in agreement with the Minister of Health, to approve procedures and controls for taking custody of narcotics in warehouses, factories and treatment institutions.
يعتمد الرئيس التنفيذي للهيئة العامة للغذاء والدواء - بالاتفاق مع وزير الصحة - إجراءات وضوابط تسلّم عهدة المواد المخدرة أو المؤثرات العقلية في مستودعات ومصانع ال
- Article 16
The article sets the data that must be included in the register of narcotic and psychotropic substances at licensed establishments, and requires submitting the periodic register every six months.
1- يجب أن يشتمل بيان تسجيل المواد المخدرة أو المؤثرات العقلية في المنشآت الصيدلية والمؤسسات العلاجية أو البحثية المرخص لها باستعمال المواد المخدرة أو المؤثرات ا
- Article 17
The article empowers the Chief Executive Officer of the Saudi Food and Drug Authority, in coordination with the Minister of Health, to approve procedures and controls for selling, delivering and disposing of narcotics in pharmacies and treatment institutions.
يعتمد الرئيس التنفيذي للهيئة العامة للغذاء والدواء - بالتنسيق مع وزير الصحة - إجراءات وضوابط بيع وتسليم المواد المخدرة أو المؤثرات العقلية والتصرف فيها في المنش
- Article 19
The article sets the conditions for storing narcotic and psychotropic substances at licensed establishments, and the procedures required when quantities are in excess, lost, short or damaged.
1- شروط حفظ المواد المخدرة والمؤثرات العقلية في المنشآت المرخص لها: أ - أن تحفظ وفقا لمواصفات وشروط التخزين التي قررتها الشركة الصانعة. ب - أن يكون الحفظ في خزن
- Article 22
The article requires a special register for each medicine containing a narcotic or psychotropic substance at pharmacy establishments, and sets its data, how it is written and signed, and its retention for ten years then destruction.
1- يجب أن يكون هناك سجل خاص في المنشآت الصيدلية لكل دواء يحتوي على مادة مخدرة أو مؤثر عقلي . 2 - يجب أن تكون صفحات السجل مرقمة تسلسليًّا . 3- يجب أن يشتمل السجل
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.