Article 16 of the Saudi Narcotics Law Implementing Regulations
المادة 16 من اللائحة التنفيذية لنظام مكافحة المخدرات والمؤثرات العقلية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 العقلية على الآتي:
أ - رقم السجل الدوري (المدور) وتاريخه .
ب- الاسم العلمي للمادة المخدرة (أو المؤثر العقلي) وشكلها الصيدلاني وتركيزها وحجمها وعبوتها .
ج - الكمية الباقية من السجل الدوري السابق .
د - الكمية الواردة .
هـ - جهة الورود .
و - المجموع الكلي .
ز - الكمية المصروفة .
ح - البيانات الخاصة بمن صرفت له الكمية .
ط - الكمية الباقية .
ي - اسم مسؤول عهدة المواد المخدرة أو المؤثرات العقلية وتوقيعه .
ك - اسم مدير المنشأة أو من يفوضه وتوقيعه .
ل - الختم الرسمي للمنشأة .
2 - تقدم بيانات السجل الدوري (المدور) كل ستة أشهر إلى وزارة الصحة أو الهيئة العامة للغذاء والدواء كل بحسب اختصاصه، وتحفظ صورة منها لدى المنشأة.
3 - يعتمد الرئيس التنفيذي للهيئة العامة للغذاء والدواء - بالاتفاق مع وزير الصحة - إجراءات مراقبة الصرف وضوابطها.
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 16 explained in plain English
This article requires pharmacy establishments and treatment or research institutions licensed to use narcotic or psychotropic substances to keep a periodic (carried-forward) register containing specific data, namely:
- The number and date of the periodic register.
- The scientific name of the substance, its pharmaceutical form, concentration, volume and packaging.
- The quantity remaining from the previous register, the quantity received and its source, and the total.
- The quantity dispensed and the details of the person to whom it was dispensed, and the quantity remaining.
- The name and signature of the person responsible for custody, the name and signature of the establishment's manager or his delegate, and the official seal.
Periodic submission: the register's data is submitted every six months to the Ministry of Health or the Saudi Food and Drug Authority, according to jurisdiction, and the establishment keeps a copy.
Monitoring dispensing: the Chief Executive Officer of the Authority, in agreement with the Minister of Health, approves the procedures and controls for monitoring dispensing; the article does not state their details.
The practical purpose is that every tablet or ampoule can be traced from the moment it is received until it is dispensed. Establishments that need to review their obligations can consult a lawyer specialized in commercial cases.
Practical example
A hospital pharmacy in Riyadh receives 50 ampoules and dispenses 20 to specific patients; it records in the periodic register the quantity received and its source, the amount dispensed and the patients' details, and the remainder, the person responsible for custody and the manager sign, and the data is then submitted after six months.
Translated from our Arabic explanation with machine assistance. For guidance only; it does not replace advice from a lawyer on your situation.
How we write and review contentCommercial & Corporate Law lawyers: ask a specialist about your case
Describe your situation briefly and we'll suggest a lawyer who specialises in this law
Commercial & Corporate Law lawyers
Lawyers who handle this kind of case
Ibrahim Al Salem Law Firm
Active contributor
Dr. Ali Al-Rubaie Law Office and Ittihad Al-Asr Legal Company
Frequently asked questions about Article 16 of the Saudi Narcotics Law Implementing Regulations
How often is the narcotics periodic register submitted?
Every six months to the Ministry of Health or the Saudi Food and Drug Authority, according to jurisdiction, with a copy kept at the establishment.
Who signs the narcotics register?
The person responsible for custody of the substances and the establishment's manager or his delegate, with the establishment's official seal.
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 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 18
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.
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
- 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.