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Article 22 of the Saudi Narcotics Law Implementing Regulations

المادة 22 من اللائحة التنفيذية لنظام مكافحة المخدرات والمؤثرات العقلية

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.

Official text (Arabic)

This article has not been amended since the law was issued.

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 في الصيدليات والمستودعات على البيانات الآتية:

أ - اسم الدواء العلمي وشكله الصيدلاني وتركيزه وحجمه.

ب- الرصيد السابق .

ج - الكمية الواردة ورقم التشغيل وتاريخ الصلاحية .

د - الجهة الوارد منها وتاريخ الورود .

هـ - المجموع الكلي .

و - الكمية المصروفة ورقم التشغيل وتاريخ الصرف واسم من صرفها وتوقيعه .

ز - اسم الجهة المستفيدة وعنوانها (للمستودعات فقط) .

ح- اسم المريض وعمره ورقم الهوية والملف الطبي ورقم الوصفة واسم من وصفها (للصيدلية فقط).

ط - الكمية الباقية .

4 - يجب أن تكتب السجلات بحبر غير قابل للمحو، وعند التعديل يوقع على ذلك.

5 - عند نهاية كل سنة يجب أن يكتب على السجل اسم مسؤول عهدة المواد المخدرة أو المؤثرات العقلية وتوقيعه، واسم مدير المنشأة - أو من ينيبه - وتوقيعه، وأن يختم السجل بالختم الرسمي للمنشأة .

6 - تحفظ السجلات لمدة عشر سنوات .

7 - يتم إتلاف السجلات بعد انقضاء المدة المحددة للحفظ بوساطة لجنة تشكل من ثلاثة أعضاء بقرار من مدير المنشأة أو من ينيبه، ويعد محضر بذلك.

8 - تتحقق الهيئة العامة للغذاء والدواء - بالتنسيق مع وزارة الصحة - مما يتوافر من تقنية حديثة في تسجيل جميع ما يرد إلى الصيدلية أو المستودع بما يكفل مراعاتها للشروط السابقة .

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 22 explained in plain English

This article imposes on pharmacy establishments a separate register for each medicine containing a narcotic or psychotropic substance, with serially numbered pages.

Register data at pharmacies and warehouses:

  • The scientific name of the medicine, its pharmaceutical form, concentration and volume, and the previous balance.
  • The quantity received, the batch number and expiry date, the source it came from and the date received, and the total.
  • The quantity dispensed, the batch number, the date of dispensing and the name and signature of the person who dispensed it.
  • For warehouses only: the name and address of the beneficiary body.
  • For the pharmacy only: the patient's name, age, ID number and medical file, the prescription number and the name of the prescriber.
  • The quantity remaining.

Writing and documentation: in ink that cannot be erased, with a signature on any amendment. At the end of each year the register records the name and signature of the person responsible for custody and the name and signature of the establishment's manager or his delegate, and is stamped with the official seal.

Retention and destruction: the registers are kept for ten years, then destroyed by a committee of three members by decision of the establishment's manager or his delegate, with a report.

Modern technology: the Saudi Food and Drug Authority, in coordination with the Ministry of Health, verifies any modern recording technology to ensure these conditions are met.

Anyone who runs a pharmacy or warehouse and needs to review their obligations can consult a lawyer specialized in commercial cases.

Practical example

A medicine warehouse in Dammam keeps a separate register for each narcotic medicine, and records in it at each dispensing the batch number, the date and the name and address of the beneficiary body, and keeps the register for ten years before a committee destroys it.

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 22 of the Saudi Narcotics Law Implementing Regulations

How many years are narcotic medicine registers kept?

Ten years, then they are destroyed by a committee of three members by decision of the establishment's manager or his delegate, with a report prepared.

May a narcotic substances register be amended?

The register is written in ink that cannot be erased, and an amendment must be signed.

Is a separate register required for each medicine?

Yes, pharmacy establishments must have a special register for each medicine containing a narcotic or psychotropic substance.

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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.