Article 27 of the Saudi Anti-Narcotics and Psychotropic Substances Law
المادة 27 من نظام مكافحة المخدرات والمؤثرات العقلية
The article bars licensed factories from disposing of narcotic substances they obtain or using them except in making the preparations specified in the license, while following the registration and control provisions.
Official text (Arabic)
This article has not been amended since the law was issued.
لا يجوز للمصانع المرخص لها التصرف في المواد المخدرة أو المؤثرات العقلية الحاصلة عليها أو استعمالها إلا في صنع المستحضرات الطبية المحددة في الترخيص. وعليها اتباع الأحكام الواردة في هذا النظام ولائحته بشأن تسجيل هذه المواد والتصرف فيها ومراقبتها.
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 27 explained in plain English
After drug factories obtain a license to make preparations containing narcotic or psychotropic substances, this article sets limits on what they may do with these substances:
- Restricting use: licensed factories may not dispose of the narcotic or psychotropic substances they obtained, nor use them, except in making the medical preparations specified in the license. They may not be used in another unlicensed preparation, nor sold or transferred to another body under this article.
- Following the oversight provisions: factories must follow the provisions of the Law and its Regulations on registering these substances, disposing of them and monitoring them.
The license here is tied to specific preparations, and every quantity the factories obtain is tied to this purpose. The article does not detail the provisions on registration and control, but refers to the Law and its Regulations generally.
This article complements Article Twenty-Six, which makes licensing drug factories to make these preparations a matter for the Ministry of Health, on condition that the applicant meets the conditions for a trade license and holds it. After it comes Article Twenty-Eight, which requires these substances to be kept in licensed establishments in a special place within their original containers in a tight manner that prevents tampering. Anyone who needs advice on a factory's obligations would do well to consult a lawyer specialized in health and commercial regulations.
Practical example
A drug factory in Jeddah is licensed to make painkilling injections containing a narcotic substance. The factory has a surplus of the raw substance and wanted to use it to make tablets not mentioned in the license. This is not permitted, because use of the substance is limited to the preparations specified in the license.
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 27 of the Saudi Anti-Narcotics and Psychotropic Substances Law
May a drug factory use the narcotic substance in an unlicensed medicine?
No. It may not use it or dispose of it except in making the medical preparations specified in the license.
Which provisions must licensed factories follow?
The provisions of the Law and its Regulations on registering narcotic substances, disposing of them and monitoring them.
More articles on Licensing Narcotics for Medical Purposes
- Article 2
The article excludes emergency and first-aid medicines containing narcotic substances carried on ships and aircraft from importation, exportation and smuggling, on specific conditions.
لا يعد جلبا أو تصديرا أو تهريبا الكميات المحددة من الأدوية الطبية التي تحتوي على مواد مخدرة أو مؤثرات عقلية تحملها وسائط النقل، كالسفن والطائرات، لمواجهة الحالا
- Article 12
The article requires a one-year renewable license from the Ministry of Health to import or export narcotic or psychotropic substances for legitimate purposes.
لا يجوز استيراد المواد المخدرة أو المؤثرات العقلية أو تصديرها لأغراض مشروعة إلا بموجب رخصة استيراد أو تصدير صادرة من وزارة الصحة. وتمنح الرخصة لمدة سنة قابلة لل
- Article 13
The article limits granting a license to import or export narcotic or psychotropic substances to five categories of pharmaceutical, treatment and research establishments.
يقصر منح رخصة استيراد المواد المخدرة أو المؤثرات العقلية أو تصديرها على المنشآت الآتية: 1 - شركات الأدوية ووكلائها. 2 - مستودعات بيع الأدوية بالجملة. 3 - المؤسس
- Article 14
The article requires narcotic or psychotropic substances to be imported or exported in tightly sealed parcels with a detailed statement, with no other substance in the parcel.
لا يجوز استيراد مواد مخدرة أو مؤثرات عقلية أو تصديرها إلا داخل طرود محكمة الإغلاق، مع بيان يحدد اسم المادة وكميتها وتركيزها وشكلها الصيدلاني حتى لو كانت عينة. و
- Article 15
The article gives the Ministry of Health the power to review the quantity requested for import or export of narcotic substances and to approve, amend or reject it according to the Regulations.
لوزارة الصحة مراجعة الكمية المطلوب استيرادها أو تصديرها للموافقة عليها أو تعديلها أو رفضها وفق الضوابط التي تحددها اللائحة .
- Article 16
The article bars releasing narcotic or psychotropic substances arriving at customs except under a release license from the Ministry of Health, which is returned to it after the release.
لا يجوز تسليم المواد المخدرة أو المؤثرات العقلية التي تصل إلى الجمارك إلا بموجب رخصة فسح صادرة من وزارة الصحة، على أن تعاد هذه الرخصة إليها بعد انتهاء الفسح.
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.