Article 26 of the Saudi Anti-Narcotics and Psychotropic Substances Law
المادة 26 من نظام مكافحة المخدرات والمؤثرات العقلية
The article makes the Ministry of Health the licensing authority for drug factories to make medical preparations containing narcotic substances, on condition that the conditions of a trade license are met and the license is held.
Official text (Arabic)
This article has not been amended since the law was issued.
يتم الترخيص لمصانع الأدوية بصنع مستحضرات طبية يدخل في تركيبها مواد مخدرة أو مؤثرات عقلية بموجب ترخيص من وزارة الصحة، على أن تتوافر في طالب الترخيص شروط الترخيص بالاتجار في المواد المخدرة وأن يكون حاصلا على هذا الترخيص.
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 26 explained in plain English
Many important medicines, such as some strong painkillers and anesthetics, contain narcotic or psychotropic substances in their composition. This article regulates licensing drug factories to make these preparations:
- Licensing authority: the Ministry of Health.
- Subject of the license: making medical preparations that contain narcotic or psychotropic substances in their composition.
- The two conditions:
- The applicant must meet the conditions for a license to trade in narcotic substances.
- He must actually hold a trade license.
A factory cannot start directly with a manufacturing license; it must first be licensed to trade in these substances. The article does not detail the conditions of the trade license, but refers to them without stating them.
This license differs from what appears in Article Twenty-Five, which makes establishing factories or laboratories for producing or separating narcotic substances subject to a decision of the Council of Ministers. The difference is that this article concerns making the medicine that contains the substance, not producing the substance itself. After it comes Article Twenty-Seven, which restricts the licensed factory, so that it may not dispose of the substances it obtains or use them except in making the preparations specified in the license, while following the provisions of the Law and its Regulations on registration and control. Anyone who needs advice on licensing requirements would do well to consult a lawyer specialized in administrative and commercial cases.
Practical example
A drug factory in the Eastern Province wants to add a production line for a cough syrup containing a narcotic substance in a certain proportion. The factory must first hold a license to trade in narcotic substances, and then ask the Ministry of Health for a license to make this preparation.
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 26 of the Saudi Anti-Narcotics and Psychotropic Substances Law
Who licenses drug factories to make medicines containing narcotic substances?
The Ministry of Health, on condition that the applicant meets the conditions for a license to trade in narcotic substances and holds it.
Does a drug factory need a trade license before a manufacturing license?
Yes. The article requires the applicant for a manufacturing license to hold a license to trade in narcotic substances.
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.