Article 40 of the Saudi Pharmaceutical Establishments Law
المادة 40 من نظام المنشآت والمستحضرات الصيدلانية والعشبية
The article requires the Authority's Board to issue the Implementing Regulations within 120 days of the law's publication in the Official Gazette, to take effect after the law comes into force.
Official text (Arabic)
This article has not been amended since the law was issued.
يصدر المجلس اللائحة خلال (مائة وعشرين) يوماً من تاريخ نشر النظام في الجريدة الرسمية، ويعمل بها بعد نفاذه.
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 40 explained in plain English
This article deals with the Implementing Regulations of the law in three provisions:
- Issuing body: the Board, which under Article 1 is the board of directors of the Saudi Food and Drug Authority.
- Deadline: within 120 days from the date of the law's publication in the Official Gazette.
- Start of application: the Regulations apply after the law comes into force.
Article 1 defines the Regulations as 'the Implementing Regulations of the law', so wherever the word 'Regulations' appears in the law, it means these Regulations issued by the Board. The deadline stated here is a deadline for issuing them, while their application is tied to the law's own entry into force, so they are not applied before it. Anyone dealing with provisions of the law that refer to the Regulations needs to read them alongside it.
Note the link with Article 41, which provides that this law replaces the Pharmaceutical Establishments and Products Law issued by Royal Decree No. M/31 dated 1/6/1425 AH. The article does not state the publication date or the date the Regulations were actually issued.
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 40 of the Saudi Pharmaceutical Establishments Law
Who issues the Implementing Regulations of the Pharmaceutical Establishments Law?
The board of directors of the Saudi Food and Drug Authority.
When must the Regulations be issued?
Within 120 days from the date the law is published in the Official Gazette.
When do the Regulations apply?
After the law comes into force.
More articles on Definitions of Pharmaceutical Preparations and Establishments
- Article 1
This article defines the key terms of the Law, such as pharmacist, pharmacy technician, pharmaceutical and herbal product, adulterated and spoiled products, and the types of establishments.
يقصد بالكلمات والعبارات الآتية - أينما وردت في هذا النظام - المعاني المبينة أمام كل منها ما لم يقتضِ السياق خلاف ذلك: النظام: نظام المنشآت والمستحضرات الصيدلاني
- Article 41
The article provides that this law replaces the Pharmaceutical Establishments and Products Law issued by Royal Decree No. M/31 of 1425 AH, and repeals anything that conflicts with it.
يحل النظام محل نظام المنشآت والمستحضرات الصيدلانية، الصادر بالمرسوم الملكي رقم (م/31) وتاريخ 1 / 6 / 1425هـ، ويلغي كل ما يتعارض معه من أحكام.
- Article 42
The article provides that the law takes effect 120 days after its publication in the Official Gazette.
يعمل بالنظام بعد (مائة وعشرين) يوماً من تاريخ نشره في الجريدة الرسمية.
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.