Article 16 of the Saudi Cosmetics Law
المادة 16 من نظام منتجات التجميل
The article requires the factory to notify the Authority of any change in it, its products or the information it provided, and bars operating it outside what it is licensed for.
Official text (Arabic)
This article has not been amended since the law was issued.
يلتزم المصنع بإبلاغ الهيئة عن أي تغيير فيه أو في منتجاته أو المعلومات التي قدمها، ولا يجوز تشغيل المصنع في غير ما رخص له.
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 contains two continuing obligations on a cosmetic products factory after it obtains its license:
- Reporting any change: The factory must notify the Saudi Food and Drug Authority of any change in three things:
- The factory itself.
- Its products.
- The information it previously provided to the Authority.
- Not exceeding the license: The factory may not be operated outside what it is licensed for; the license defines the scope of the activity and it may not be departed from.
The phrase "any change" is general, so the text sets no minimum size for a change that must be reported, and no deadline or method for reporting. The apparent purpose is for the Authority's information about the factory, which it provided when applying for the license and afterwards, to remain consistent with reality.
This article is linked to Article 15, which requires a full-time Saudi technical manager, and to Article 17, which bars the factory from starting to market any product before it is listed. If the factory wants to add a new product, it must notify the Authority of the change in its products, and list the product before marketing it.
Anyone who wants to check whether a particular change requires notification or an amendment of the license can consult a lawyer specializing in commercial law and food and drug law.
Practical example
A factory in Dammam is licensed to produce liquid soap and decides to add a line producing hair dyes. It must notify the Authority of this change, and may not operate the factory in an activity it is not licensed for.
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 16 of the Saudi Cosmetics Law
Must I notify the Food and Drug Authority when something changes at the factory?
Yes. The factory must notify the Authority of any change in it, its products or the information it provided.
May a factory produce something outside its license?
No. The article provides that the factory may not be operated outside what it is licensed for.
Does the article set a deadline for reporting a change?
No. The article requires reporting without stating a particular deadline or method.
More articles on Licensing of Cosmetics Factories
- Article 13
The article requires a technical license from the Authority for a cosmetic products factory, under the requirements and conditions set by the Implementing Regulations.
يجب الحصول على ترخيص فني للمصنع من الهيئة وفقًا للمتطلبات والشروط التي تحددها اللائحة.
- Article 14
The article sets out the procedures for the technical license of a cosmetics factory: an application decided within 30 days by preliminary approval or reasoned refusal, then a license after the necessary approvals and confirmation that GMP is applied.
يتم الحصول على الترخيص الفني للمصنع وفقًا للإجراءات الآتية: 1 - يقدم طلب للهيئة وفقًا للمتطلبات والشروط التي تحددها اللائحة، وتبت الهيئة في الطلب خلال مدة لا تت
- Article 15
The article requires a cosmetic products factory to have a full-time Saudi technical manager, as set by the Implementing Regulations.
يجب أن يكون للمصنع مدير فني سعودي متفرغ تفرغًا كاملًا وفقًا لما تحدده اللائحة.
- Article 17
The article bars the factory from starting to market a cosmetic product until it has been listed with the Authority.
لا يجوز للمصنع أن يبدأ تسويق المنتج التجميلي إلا بعد إدراجه.
- Article 18
The article requires the factory to apply good manufacturing practices (GMP) and allows the Authority to confirm this whenever needed under the Implementing Regulations' procedures.
يلتزم المصنع بتطبيق أسس التصنيع الجيد (GMP)، وللهيئة التأكد من ذلك كلما دعت الحاجة، وفقًا للإجراءات التي تحددها اللائحة.
- Article 20
The article sets the duration of a cosmetic products factory or warehouse license at five years, renewable.
مدة الترخيص للمصنع أو المستودع خمس سنوات قابلة للتجديد.
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.