What steps are required to register a new health supplement under Kuwait's food and drug regulations?

Registering a health supplement in Kuwait is regulated by the Kuwait Drug and Food Control Administration under the Ministry of Health. It requires classification of the product as a supplement, submission of a registration application through a licensed local entity, compliance review, mandatory safety testing and then approval. A local Kuwaiti company or authorized distributor and a valid import license are mandatory, and the process typically takes around 3-6 months, with cost varying depending on testing and registration requirements. At Abdulrazzaq Abdullah and Partners Law firm- Kuwait, we assist with the process of documentation and registration.

The regulatory environment for health products in Kuwait is rigorous, primarily overseen by the Public Authority for Food and Nutrition (PAFN) and the Ministry of Health (MOH).

Summary of Regulatory Requirements

To provide you with a high-level overview:
- Registration: All dietary supplements must be formally registered and approved before they can be imported or sold. This involves a technical review of the product's formula and intended use.
- Ingredients & Labeling: Kuwait follows specific standards (often aligned with GCC/GSO standards) regarding permissible ingredients, dosage limits, and mandatory Arabic labeling requirements.
- Local Representation: An import license is required, and it is legally mandatory to have a local Kuwaiti distributor or agent to handle the registration and clearing of the products.
- Testing: Samples must be submitted for laboratory testing to verify safety and compliance with technical specifications.

Detailed Consultation

The full registration process, specific ingredient lists, exact timelines, and detailed cost breakdowns are subject to the specific nature of your products. Due to the technical complexity of these regulations, we can only share comprehensive details and a tailored fee proposal through a formal email exchange or a scheduled meeting.

At Al-Dostour Law Firm, we regularly assist international clients in navigating Kuwait’s regulatory landscape and securing the necessary permits for health and food products.