Requirements for Cosmetic Product Registration in GCC Countries
In Bahrain, Qatar, Kuwait, and Oman, cosmetic products must be registered or listed with the local Ministry of Health before being sold or distributed in the local market. The process ensures that products are safe for human use and comply with government standards.
Once approved, the product will receive a product listing or registration certificate that allows market entry.
Local Agent Requirement
Registration must be carried out through a local agent or distributor based in the respective country.
Classification and Regulatory Categories
Cosmetic products are classified into three categories based on their risk level:
Low-risk
Medium-risk
High-risk
The classification depends on ingredients, intended usage, and target audience.
Required Documents for Registration
To register a cosmetic product, the following documents are required:
Product image and artwork
Free Sale Certificate
Certificate of Analysis
Ingredient list and PIF (Product Information File)
GMP (Good Manufacturing Practice) Certificate
Safety Assessment Report
Laboratory Test Reports (if required)
Product Sample
Safety Assessment Report : Confirms product safety, including information on toxicity, allergenic substances, and clinical testing (if required).
Registration Process
Submission: Submit an application with all necessary documents to the relevant authority.
Evaluation: The local regulatory authority assesses and approves the application.
Approval: Once approved, the product receives a registration certificate, valid for up to 5 years (varies by country).
Post-Market Surveillance
After registration, companies must comply with post-market surveillance regulations:
Reporting any adverse effects.
Notifying authorities of any changes in product formulation or labeling.
Complying with recalls or corrective actions if necessary.