Understanding the Thai FDA Cosmetic Notification Process
The Thai FDA cosmetic notification process has recently been divided into two steps, making it essential for manufacturers and importers to understand its intricacies to ensure compliance and avoid delays.
Step 1: Product Data Entry and Algorithm Approval
The first step in the Thai FDA cosmetic notification process involves entering the product data into the FDA system. An algorithm reviews the submitted information, and if everything meets the initial criteria, the product is automatically approved. An FDA notification number is then issued, allowing the product to move forward in the process.
Step 2: Post Audit by Human Officer
The second step, known as the “post audit,” is where a human officer conducts a thorough review of the product, particularly focusing on “controlled cosmetics” or “high-risk cosmetics.” This step assesses the claims and commercial names associated with the product. The review is conducted by an officer in the applicant’s province and can take from 15 to 25 days or even longer. When a product is subject to post audit, the ability to download the license is blocked, and the operator is requested to provide additional explanations. If the required documents are provided, the product is approved. If not, the product remains in a limbo, unable to receive a certificate of notification.
Issues with the Notification System
The Thai FDA aimed to streamline the process for low-risk cosmetics by implementing immediate approvals. However, the system currently cannot distinguish between low and high-risk products, resulting in all products undergoing the post audit. This additional review step has led to significant delays, with about 50% of products being flagged for further information.
Consequently, the Thai FDA cosmetic notification is not as immediate as intended, and applicants must navigate the post-audit process to ensure their products are fully compliant and market-ready.
Risks and Responsibilities
Despite receiving a notification number immediately, products often face delays during the post-audit phase. If the operator fails to respond to requests for further information, the product may be blocked at customs. This highlights the critical role of consultants, whose actions can significantly impact the importer or manufacturer. Inadequate consultancy can lead to blocked imports, especially if issues arise with the commercial name or other documentation.
Future Scenarios
The current challenges with the cosmetic notification process suggest that changes are likely. To mitigate the issues faced by manufacturers unfamiliar with regulatory requirements, the Thai FDA may mandate post audits for all cosmetics, eliminating the initial self-approval step.
Conclusion on Thai FDA Cosmetic Notification – Post Audit
To avoid complications during import or post-market stages, it is crucial to comply with the Thai FDA cosmetic notification requirements. We recommend working with knowledgeable consultants who prioritize ethical practices and thorough compliance to prevent future market issues. For more information and assistance, please contact us.
Stay Informed: We are committed to keeping you updated on any changes to the Thai FDA cosmetic notification process. Ensuring compliance can be challenging, but it is essential for smooth market operations.
