With the growing popularity of natural remedies, the demand for herbal products is on the rise.
With the growing popularity of natural remedies, the demand for herbal products is on the rise. However, entering the market legally requires a specific and regulated process. One of the most critical steps is obtaining a license from the Food and Drug Organization of Iran (IFDA), which ensures that the product is safe, effective, and meets national health standards.
A license from the Food and Drug Organization signifies that the product has passed regulatory evaluations and can be legally sold. It ensures consumer safety, enhances credibility, and protects both the manufacturer and end-user from potential legal and health risks.
The approval process generally consists of four essential steps:
Manufacturers must gather comprehensive documentation, including scientific reports, formulation data, production methods, and laboratory test results. Incomplete or vague submissions may lead to delays or rejection.
All product-related information must be submitted via the TTAC (Iran’s FDA electronic platform). This includes technical data, scientific files, labeling, and packaging information.
The organization’s experts thoroughly review the submitted documents. This step may involve technical evaluation, regulatory assessment, and in some cases, on-site inspections at the production facility.
If all criteria are met, the organization issues an official license for the herbal product. The license contains vital details such as health permit number, scope of use, and validity date.
To streamline the approval process, manufacturers are advised to consult regulatory specialists and accelerator companies. Their guidance can help ensure complete documentation and regulatory compliance, ultimately speeding up market entry.
