Before you begin
Confirm that your product is eligible and that you are authorized to submit its information. Have the current label, quantitative formulation, scientific support, safety information, and quality records ready.
Application steps
| Step | Information required |
|---|---|
| 1. Company | Responsible legal entity, authorized contact, and disclosures. |
| 2. Product | Name, version, category, dosage form, and sales market. |
| 3. Formulation | Ingredients, amounts, directions, and current label. |
| 4. Claims | Intended use and the exact claims submitted for review. |
| 5. Scientific evidence | Supporting sources and their relevance to the product. |
| 6. Safety and quality | Risk information, analytical records, and quality controls. |
| 7. Public information | Product details for publication if an award is granted. |
| 8. Confirmation | Review the completed application and declarations. |
Save a draft to return to it later. The application is submitted only when you confirm the declarations and select “Submit application.”
Confidential documents
Upload supporting files through the secure application fields. Keep the public product description separate from confidential evidence. Exclude payment-card details, identifiable patient information, and materials you lack permission to share.
After submission
Your receipt gives an application number and submission date. The initial completeness check has a target of 10 business days.
The 90-calendar-day review target begins on acceptance of a complete application. Time awaiting your response to information requests is excluded.
Terms of application
Submission confirms your authority, the accuracy of the information, required disclosures, and acceptance of the program rules. An award depends on meeting the criteria; submission alone does not guarantee a successful outcome.