Estonia vape product registration

Step 1: Prepare the Submission

Use TPD PRO to generate a full product notification package in XML format:

• Submitter, Manufacturer, Composition, and Presentations for Estonia

• Attach necessary documents (e.g., emission tests, tox data, packaging, leaflet)

• Export and validate all files

Step 2: Submit via eTrustEx

Log in to eTrustEx and upload the files in proper sequence:

1. Submitter XML

2. Attachments (PDFs)

3. Submission XML

Wait for Success status confirmation after each file.

Step 3: Pay State Fees

Estonia charges a state fee per product for review and processing. As of 2024, the following fees apply:

Product notification review: €5,000

Notification modification: €740

Notification publishing & storage: €100 (not applied for late 2024 submissions)

💡 Note: For products submitted between 01.07.2024 and 31.12.2024,

• No sales volume notification is required in 2025

• No data storage fee applies in 2025

• If storage fee was already paid, email info@terviseamet.ee for refund coordination

If you pay for multiple products in one transaction and cannot fit all product names or brands in the payment reference, you must email that information separately to: tpd@terviseamet.ee

Step 4: Notify the Health Authority by Email

After making the payment:

1. Email tpd@terviseamet.ee

2. Include:

   • List of products covered by the payment

   • Corresponding EC-IDs or product names

   • Proof of payment (recommended)

This ensures your submissions are processed and matched correctly.

Step 5: Product Review

The Estonian Health Board will manually review each paid submission. If no issues are found, your product will proceed to listing.

⚠️ No product will be listed unless payment is confirmed and linked via email.

Step 6: Public Listing

After successful review, products will be listed on Estonia’s official health registry:

👉 www.terviseamet.ee

Summary

To notify products in Estonia:

• Prepare and submit via EU-CEG

• Pay the required state fee (€5,000 per product)

• Email product/payment info to tpd@terviseamet.ee

• Await review and final listing on terviseamet.ee

• Note: Some fees are waived for submissions between July–December 2024