Sweden vape product registration

Step 1: Prepare the Submission Data

Use TPD PRO to prepare all necessary product data according to EU-CEG requirements:

• Create and activate Submitter

• Add Manufacturer, Composition, and Presentations for the Swedish market

• Upload required documents (e.g., emissions, tox data, leaflet, packaging)

• Generate the XML files for submission

Step 2: Submit via eTrustEx

Access eTrustEx and upload files in the required sequence:

1. Submitter XML

2. Attachments (PDFs)

3. Submission XML

Ensure all files are validated and marked Success by the system.

Step 3: Receive Invoice from the Authority

Within the 6-month notification period, you will receive an invoice from Folkhälsomyndigheten (Public Health Agency of Sweden):

• Fee: €1000 per product

• Payment is mandatory before the submission can be approved

• Monitor your provided contact email for the invoice

Step 4: Product Review & Verification

Once the invoice is paid, the authority will:

• Review the product data and attachments

• Verify compliance with Swedish regulations

• Provide feedback in case of missing or incorrect information

Step 5: 6-Month Notification Period

Sweden enforces the full 6-month waiting period from the date of submission.

Products may only be placed on the Swedish market after this period has passed and the payment is confirmed.

Step 6: Public Listing

Once approved, products will be listed in the official registry on the Public Health Agency’s website:

👉 www.folkhalsomyndigheten.se

This confirms the product is authorized for sale in Sweden.

Summary

To notify products in Sweden:

• Submit complete XML and attachments via eTrustEx

• Pay the €1000 fee per product upon receiving the invoice

• Wait 6 months from submission date

• Upon approval, products are listed on folkhalsomyndigheten.se