Registration process
Spain vape product registration
Spain follows the EU Tobacco Products Directive (2014/40/EU) for product notifications but has an additional packaging file review step before products are listed. Notably, Spain does not require a 6-month waiting period before market launch.
Step 1: Prepare the Submission Data
Using TPD PRO, structure your product information into EU-CEG-compliant XML files:
Add Submitter and Manufacturer information
Create full Compositions with toxicological and emissions data
Define Presentations specifically for the Spanish market
Upload required files (emission reports, tox data, packaging, leaflet)
Step 2: Submit via eTrustEx
Log in to eTrustEx and submit the files in the following order:
Submitter XML
Attachments
Submission XML
Ensure each file receives a Success confirmation to complete the notification.
Step 3: Submit Packaging Files for Manual Review
After the XML submission, Spain requires an additional manual step:
Prepare final packaging print files and instruction leaflet in Spanish language
Include the list of EC-ID numbers corresponding to each product
Email these files to the Spanish Ministry of Health for validation and approval
📌 These files must match the product information already submitted via EU-CEG.
Step 4: Packaging File Check by the Authorities
The Spanish health authority will manually review the submitted packaging and leaflet materials.
If the files are accepted, products proceed to publication
If changes are needed, the authority will issue correction feedback via email
Step 5: Public Listing
Once packaging is approved, products are listed on Spain's official health registry:
This registry confirms that your product is legally notified and authorized for sale in Spain.
No Waiting Period
Unlike most other EU countries, Spain does not enforce a 6-month delay between submission and market entry.
Products can be placed on the Spanish market immediately after approval of packaging files.
Summary
To register products in Spain:
Submit via EU-CEG (TPD PRO + eTrustEx)
Prepare packaging and leaflet files in Spanish
Send files with EC-IDs to the Ministry of Health for approval
No 6-month waiting period is required
Products will be published on sanidad.gob.es