Registration process
Romania vape product registration
Romania follows the EU Tobacco Products Directive (2014/40/EU) for notifying e-cigarettes, refill containers, and nicotine-containing products. The process includes submission via EU-CEG, followed by a 6-month waiting period before market access is granted.
🔐 Note: Romania's Ministry of Health website (www.ms.ro) is only accessible from within Romania or via Romanian VPN.
Step 1: Prepare the Submission
Use TPD PRO to compile your product data in EU-CEG-compliant XML format:
Submitter and Manufacturer details
Complete Compositions with ingredients and toxicological profiles
Presentations targeting the Romanian market
Upload all supporting documentation (emissions, leaflet, packaging, etc.)
Step 2: Submit via eTrustEx
Access eTrustEx and submit the files in the required sequence:
Submitter XML
Attachments (PDFs)
Submission XML
Make sure each file is validated and receives a Success confirmation.
Step 3: 6-Month Notification Period
Once the submission is accepted, Romania enforces a mandatory 6-month waiting period.
No products may be placed on the market until this period has passed.
Step 4: Public Listing
After successful validation and expiration of the waiting period, products will be listed on the official website of Romania’s Ministry of Health:
👉 www.ms.ro
(Note: site requires Romanian VPN to access)
This listing confirms the product is authorized for legal sale in Romania.
Summary
To notify products in Romania:
Prepare and submit product data via TPD PRO and eTrustEx
Observe a 6-month notification period
After approval, your products will be listed on ms.ro